Trial Outcomes & Findings for Clinical Algorithm for Post-Stroke Gait Training With C-Brace (NCT NCT02892760)
NCT ID: NCT02892760
Last Updated: 2021-11-08
Results Overview
During the 10 Meter Walk Test (10MWT), infrared light emitting diode markers will be attached to bilateral lower extremities. The marker data will be recorded using the Northern Digital Inc (NDI) Optotrak Certus motion capture system. Marker data will be processed using custom Matlab program to determine lower extremity joint excursion. Joint excursion is the range of motion of a particular joint, and the range of motion is reported in degrees. After stroke, one side of the body is affected, and joint excursion for various joint angles (of hip, knee, and ankle) are reported for both sides of the body (affected side of body and unaffected side of body).
COMPLETED
NA
17 participants
week 5
2021-11-08
Participant Flow
Participant milestones
| Measure |
With C-brace
C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
Received Intervention
|
15
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
With C-brace
C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
Clinical Algorithm for Post-Stroke Gait Training With C-Brace
Baseline characteristics by cohort
| Measure |
With C-brace
n=15 Participants
C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
58.5 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: week 5During the 10 Meter Walk Test (10MWT), infrared light emitting diode markers will be attached to bilateral lower extremities. The marker data will be recorded using the Northern Digital Inc (NDI) Optotrak Certus motion capture system. Marker data will be processed using custom Matlab program to determine lower extremity joint excursion. Joint excursion is the range of motion of a particular joint, and the range of motion is reported in degrees. After stroke, one side of the body is affected, and joint excursion for various joint angles (of hip, knee, and ankle) are reported for both sides of the body (affected side of body and unaffected side of body).
Outcome measures
| Measure |
With C-brace
n=11 Participants
C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
|
|---|---|
|
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
Affected Knee internal-external rotation
|
16.26 degrees
Standard Deviation 9.53
|
|
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
Affected Ankle flexion-extension
|
13.51 degrees
Standard Deviation 7.73
|
|
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
Affected Ankle abduction-adduction
|
6.06 degrees
Standard Deviation 4.33
|
|
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
Affected Hip flexion-extension
|
33.98 degrees
Standard Deviation 10.03
|
|
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
Affected Hip abduction-adduction
|
9.34 degrees
Standard Deviation 3.04
|
|
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
Affected Hip internal-external rotation
|
21.25 degrees
Standard Deviation 14.45
|
|
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
Affected Knee flexion-extension
|
34.51 degrees
Standard Deviation 16.55
|
|
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
Affected Knee abduction-adduction
|
7.72 degrees
Standard Deviation 1.77
|
|
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
Affected Ankle internal-external rotation
|
8.36 degrees
Standard Deviation 7.09
|
|
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
Unaffected Hip flexion-extension
|
45.31 degrees
Standard Deviation 10.21
|
|
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
Unaffected Hip abduction-adduction
|
8.74 degrees
Standard Deviation 3.11
|
|
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
Unaffected Hip internal-external rotation
|
14.82 degrees
Standard Deviation 6.41
|
|
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
Unaffected Knee flexion-extension
|
53.71 degrees
Standard Deviation 7.64
|
|
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
Unaffected Knee abduction-adduction
|
10.30 degrees
Standard Deviation 4.79
|
|
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
Unaffected Knee internal-external rotation
|
11.83 degrees
Standard Deviation 3.11
|
|
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
Unaffected Ankle flexion-extension
|
21.83 degrees
Standard Deviation 6.36
|
|
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
Unaffected Ankle abduction-adduction
|
6.85 degrees
Standard Deviation 1.75
|
|
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
Unaffected Ankle internal-external rotation
|
12.64 degrees
Standard Deviation 4.20
|
PRIMARY outcome
Timeframe: week 9During the 10 Meter Walk Test (10MWT), infrared light emitting diode markers will be attached to bilateral lower extremities. The marker data will be recorded using the NDI Optotrak Certus motion capture system. Marker data will be processed using custom Matlab program to determine lower extremity joint excursion. Joint excursion is the range of motion of a particular joint, and the range of motion is reported in degrees. After stroke, one side of the body is affected, and joint excursion for various joint angles (of hip, knee, and ankle) are reported for both sides of the body (affected side of body and unaffected side of body).
