Trial Outcomes & Findings for Clinical Trial Comparing C-Brace to Knee Ankle Foot Orthosis (KAFO)/Stance Control Orthosis (SCO) (NCT NCT03906656)
NCT ID: NCT03906656
Last Updated: 2024-09-19
Results Overview
The Berg Balance Scale is a 14-item scale designed to measure static and dynamic balance in adults in a clinical setting. The range in score for the BBS is 0 to 56, with higher scores indicating better balance. Points for each item are deducted if the time or distance requirements are not met, the patient's performance requires supervision, or the patient requires assistance from support or examiner.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
149 participants
Primary outcome timeframe
Baseline, 3 months after initial home use period, and 3 months after cross-over home use period
Results posted on
2024-09-19
Participant Flow
Potential participants were pre-screened based on their medical and/or orthotic records. After signing a written informed consent, participants were screened for inclusion and exclusion criteria. The screening process comprised a thorough patient evaluation and a test with the functional C-Brace trial tool to check whether the potential study participant was able to initiate swing and utilize controlled knee flexion during weight bearing.
149 subjects were enrolled, and 41 failed screening (27 due to BBS score above 44, 11 failed the C-Brace trial tool assessment, 1 had a contraindication for the C-Brace, 1 had a history of vertigo, and 1 was geographically inaccessible). In addition, another 6 subjects dropped out after screening, but prior to randomization. Reasons for these early dropouts were lack of time (2) and personal problems (1) resulting in 102 patients randomized.
Participant milestones
| Measure |
KAFO/SCO, Then C-Brace
Home use of 3 months with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)
KAFO/SCO: Current knee ankle foot orthosis that the subject was wearing at baseline
Crossover immediately after first home-use period to being fit with C-Brace, receiving training, and starting 3-month home-use period as soon as the subject demonstrates he/she is able to use it safely.
|
C-Brace, Then KAFO/SCO
Home use of 3 months with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.
C-Brace: The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint.
Crossover to wearing previous KAFO/SCO, receives training if necessary, wears KAFO/SCO for a 1-month washout period then starting 3-month KAFO/SCO home-use period.
|
|---|---|---|
|
Fitting/Assessment Prior to Home Use 1
STARTED
|
52
|
50
|
|
Fitting/Assessment Prior to Home Use 1
COMPLETED
|
50
|
47
|
|
Fitting/Assessment Prior to Home Use 1
NOT COMPLETED
|
2
|
3
|
|
Home Use 1 (3 Months)
STARTED
|
50
|
47
|
|
Home Use 1 (3 Months)
COMPLETED
|
47
|
44
|
|
Home Use 1 (3 Months)
NOT COMPLETED
|
3
|
3
|
|
Fitting/Assessment Prior to Home Use 2
STARTED
|
47
|
44
|
|
Fitting/Assessment Prior to Home Use 2
COMPLETED
|
41
|
43
|
|
Fitting/Assessment Prior to Home Use 2
NOT COMPLETED
|
6
|
1
|
|
Home Use 2 (3 Months)
STARTED
|
41
|
43
|
|
Home Use 2 (3 Months)
COMPLETED
|
35
|
41
|
|
Home Use 2 (3 Months)
NOT COMPLETED
|
6
|
2
|
Reasons for withdrawal
| Measure |
KAFO/SCO, Then C-Brace
Home use of 3 months with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)
KAFO/SCO: Current knee ankle foot orthosis that the subject was wearing at baseline
Crossover immediately after first home-use period to being fit with C-Brace, receiving training, and starting 3-month home-use period as soon as the subject demonstrates he/she is able to use it safely.
|
C-Brace, Then KAFO/SCO
Home use of 3 months with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.
C-Brace: The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint.
Crossover to wearing previous KAFO/SCO, receives training if necessary, wears KAFO/SCO for a 1-month washout period then starting 3-month KAFO/SCO home-use period.
|
|---|---|---|
|
Fitting/Assessment Prior to Home Use 1
Withdrawal by Subject
|
1
|
0
|
|
Fitting/Assessment Prior to Home Use 1
Adverse Event
|
0
|
1
|
|
Fitting/Assessment Prior to Home Use 1
Lack of access to site during COVID
|
0
|
1
|
|
Fitting/Assessment Prior to Home Use 1
Lack of Efficacy
|
0
|
1
|
|
Fitting/Assessment Prior to Home Use 1
Lost to Follow-up
|
1
|
0
|
|
Home Use 1 (3 Months)
Adverse Event
|
1
|
2
|
|
Home Use 1 (3 Months)
Withdrawal by Subject
|
1
|
0
|
|
Home Use 1 (3 Months)
Lack of Efficacy
|
0
|
1
|
|
Home Use 1 (3 Months)
Protocol Violation
|
1
|
0
|
|
Fitting/Assessment Prior to Home Use 2
Adverse Event
|
2
|
0
|
|
Fitting/Assessment Prior to Home Use 2
Lack of access to site during COVID
|
1
|
0
|
|
Fitting/Assessment Prior to Home Use 2
Withdrawal by Subject
|
1
|
0
|
|
Fitting/Assessment Prior to Home Use 2
Lack of Efficacy
|
1
|
0
|
|
Fitting/Assessment Prior to Home Use 2
Personal problems
|
0
|
1
|
|
Fitting/Assessment Prior to Home Use 2
Lost to Follow-up
|
1
|
0
|
|
Home Use 2 (3 Months)
Adverse Event
|
1
|
1
|
|
Home Use 2 (3 Months)
Lost to Follow-up
|
2
|
0
|
|
Home Use 2 (3 Months)
Death
|
2
|
0
|
|
Home Use 2 (3 Months)
Lack of Efficacy
|
1
|
0
|
|
Home Use 2 (3 Months)
Could not cope with KAFO after C-Brace
|
0
|
1
|
Baseline Characteristics
Missing data for one patient
Baseline characteristics by cohort
| Measure |
KAFO/SCO, Then C-Brace
n=52 Participants
Home use of 3 months with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)
KAFO/SCO: Current knee ankle foot orthosis that the subject was wearing at baseline
Crossover immediately after first home-use period to being fit with C-Brace, receiving training, and starting 3-month home-use period as soon as the subject demonstrates he/she is able to use it safely.