Outcome measures
| Measure |
With C-brace
n=11 Participants
C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
|
|---|---|
|
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
Affected Ankle internal-external rotation
|
7.55 degrees
Standard Deviation 6.01
|
|
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
Affected Hip flexion-extension
|
38.80 degrees
Standard Deviation 11.26
|
|
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
Unaffected Hip flexion-extension
|
46.20 degrees
Standard Deviation 10.79
|
|
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
Unaffected Hip abduction-adduction
|
9.86 degrees
Standard Deviation 3.34
|
|
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
Unaffected Hip internal-external rotation
|
14.99 degrees
Standard Deviation 5.25
|
|
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
Unaffected Knee flexion-extension
|
55.55 degrees
Standard Deviation 7.64
|
|
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
Unaffected Knee abduction-adduction
|
12.06 degrees
Standard Deviation 5.83
|
|
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
Unaffected Knee internal-external rotation
|
12.78 degrees
Standard Deviation 4.32
|
|
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
Unaffected Ankle flexion-extension
|
21.88 degrees
Standard Deviation 4.78
|
|
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
Unaffected Ankle abduction-adduction
|
7.85 degrees
Standard Deviation 2.17
|
|
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
Unaffected Ankle internal-external rotation
|
13.16 degrees
Standard Deviation 5.42
|
|
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
Affected Hip abduction-adduction
|
9.03 degrees
Standard Deviation 3.55
|
|
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
Affected Hip internal-external rotation
|
22.75 degrees
Standard Deviation 15.71
|
|
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
Affected Knee flexion-extension
|
34.93 degrees
Standard Deviation 17.02
|
|
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
Affected Knee abduction-adduction
|
7.92 degrees
Standard Deviation 2.93
|
|
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
Affected Knee internal-external rotation
|
16.18 degrees
Standard Deviation 7.71
|
|
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
Affected Ankle flexion-extension
|
15.91 degrees
Standard Deviation 6.82
|
|
Gait Quality as Indicated by Joint Excursion as Assessed by Kinematic Analysis
Affected Ankle abduction-adduction
|
6.82 degrees
Standard Deviation 5.51
|
PRIMARY outcome
Timeframe: week 5Bipolar surface electrodes will be placed on the bilateral major leg muscles to record electromyography (1000Hz, Motion Labs 16-Channel EMG System). The EMG amplitude (in volts) will be calculated over the whole gait cycle during the 10 Meter Walk Test (10MWT), in which the participant walks 10 meters. After stroke, one side of the body is affected, and data for various muscles are reported for both sides of the body (affected side of body and unaffected side of body).
Outcome measures
| Measure |
With C-brace
n=11 Participants
C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
|
|---|---|
|
Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)
Unaffected Semimembranous
|
0.2835 volts
Standard Deviation 0.0895
|
|
Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)
Affected Tibialis anterior
|
0.2627 volts
Standard Deviation 0.0914
|
|
Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)
Affected Soleus
|
0.2484 volts
Standard Deviation 0.0641
|
|
Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)
Affected Medial gastrocnemius
|
0.2183 volts
Standard Deviation 0.1011
|
|
Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)
Affected Vastus medialis
|
0.2211 volts
Standard Deviation 0.0837
|
|
Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)
Affected Rectus femoris
|
0.2513 volts
Standard Deviation 0.0607
|
|
Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)
Affected Biceps femoris
|
0.3136 volts
Standard Deviation 0.0723
|
|
Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)
Affected Semimembranous
|
0.2184 volts
Standard Deviation 0.0734
|
|
Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)
Unaffected Tibialis anterior
|
0.2791 volts
Standard Deviation 0.0595
|
|
Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)
Unaffected Soleus
|
0.3095 volts
Standard Deviation 0.0574
|
|
Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)
Unaffected Medial gastrocnemius
|
0.2322 volts
Standard Deviation 0.0898
|
|
Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)
Unaffected Vastus medialis
|
0.2508 volts
Standard Deviation 0.0827
|
|
Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)
Unaffected Rectus femoris
|
0.2827 volts
Standard Deviation 0.0873
|
|
Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)
Unaffected Biceps femoris
|
0.2654 volts
Standard Deviation 0.0912
|
PRIMARY outcome
Timeframe: week 9Bipolar surface electrodes will be placed on the bilateral major leg muscles to record electromyography (1000Hz, Motion Labs 16-Channel EMG System). The EMG amplitude (in volts) will be calculated over the whole gait cycle during the 10 Meter Walk Test (10MWT), in which the participant walks 10 meters. After stroke, one side of the body is affected, and data for various muscles are reported for both sides of the body (affected side of body and unaffected side of body).