|
C-Brace, Then KAFO/SCO
n=50 Participants
Home use of 3 months with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.
C-Brace: The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint.
Crossover to wearing previous KAFO/SCO, receives training if necessary, wears KAFO/SCO for a 1-month washout period then starting 3-month KAFO/SCO home-use period.
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.1 years
STANDARD_DEVIATION 15.2 • n=52 Participants
|
55.4 years
STANDARD_DEVIATION 12.4 • n=50 Participants
|
55.8 years
STANDARD_DEVIATION 13.8 • n=102 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=52 Participants
|
19 Participants
n=50 Participants
|
45 Participants
n=102 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=52 Participants
|
31 Participants
n=50 Participants
|
57 Participants
n=102 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
40 Participants
n=52 Participants
|
38 Participants
n=50 Participants
|
78 Participants
n=102 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=52 Participants
|
6 Participants
n=50 Participants
|
12 Participants
n=102 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=52 Participants
|
2 Participants
n=50 Participants
|
4 Participants
n=102 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=52 Participants
|
4 Participants
n=50 Participants
|
8 Participants
n=102 Participants
|
|
Region of Enrollment
Netherlands
|
4 participants
n=52 Participants
|
3 participants
n=50 Participants
|
7 participants
n=102 Participants
|
|
Region of Enrollment
Austria
|
0 participants
n=52 Participants
|
1 participants
n=50 Participants
|
1 participants
n=102 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=52 Participants
|
22 participants
n=50 Participants
|
42 participants
n=102 Participants
|
|
Region of Enrollment
Germany
|
28 participants
n=52 Participants
|
24 participants
n=50 Participants
|
52 participants
n=102 Participants
|
|
Body Weight
|
77.5 kg
STANDARD_DEVIATION 15.8 • n=52 Participants
|
82.8 kg
STANDARD_DEVIATION 16.3 • n=50 Participants
|
80.1 kg
STANDARD_DEVIATION 16.2 • n=102 Participants
|
|
Height
|
170.1 cm
STANDARD_DEVIATION 11.3 • n=52 Participants
|
170.3 cm
STANDARD_DEVIATION 11.3 • n=50 Participants
|
170.2 cm
STANDARD_DEVIATION 11.2 • n=102 Participants
|
|
Work/employment status
Employed
|
17 Participants
n=52 Participants
|
25 Participants
n=50 Participants
|
42 Participants
n=102 Participants
|
|
Work/employment status
Retired
|
22 Participants
n=52 Participants
|
21 Participants
n=50 Participants
|
43 Participants
n=102 Participants
|
|
Work/employment status
Unemployed
|
13 Participants
n=52 Participants
|
4 Participants
n=50 Participants
|
17 Participants
n=102 Participants
|
|
Side/bilateral orthosis
Right
|
18 Participants
n=52 Participants
|
23 Participants
n=50 Participants
|
41 Participants
n=102 Participants
|
|
Side/bilateral orthosis
Left
|
26 Participants
n=52 Participants
|
21 Participants
n=50 Participants
|
47 Participants
n=102 Participants
|
|
Side/bilateral orthosis
Bilateral
|
8 Participants
n=52 Participants
|
6 Participants
n=50 Participants
|
14 Participants
n=102 Participants
|
|
Type of orthosis used before study and as control
Locked KAFO
|
22 participants
n=52 Participants
|
23 participants
n=50 Participants
|
45 participants
n=102 Participants
|
|
Type of orthosis used before study and as control
Posterior-offset KAFO
|
15 participants
n=52 Participants
|
14 participants
n=50 Participants
|
29 participants
n=102 Participants
|
|
Type of orthosis used before study and as control
SCO (electrical)
|
9 participants
n=52 Participants
|
5 participants
n=50 Participants
|
14 participants
n=102 Participants
|
|
Type of orthosis used before study and as control
SCO (mechanical)
|
11 participants
n=52 Participants
|
13 participants
n=50 Participants
|
24 participants
n=102 Participants
|
|
Type of orthosis used before study and as control
Other
|
1 participants
n=52 Participants
|
1 participants
n=50 Participants
|
2 participants
n=102 Participants
|
|
Use of walking aids inside
Yes
|
31 Participants
n=51 Participants • Missing data for one patient
|
30 Participants
n=50 Participants • Missing data for one patient
|
61 Participants
n=101 Participants • Missing data for one patient
|
|
Use of walking aids inside
No
|
20 Participants
n=51 Participants • Missing data for one patient
|
20 Participants
n=50 Participants • Missing data for one patient
|
40 Participants
n=101 Participants • Missing data for one patient
|
|
Use of walking aids outside
Yes
|
44 Participants
n=51 Participants • Missing data for one patient
|
42 Participants
n=50 Participants • Missing data for one patient
|
86 Participants
n=101 Participants • Missing data for one patient
|
|
Use of walking aids outside
No
|
7 Participants
n=51 Participants • Missing data for one patient
|
8 Participants
n=50 Participants • Missing data for one patient
|
15 Participants
n=101 Participants • Missing data for one patient
|
PRIMARY outcome
Timeframe: Baseline, 3 months after initial home use period, and 3 months after cross-over home use periodPopulation: Intention to Treat Analysis
The Berg Balance Scale is a 14-item scale designed to measure static and dynamic balance in adults in a clinical setting. The range in score for the BBS is 0 to 56, with higher scores indicating better balance. Points for each item are deducted if the time or distance requirements are not met, the patient's performance requires supervision, or the patient requires assistance from support or examiner.
Outcome measures
| Measure |
Baseline
n=102 Participants
Baseline measure with currently worn knee ankle foot orthosis (KAFO) or stance control orthosis (SCO)
|
KAFO
n=86 Participants
Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)
|
C-Brace
n=77 Participants
Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.
C-Brace: The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint.
|
|---|---|---|---|
|
Primary Efficacy: Berg Balance Scale (BBS)
|
33.6 score on a scale
Standard Deviation 11.0
|
37.3 score on a scale
Standard Deviation 10.5
|
42.0 score on a scale
Standard Deviation 9.1
|
SECONDARY outcome
Timeframe: Baseline, 3 months after initial home use period, and 3 months after cross-over home use periodPopulation: Intention to Treat Group
Assessment of patient-perceived balance confidence for 16 activities of daily living. For each activity, subjects rate their level of confidence in doing the activity without losing their balance or becoming unsteady on a scale from 0% to 100%, with 100% being the highest level of confidence. The total score for the ABC scale is an average of all activity scores.
Outcome measures
| Measure |
Baseline
n=96 Participants
Baseline measure with currently worn knee ankle foot orthosis (KAFO) or stance control orthosis (SCO)
|
KAFO
n=81 Participants
Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)
|
C-Brace
n=77 Participants
Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.
C-Brace: The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint.
|
|---|---|---|---|
|
Activity-specific Balance Confidence (ABC) Scale
|
53.1 score on a scale
Standard Deviation 19.2
|
51.0 score on a scale
Standard Deviation 18.3
|
62.3 score on a scale
Standard Deviation 19.5
|
SECONDARY outcome
Timeframe: Baseline, 3 months after initial home use period, and 3 months after cross-over home use periodPopulation: Intention to Treat Group
An 8-item test used to assess balance during walking tasks. It has a maximum score of 24 with each item being scored 0-3. A higher score indicates greater balance, and subjects lose a a point on all items for which an assistive device is needed.
Outcome measures
| Measure |
Baseline
n=99 Participants
Baseline measure with currently worn knee ankle foot orthosis (KAFO) or stance control orthosis (SCO)
|
KAFO
n=84 Participants
Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)
|
C-Brace
n=77 Participants
Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.
C-Brace: The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint.
|
|---|---|---|---|
|
Dynamic Gait Index (DGI)
|
12.3 score on a scale
Standard Deviation 3.3
|
13.4 score on a scale
Standard Deviation 3.2
|
15.7 score on a scale
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: Baseline, 3 months after initial home use period, and 3 months after cross-over home use periodPopulation: Intention to Treat Group
Distance walked in 6 minutes over 12-meter back-and-forth pathway as a measure of functional exercise capacity.
Outcome measures
| Measure |
Baseline
n=101 Participants
Baseline measure with currently worn knee ankle foot orthosis (KAFO) or stance control orthosis (SCO)
|
KAFO
n=86 Participants
Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)
|
C-Brace
n=77 Participants
Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.
C-Brace: The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint.
|
|---|---|---|---|
|
6-minute Walk Test
|
204.9 meters
Standard Deviation 73.9
|
213.7 meters
Standard Deviation 80.9
|
226.0 meters
Standard Deviation 84.3
|
SECONDARY outcome
Timeframe: Baseline, 3 months after initial home use period, and 3 months after cross-over home use periodPopulation: Intention to Treat Group
A 14-point ordinal scale (0 - 13) used to assess different gait patterns during descent of stairs. The range of total scores for the SAI is from 0 to 26, with a higher score indicating a more normative gait pattern and needing less assistance.