Outcome measures
| Measure |
With C-brace
n=11 Participants
C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
|
|---|---|
|
Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)
Affected Tibialis anterior
|
0.2639 volts
Standard Deviation 0.0897
|
|
Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)
Affected Soleus
|
0.2776 volts
Standard Deviation 0.0755
|
|
Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)
Affected Medial gastrocnemius
|
0.3312 volts
Standard Deviation 0.0950
|
|
Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)
Affected Vastus medialis
|
0.2149 volts
Standard Deviation 0.1062
|
|
Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)
Affected Rectus femoris
|
0.2146 volts
Standard Deviation 0.1072
|
|
Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)
Affected Biceps femoris
|
0.2795 volts
Standard Deviation 0.0905
|
|
Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)
Affected Semimembranous
|
0.2781 volts
Standard Deviation 0.1045
|
|
Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)
Unaffected Tibialis anterior
|
0.3152 volts
Standard Deviation 0.0689
|
|
Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)
Unaffected Soleus
|
0.3057 volts
Standard Deviation 0.0649
|
|
Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)
Unaffected Medial gastrocnemius
|
0.2598 volts
Standard Deviation 0.0767
|
|
Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)
Unaffected Vastus medialis
|
0.2770 volts
Standard Deviation 0.0812
|
|
Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)
Unaffected Rectus femoris
|
0.2754 volts
Standard Deviation 0.0880
|
|
Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)
Unaffected Biceps femoris
|
0.3026 volts
Standard Deviation 0.1161
|
|
Change in Muscle Function as Indicated by EMG Amplitude Assessed by Surface Electromyography (sEMG)
Unaffected Semimembranous
|
0.2877 volts
Standard Deviation 0.1002
|
PRIMARY outcome
Timeframe: week 5Population: Data were not collected for 2 participants.
Change in metabolic expenditure during walking will be indicated by energy expenditure. Energy Expenditure will be measured by the K4 b2 Cosmed as follows: Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight. Oxygen consumption will be collected on a breath-by-breath basis measured by a portable metabolic system (K4 b2 Cosmed). Prior to the testing, the system will be calibrated using room air and reference gas mixture. During the testing, the subject will wear a face mask and a heart rate monitor at all times and will be asked to breathe normally.
Outcome measures
| Measure |
With C-brace
n=12 Participants
C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
|
|---|---|
|
Metabolic Expenditure During Walking
|
0.03 millilters/kilogram/minute (mL/kg/min)
Standard Deviation 0.02
|
PRIMARY outcome
Timeframe: week 9Population: Data were not collected for 2 participants.
Change in metabolic expenditure during walking will be indicated by energy expenditure. Energy Expenditure will be measured by the K4 b2 Cosmed as follows: Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight. Oxygen consumption will be collected on a breath-by-breath basis measured by a portable metabolic system (K4 b2 Cosmed). Prior to the testing, the system will be calibrated using room air and reference gas mixture. During the testing, the subject will wear a face mask and a heart rate monitor at all times and will be asked to breathe normally.
Outcome measures
| Measure |
With C-brace
n=12 Participants
C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
|
|---|---|
|
Metabolic Expenditure During Walking
|
0.03 millilters/kilogram/minute (mL/kg/min
Standard Deviation 0.01
|
SECONDARY outcome
Timeframe: week 0Population: Data were not collected for 3 participants.