Outcome measures
| Measure |
Baseline
n=99 Participants
Baseline measure with currently worn knee ankle foot orthosis (KAFO) or stance control orthosis (SCO)
|
KAFO
n=86 Participants
Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)
|
C-Brace
n=76 Participants
Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.
C-Brace: The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint.
|
|---|---|---|---|
|
Stair Assessment Index (SAI) - Down
|
4 score on a scale
Standard Deviation 3.3
|
4.5 score on a scale
Standard Deviation 3.5
|
6 score on a scale
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: Baseline, 3 months after initial home use period, and 3 months after cross-over home use periodPopulation: Intention to Treat Group
Frequency of falling by using C-Brace compared to KAFO/SCO as measured by the number of falls in 3-month period by recollection at baseline and recorded in a Falls Diary during home-use periods
Outcome measures
| Measure |
Baseline
n=101 Participants
Baseline measure with currently worn knee ankle foot orthosis (KAFO) or stance control orthosis (SCO)
|
KAFO
n=87 Participants
Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)
|
C-Brace
n=79 Participants
Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.
C-Brace: The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint.
|
|---|---|---|---|
|
Frequency of Falling
|
4.9 number of falls in a three month period
Standard Deviation 20.1
|
4.0 number of falls in a three month period
Standard Deviation 16.8
|
1.1 number of falls in a three month period
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: Baseline, 3 months after initial home use period, and 3 months after cross-over home use periodPopulation: Intention to Treat Group
Two questions on patients' fear of falling indoors and outdoors based on an 11-point scale (0 = no fear, 10 = max. fear). The total score will range from 0 to 20, with 20 being maximum fear of falling.
Outcome measures
| Measure |
Baseline
n=100 Participants
Baseline measure with currently worn knee ankle foot orthosis (KAFO) or stance control orthosis (SCO)
|
KAFO
n=86 Participants
Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)
|
C-Brace
n=78 Participants
Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.
C-Brace: The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint.
|
|---|---|---|---|
|
Fear of Falling
Fear of falling outdoors
|
5.5 score on a scale
Standard Deviation 3.0
|
5.2 score on a scale
Standard Deviation 2.9
|
4.4 score on a scale
Standard Deviation 3.0
|
|
Fear of Falling
Fear of falling indoors
|
3.3 score on a scale
Standard Deviation 2.9
|
3.3 score on a scale
Standard Deviation 2.8
|
2.2 score on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: 3 months after initial home use period, and 3 months after cross-over home use periodPopulation: Paired data including subjects with fall history after both KAFO and C-Brace home use periods
Proportion of subjects having reported falling more than once will be compared between KAFO and C-Brace home-use periods
Outcome measures
| Measure |
Baseline
n=75 Participants
Baseline measure with currently worn knee ankle foot orthosis (KAFO) or stance control orthosis (SCO)
|
KAFO
n=75 Participants
Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)
|
C-Brace
Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.
C-Brace: The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint.
|
|---|---|---|---|
|
Probability of Falling More Than Once When Using C-Brace Compared to KAFO/SCO
|
25 Participants
|
12 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3 months after initial home use period, and 3 months after cross-over home use periodPopulation: Intention to Treat Group
11 items measuring satisfaction regarding perceived physical functioning, and social and emotional life. Higher scores represent higher levels of participation. The range of the adjusted total score is 0 to 100.
Outcome measures
| Measure |
Baseline
n=100 Participants
Baseline measure with currently worn knee ankle foot orthosis (KAFO) or stance control orthosis (SCO)
|
KAFO
n=86 Participants
Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)
|
C-Brace
n=76 Participants
Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.
C-Brace: The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint.
|
|---|---|---|---|
|
Reintegration to Normal Living (RNL) Index Questionnaire
|
71.5 score on a scale
Standard Deviation 19.8
|
71.7 score on a scale
Standard Deviation 17.6
|
74.0 score on a scale
Standard Deviation 19.8
|
SECONDARY outcome
Timeframe: Baseline, 3 months after initial home use period, and 3 months after cross-over home use periodPopulation: Intention to Treat Group
Measure of health status composed of 5 dimensions: mobility, ability to self-care, ability to undertake usual activities, pain and discomfort, anxiety and depression. Each dimension is rated on a 5-point scale indicating the level of perceived problems for each dimension (level 1 indicating no problems and level 5 indicating extreme problems). The raw score is then aggregated and normalized based on region to a 0 to 1 scale (where 0 represents maximum issues and 1 represents no problems).
Outcome measures
| Measure |
Baseline
n=99 Participants
Baseline measure with currently worn knee ankle foot orthosis (KAFO) or stance control orthosis (SCO)
|
KAFO
n=88 Participants
Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)
|
C-Brace
n=75 Participants
Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.
C-Brace: The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint.
|
|---|---|---|---|
|
EQ-5D-5L
|
0.71 score on a scale
Standard Deviation 0.19
|
0.72 score on a scale
Standard Deviation 0.19
|
0.74 score on a scale
Standard Deviation 0.18
|
SECONDARY outcome
Timeframe: Baseline, 3 months after initial home use period, and 3 months after cross-over home use periodPopulation: Intention to Treat Group. If one or more items in a subscale were not answered, the patient was excluded from the analysis of that particular subscale.
25-item questionnaire to evaluate at-work disability and productivity loss under four sub-scales: time demands, physical demands, mental/interpersonal demands, and output demands. Scale scores range from 0 (limited none of the time) to 100 (limited all of the time).
Outcome measures
| Measure |
Baseline
n=38 Participants
Baseline measure with currently worn knee ankle foot orthosis (KAFO) or stance control orthosis (SCO)
|
KAFO
n=34 Participants
Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)
|
C-Brace
n=30 Participants
Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.
C-Brace: The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint.
|
|---|---|---|---|
|
Work Limitations Questionnaires WLQ-25
Mental/Interpersonal
|
86.1 score on a scale
Standard Deviation 13.3
|
88.4 score on a scale
Standard Deviation 11.5
|
91.0 score on a scale
Standard Deviation 13.7
|
|
Work Limitations Questionnaires WLQ-25
Output
|
82.0 score on a scale
Standard Deviation 17.9
|
81.9 score on a scale
Standard Deviation 17.0
|
84.6 score on a scale
Standard Deviation 17.3
|
|
Work Limitations Questionnaires WLQ-25
Physical
|
37.5 score on a scale
Standard Deviation 24.8
|
34.5 score on a scale
Standard Deviation 23.3
|
24.3 score on a scale
Standard Deviation 18.8
|
|
Work Limitations Questionnaires WLQ-25
Time
|
79.2 score on a scale
Standard Deviation 20.1
|
78.3 score on a scale
Standard Deviation 24.6
|
79.8 score on a scale
Standard Deviation 19.8
|
SECONDARY outcome
Timeframe: Baseline, 3 months after initial home use period, and 3 months after cross-over home use periodPopulation: Intention to Treat Group. If one or more items in a subscale were not answered, the patient was excluded from the analysis of that particular subscale.
A self-report questionnaire designed to evaluate the outcome of orthotic and prosthetic services. Three of the five domains will be administered: lower extremity functional status (20 items, score ranges from 0 - 80, with high score being easier), health-related quality of life index (23 items, score ranges from 0 - 92, with higher score being better) and satisfaction with device (11 items, score ranges from 11 - 55, with higher score being more satisfaction) scales. The domains of upper limb functional measure and satisfaction with service are not applicable in this study.
Outcome measures
| Measure |
Baseline
n=99 Participants
Baseline measure with currently worn knee ankle foot orthosis (KAFO) or stance control orthosis (SCO)
|
KAFO
n=86 Participants
Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)
|
C-Brace
n=77 Participants
Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.
C-Brace: The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint.
|
|---|---|---|---|
|
Orthotics & Prosthetics User Survey (OPUS)
Quality of Life
|
56.6 score on a scale
Standard Deviation 7.3
|
56.9 score on a scale
Standard Deviation 6.9
|
58.0 score on a scale
Standard Deviation 8.0
|
|
Orthotics & Prosthetics User Survey (OPUS)
Lower Extremity Functional Status
|
45.3 score on a scale
Standard Deviation 6.2
|
46.6 score on a scale
Standard Deviation 6.3
|
48.8 score on a scale
Standard Deviation 6.3
|
|
Orthotics & Prosthetics User Survey (OPUS)
Satisfaction with Device
|
49.8 score on a scale
Standard Deviation 10.5
|
50.6 score on a scale
Standard Deviation 9.7
|
51.3 score on a scale
Standard Deviation 13.7
|
SECONDARY outcome
Timeframe: Baseline, 3 months after initial home use period, and 3 months after cross-over home use periodPopulation: Intention to Treat Group. If one or more items in a subscale were not answered, the patient was excluded from the analysis of that particular subscale.
36-item scale constructed to survey health status and quality of life. It assesses eight health concept scales: physical functioning, role functioning/physical, role functioning/emotional, energy/fatigue, emotional well-being, social functioning, pain and general health. Each scale score ranges from 0 to 100 with 100 being the highest (better) score.
Outcome measures
| Measure |
Baseline
n=99 Participants
Baseline measure with currently worn knee ankle foot orthosis (KAFO) or stance control orthosis (SCO)
|
KAFO
n=88 Participants
Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)
|
C-Brace
n=77 Participants
Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.
C-Brace: The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint.