Assesses mobility, balance, walking ability, and fall risk in older adults. The test measures the time it takes the subject to perform a sit to stand from a chair with arms, walk to a mark on the ground 10 feet away and return to the seated position in the chair with arms. This test has been used in assessing stroke recovery with high reliability and validity.
Outcome measures
| Measure |
With C-brace
n=11 Participants
C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
|
|---|---|
|
Score on the Timed Up and Go Test
|
20.09 seconds
Standard Deviation 12.38
|
SECONDARY outcome
Timeframe: week 5Assesses mobility, balance, walking ability, and fall risk in older adults. The test measures the time it takes the subject to perform a sit to stand from a chair with arms, walk to a mark on the ground 10 feet away and return to the seated position in the chair with arms. This test has been used in assessing stroke recovery with high reliability and validity.
Outcome measures
| Measure |
With C-brace
n=14 Participants
C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
|
|---|---|
|
Score on the Timed Up and Go Test
|
19.37 seconds
Standard Deviation 9.13
|
SECONDARY outcome
Timeframe: week 9Assesses mobility, balance, walking ability, and fall risk in older adults. The test measures the time it takes the subject to perform a sit to stand from a chair with arms, walk to a mark on the ground 10 feet away and return to the seated position in the chair with arms. This test has been used in assessing stroke recovery with high reliability and validity.
Outcome measures
| Measure |
With C-brace
n=14 Participants
C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
|
|---|---|
|
Score on the Timed Up and Go Test
|
19.09 seconds
Standard Deviation 9.75
|
SECONDARY outcome
Timeframe: week 0Mini Mental State Examination provides information about orientation, attention, learning, calculation, delayed recall, and construction. Several studies report acceptable validity of MMSE as a screening instrument and its relationship to functional outcome in stroke population. Total score ranges from 0 to 30, with a higher score indicating a better outcome.
Outcome measures
| Measure |
With C-brace
n=14 Participants
C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
|
|---|---|
|
Mental State as Assessed by the Folstein Mini Mental State Examination (MMSE)
|
28.50 score on a scale
Standard Deviation 2.14
|
SECONDARY outcome
Timeframe: week 9Mini Mental State Examination provides information about orientation, attention, learning, calculation, delayed recall, and construction. Several studies report acceptable validity of MMSE as a screening instrument and its relationship to functional outcome in stroke population. Total score ranges from 0 to 30, with a higher score indicating a better outcome.
Outcome measures
| Measure |
With C-brace
n=14 Participants
C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
|
|---|---|
|
Mental State as Assessed by the Folstein Mini Mental State Examination (MMSE)
|
28.43 score on a scale
Standard Deviation 2.65
|
SECONDARY outcome
Timeframe: week 0, week 9Population: Data for this outcome measure were not collected for any participant.
Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as hip flexors.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 0, week 9Population: Data for this outcome measure were not collected for any participant.
Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as hip extensors.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 0, week 9Population: Data for this outcome measure were not collected for any participant.
Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as hip abductors.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 0, week 9Population: Data for this outcome measure were not collected for any participant.
Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as hip adductors.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 0, week 9Population: Data for this outcome measure were not collected for any participant.
Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as knee flexors.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 0, week 9Population: Data for this outcome measure were not collected for any participant.
Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as knee extensors.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 0, week 9Population: Data for this outcome measure were not collected for any participant.
Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as ankle dorsiflexors.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 0, week 9Population: Data for this outcome measure were not collected for any participant.
Muscle strength will be measured and quantified by using dynamometers on major bilateral lower limb muscles such as ankle plantarflexors.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 0Range of motion will be measured on bilateral hip using goniometry (goniometry is the use of a device called a goniometer to measure range of motion of a joint in degrees). After stroke, one side of the body is affected. For each participant, the range of motion of their affected hip will be measured and also the range of motion of their other hip (the unaffected hip) will be measured \[it is possible that a participant will have a range of motion within normal limits on both hip sides (affected hip and unaffected hip)\].