|
|---|---|---|---|
|
Medical Outcomes Study Short Form (SF-36)
Health Change
|
47.4 score on a scale
Standard Deviation 24.2
|
48.0 score on a scale
Standard Deviation 26.0
|
56.5 score on a scale
Standard Deviation 26.4
|
|
Medical Outcomes Study Short Form (SF-36)
Pain
|
55.6 score on a scale
Standard Deviation 25.3
|
57.4 score on a scale
Standard Deviation 24.9
|
59.5 score on a scale
Standard Deviation 26.7
|
|
Medical Outcomes Study Short Form (SF-36)
Physical Functioning
|
29.7 score on a scale
Standard Deviation 22.6
|
31.1 score on a scale
Standard Deviation 23.8
|
44.3 score on a scale
Standard Deviation 23.3
|
|
Medical Outcomes Study Short Form (SF-36)
Role limitations due to emotional problems
|
78.1 score on a scale
Standard Deviation 36.9
|
82.2 score on a scale
Standard Deviation 34.3
|
86.1 score on a scale
Standard Deviation 28.8
|
|
Medical Outcomes Study Short Form (SF-36)
Role limitations due to physical health
|
36.5 score on a scale
Standard Deviation 39.7
|
44.9 score on a scale
Standard Deviation 43.2
|
51.0 score on a scale
Standard Deviation 41.2
|
|
Medical Outcomes Study Short Form (SF-36)
Social Functioning
|
74.2 score on a scale
Standard Deviation 23.0
|
75.1 score on a scale
Standard Deviation 25.0
|
77.3 score on a scale
Standard Deviation 24.4
|
|
Medical Outcomes Study Short Form (SF-36)
Emotional Wellbeing
|
76.2 score on a scale
Standard Deviation 16.4
|
75.5 score on a scale
Standard Deviation 16.3
|
79.2 score on a scale
Standard Deviation 15.16
|
|
Medical Outcomes Study Short Form (SF-36)
Energy/Fatigue
|
52.2 score on a scale
Standard Deviation 21.3
|
52.3 score on a scale
Standard Deviation 20.3
|
56.8 score on a scale
Standard Deviation 20.1
|
|
Medical Outcomes Study Short Form (SF-36)
General Health
|
54.1 score on a scale
Standard Deviation 22.2
|
54.2 score on a scale
Standard Deviation 23.8
|
58.2 score on a scale
Standard Deviation 23.8
|
SECONDARY outcome
Timeframe: Baseline, 3 months after initial home use period, and 3 months after cross-over home use periodPopulation: Intention to Treat Group. If one or more items in a subscale were not answered, the patient was excluded from the analysis of that particular subscale.
12-item instrument used to assess satisfaction with a specific assistive device. Each questions is rated on a 5-point scale, with 1=not satisfied at all and 5=very satisfied. The first 8 questions comprise the Device subscale and the last 4, the Services subscale. Each subscale and the total score are presented as averages ranging from 1 to 5, with higher scores representing greater satisfaction.
Outcome measures
| Measure |
Baseline
n=98 Participants
Baseline measure with currently worn knee ankle foot orthosis (KAFO) or stance control orthosis (SCO)
|
KAFO
n=87 Participants
Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)
|
C-Brace
n=76 Participants
Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.
C-Brace: The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint.
|
|---|---|---|---|
|
Quebec User Evaluation on Satisfaction With Assistive Technology (QUEST)
Device
|
4.05 score on a scale
Standard Deviation 0.67
|
4.05 score on a scale
Standard Deviation 0.72
|
4.00 score on a scale
Standard Deviation 0.63
|
|
Quebec User Evaluation on Satisfaction With Assistive Technology (QUEST)
Service
|
4.60 score on a scale
Standard Deviation 0.64
|
4.66 score on a scale
Standard Deviation 0.70
|
4.79 score on a scale
Standard Deviation 0.42
|
|
Quebec User Evaluation on Satisfaction With Assistive Technology (QUEST)
Total
|
4.23 score on a scale
Standard Deviation 0.59
|
4.27 score on a scale
Standard Deviation 0.64
|
4.27 score on a scale
Standard Deviation 0.49
|
SECONDARY outcome
Timeframe: 3 months after cross-over home use periodPopulation: Subjects that answered the patient-reported outcome questions after having completed home-use periods with both KAFO/SCO and C-Brace (at Visit 2). 75 subjects provided answers to these questions.
Two questions asking how the specific orthoses affected activities they enjoy and their quality of life. Each question is on a 5-point scale, with 1=much worse and 5=much better.
Outcome measures
| Measure |
Baseline
n=35 Participants
Baseline measure with currently worn knee ankle foot orthosis (KAFO) or stance control orthosis (SCO)
|
KAFO
n=40 Participants
Measure at end of 3-month home use period with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO)
|
C-Brace
Measure at the end of the 3-month home-use period with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.
C-Brace: The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint.
|
|---|---|---|---|
|
Patient-Related Outcome Questions
To what extent has the C-Brace impacted your quality of life?
|
4 units on a scale
Interval 3.0 to 4.5
|
4 units on a scale
Interval 4.0 to 5.0
|
—
|
|
Patient-Related Outcome Questions
To what extent has the C-Brace enabled you to engage in the activities that you enjoy?
|
4 units on a scale
Interval 3.0 to 4.0
|
4 units on a scale
Interval 3.75 to 5.0
|
—
|
Adverse Events
KAFO/SCO
Serious events: 10 serious events
Other events: 66 other events
Deaths: 0 deaths
C-Brace
Serious events: 6 serious events
Other events: 57 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
KAFO/SCO
n=102 participants at risk
Home use of 3 months with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO). May also include a period of time when the C-Brace was being fabricated prior to the C-Brace home use of 3 months.
KAFO/SCO: Current knee ankle foot orthosis that the subject was wearing at baseline
|
C-Brace
n=88 participants at risk
Home use of 3 months with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.
C-Brace: The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint.
|
|---|---|---|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/102 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
1.1%
1/88 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
General disorders
Chest Pain
|
0.98%
1/102 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
1.1%
1/88 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Hepatobiliary disorders
Cholecystolithiasis
|
0.98%
1/102 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
0.00%
0/88 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Infections and infestations
COVID-19
|
0.98%
1/102 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
0.00%
0/88 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/102 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
1.1%
1/88 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.98%
1/102 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
0.00%
0/88 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.98%
1/102 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
0.00%
0/88 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Nervous system disorders
Dizziness
|
0.98%
1/102 • Number of events 2 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
0.00%
0/88 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Nervous system disorders
Syncope
|
0.00%
0/102 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
1.1%
1/88 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Reproductive system and breast disorders
Prostate cancer
|
0.00%
0/57 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
2.2%
1/46 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.98%
1/102 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
0.00%
0/88 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.98%
1/102 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
0.00%
0/88 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Skin and subcutaneous tissue disorders
Systemic scleroderma
|
0.98%
1/102 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
0.00%
0/88 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Surgical and medical procedures
Hand operation
|
0.98%
1/102 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
0.00%
0/88 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.98%
1/102 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
1.1%
1/88 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Vascular disorders
Stroke
|
0.98%
1/102 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
0.00%
0/88 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
Other adverse events
| Measure |
KAFO/SCO
n=102 participants at risk
Home use of 3 months with existing knee ankle foot orthosis (KAFO) or existing stance control orthosis (SCO). May also include a period of time when the C-Brace was being fabricated prior to the C-Brace home use of 3 months.
KAFO/SCO: Current knee ankle foot orthosis that the subject was wearing at baseline
|
C-Brace
n=88 participants at risk
Home use of 3 months with newly fitted C-Brace microprocessor-controlled stance and swing control orthosis.
C-Brace: The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint.
|
|---|---|---|
|
Gastrointestinal disorders
Food poisoning
|
0.98%
1/102 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
0.00%
0/88 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/102 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
1.1%
1/88 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Gastrointestinal disorders
Indigestion
|
2.0%
2/102 • Number of events 2 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
0.00%
0/88 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/102 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
1.1%
1/88 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Gastrointestinal disorders
Toothache
|
0.98%
1/102 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
0.00%
0/88 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
General disorders
Increased fall frequency
|
5.9%
6/102 • Number of events 7 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
1.1%
1/88 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
General disorders
Swelling of legs
|
0.98%
1/102 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
0.00%
0/88 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Hepatobiliary disorders
Cystitis
|
2.0%
2/102 • Number of events 2 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
0.00%
0/88 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Immune system disorders
Immunodeficiency syndromes
|
0.98%
1/102 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
0.00%
0/88 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Immune system disorders
Multiple sclerosis aggravated
|
2.0%
2/102 • Number of events 2 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
1.1%
1/88 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Immune system disorders
Psoriasis
|
0.98%
1/102 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
0.00%
0/88 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Infections and infestations
COVID-19
|
2.0%
2/102 • Number of events 2 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
4.5%
4/88 • Number of events 5 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Infections and infestations
Candida infection
|
0.00%
0/102 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
1.1%
1/88 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Infections and infestations
Cold symptoms
|
4.9%
5/102 • Number of events 5 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
3.4%
3/88 • Number of events 3 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Infections and infestations
Ear infection
|
0.00%
0/102 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
1.1%
1/88 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Infections and infestations
Flu
|
0.00%
0/102 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
1.1%
1/88 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Infections and infestations
Klebsiella Infection
|
0.00%
0/102 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
1.1%
1/88 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Infections and infestations
Stomach Virus
|
2.9%
3/102 • Number of events 3 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
1.1%
1/88 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Injury, poisoning and procedural complications
Injurious Fall
|
20.6%
21/102 • Number of events 37 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
11.4%
10/88 • Number of events 15 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Injury, poisoning and procedural complications
Open Wound
|
0.00%
0/102 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
2.3%
2/88 • Number of events 2 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/102 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
1.1%
1/88 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Musculoskeletal and connective tissue disorders
Ankle sprain
|
0.98%
1/102 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
0.00%
0/88 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
7.8%
8/102 • Number of events 8 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
8.0%
7/88 • Number of events 7 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Musculoskeletal and connective tissue disorders
Fibula Fracture
|
0.00%
0/102 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
1.1%
1/88 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Musculoskeletal and connective tissue disorders
Foot Fracture
|
0.00%
0/102 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
1.1%
1/88 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.98%
1/102 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
2.3%
2/88 • Number of events 2 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Musculoskeletal and connective tissue disorders
Juvenile idiopathic arthritis
|
0.98%
1/102 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
1.1%
1/88 • Number of events 2 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Musculoskeletal and connective tissue disorders
Leg Cramps
|
0.98%
1/102 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
1.1%
1/88 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Musculoskeletal and connective tissue disorders
Muscle Pain
|
0.00%
0/102 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
1.1%
1/88 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.98%
1/102 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
1.1%
1/88 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.98%
1/102 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
0.00%
0/88 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/102 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
1.1%
1/88 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Musculoskeletal and connective tissue disorders
Pain in foot
|
2.9%
3/102 • Number of events 3 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
6.8%
6/88 • Number of events 7 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Musculoskeletal and connective tissue disorders
Pain in hip
|
0.98%
1/102 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
3.4%
3/88 • Number of events 3 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Musculoskeletal and connective tissue disorders
Pain in leg
|
7.8%
8/102 • Number of events 8 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
9.1%
8/88 • Number of events 9 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Musculoskeletal and connective tissue disorders
Pain in toe
|
2.0%
2/102 • Number of events 2 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
0.00%
0/88 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Musculoskeletal and connective tissue disorders
Patella Fracture
|
0.98%
1/102 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
0.00%
0/88 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Musculoskeletal and connective tissue disorders
Post polio syndrome
|
0.98%
1/102 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
0.00%
0/88 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Musculoskeletal and connective tissue disorders
Shoulder Pain
|
0.98%
1/102 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
2.3%
2/88 • Number of events 2 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.98%
1/102 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
0.00%
0/88 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/102 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
1.1%
1/88 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Nervous system disorders
Dysaesthesia
|
0.98%
1/102 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
0.00%
0/88 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Nervous system disorders
Headache
|
0.98%
1/102 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
1.1%
1/88 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Nervous system disorders
Lumbar spinal stenosis
|
0.00%
0/102 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
2.3%
2/88 • Number of events 2 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Nervous system disorders
Neuralgia
|
0.98%
1/102 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
0.00%
0/88 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Nervous system disorders
Paraesthesia
|
0.98%
1/102 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
0.00%
0/88 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/102 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
1.1%
1/88 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Product Issues
Additional strap necessary
|
0.00%
0/102 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
1.1%
1/88 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Product Issues
Alignment Issue
|
0.00%
0/102 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
2.3%
2/88 • Number of events 2 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Product Issues
Battery holder defect
|
50.0%
1/2 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
—
0/0 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Product Issues
Beeping
|
50.0%
1/2 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
3.4%
3/88 • Number of events 3 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Product Issues
Bluetooth Malfunction
|
0.00%
0/2 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
3.4%
3/88 • Number of events 3 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Product Issues
Broken Spring
|
3.9%
4/102 • Number of events 4 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
0.00%
0/88 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Product Issues
Broken Strap
|
2.9%
3/102 • Number of events 3 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
3.4%
3/88 • Number of events 4 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Product Issues
Broken foot stirrup
|
0.98%
1/102 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
0.00%
0/88 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Product Issues
Charging Malfunction
|
0.00%
0/2 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
4.5%
4/88 • Number of events 4 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Product Issues
Clicking/cracking noises
|
0.00%
0/102 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
2.3%
2/88 • Number of events 2 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Product Issues
Delamination
|
0.00%
0/102 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
1.1%
1/88 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Product Issues
Foot plate fracture
|
0.98%
1/102 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
2.3%
2/88 • Number of events 2 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Product Issues
Insufficient Padding
|
0.00%
0/102 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
1.1%
1/88 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Product Issues
Joint Malfunction
|
6.9%
7/102 • Number of events 7 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
2.3%
2/88 • Number of events 3 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Product Issues
Loose Screw
|
3.9%
4/102 • Number of events 5 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
1.1%
1/88 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Product Issues
Loss of oil
|
0.00%
0/2 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
1.1%
1/88 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Product Issues
Modified foot plate
|
0.98%
1/102 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
0.00%
0/88 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Product Issues
Poor Fit
|
0.98%
1/102 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
0.00%
0/88 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Product Issues
Service Light
|
0.00%
0/2 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
3.4%
3/88 • Number of events 3 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Product Issues
Unexpected mode switch
|
14.3%
1/7 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
4.5%
4/88 • Number of events 4 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Reproductive system and breast disorders
Vaginal bleeding
|
2.2%
1/45 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
0.00%
0/42 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
0.98%
1/102 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
0.00%
0/88 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/102 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
5.7%
5/88 • Number of events 6 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Skin and subcutaneous tissue disorders
Nail bed inflammation
|
0.00%
0/102 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
1.1%
1/88 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Skin and subcutaneous tissue disorders
Skin Abrasion
|
2.9%
3/102 • Number of events 3 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
9.1%
8/88 • Number of events 9 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/102 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
1.1%
1/88 • Number of events 2 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Vascular disorders
Epistaxis
|
0.98%
1/102 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
0.00%
0/88 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Vascular disorders
Hypertension
|
0.98%
1/102 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
0.00%
0/88 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
|
Vascular disorders
Syncope
|
0.98%
1/102 • Number of events 1 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
0.00%
0/88 • For C-Brace, the period of time for adverse events was the 3-month window after the device had been fitted. In addition to the 3-month home use period, for KAFO/SCO there was often an extra month or two, especially for patients randomized to start with C-Brace since it takes time to fabricate the device and adverse events can occur during that waiting period.
For patients with frequent falls or stumbles, an increase in frequency was considered an adverse event and any falls that resulted in an injury were noted individually as adverse events. Seriousness was determined by the consequences of the event as defined in ISO 14155.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place