Outcome measures
| Measure |
With C-brace
n=14 Participants
C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
|
|---|---|
|
Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by Goniometry
Unaffected side hip internal rotation
|
13 Participants
|
|
Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by Goniometry
Unaffected side hip external rotation
|
13 Participants
|
|
Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by Goniometry
Unaffected side hip abduction
|
14 Participants
|
|
Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by Goniometry
Unaffected side hip adduction
|
14 Participants
|
|
Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by Goniometry
Affected side hip flexion
|
12 Participants
|
|
Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by Goniometry
Affected side hip extension
|
11 Participants
|
|
Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by Goniometry
Affected side hip internal rotation
|
13 Participants
|
|
Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by Goniometry
Affected side hip external rotation
|
13 Participants
|
|
Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by Goniometry
Affected side hip abduction
|
12 Participants
|
|
Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by Goniometry
Affected side hip adduction
|
14 Participants
|
|
Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by Goniometry
Unaffected side hip flexion
|
13 Participants
|
|
Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by Goniometry
Unaffected side hip extension
|
13 Participants
|
SECONDARY outcome
Timeframe: week 9Range of motion will be measured on bilateral hip using goniometry (goniometry is the use of a device called a goniometer to measure range of motion of a joint in degrees). After stroke, one side of the body is affected. For each participant, the range of motion of their affected hip will be measured and also the range of motion of their other hip (the unaffected hip) will be measured \[it is possible that a participant will have a range of motion within normal limits on both hip sides (affected hip and unaffected hip)\].
Outcome measures
| Measure |
With C-brace
n=14 Participants
C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
|
|---|---|
|
Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by Goniometry
Unaffected side hip internal rotation
|
14 Participants
|
|
Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by Goniometry
Affected side hip flexion
|
13 Participants
|
|
Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by Goniometry
Affected side hip extension
|
11 Participants
|
|
Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by Goniometry
Affected side hip internal rotation
|
12 Participants
|
|
Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by Goniometry
Affected side hip external rotation
|
11 Participants
|
|
Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by Goniometry
Affected side hip abduction
|
13 Participants
|
|
Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by Goniometry
Affected side hip adduction
|
14 Participants
|
|
Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by Goniometry
Unaffected side hip flexion
|
14 Participants
|
|
Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by Goniometry
Unaffected side hip extension
|
13 Participants
|
|
Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by Goniometry
Unaffected side hip external rotation
|
14 Participants
|
|
Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by Goniometry
Unaffected side hip abduction
|
14 Participants
|
|
Number of Participants With Bilateral Hip Range of Motion Within Normal Limits as Assessed by Goniometry
Unaffected side hip adduction
|
14 Participants
|
SECONDARY outcome
Timeframe: week 0Range of motion will be measured on knee joints using goniometry (goniometry is the use of a device called a goniometer to measure range of motion of a joint in degrees). After stroke, one side of the body is affected. For each participant, the range of motion of their affected knee will be measured and also the range of motion of their other knee (the unaffected knee) will be measured \[it is possible that a participant will have a range of motion within normal limits for both knees (affected knee and unaffected knee)\].
Outcome measures
| Measure |
With C-brace
n=14 Participants
C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
|
|---|---|
|
Number of Participants With Knee Joint Range of Motion Within Normal Limits as Assessed by Goniometry
Affected side knee flexion
|
11 Participants
|
|
Number of Participants With Knee Joint Range of Motion Within Normal Limits as Assessed by Goniometry
Affected side knee extension
|
12 Participants
|
|
Number of Participants With Knee Joint Range of Motion Within Normal Limits as Assessed by Goniometry
Unaffected side knee flexion
|
13 Participants
|
|
Number of Participants With Knee Joint Range of Motion Within Normal Limits as Assessed by Goniometry
Unaffected side knee extension
|
12 Participants
|
SECONDARY outcome
Timeframe: week 9Range of motion will be measured on knee joints using goniometry (goniometry is the use of a device called a goniometer to measure range of motion of a joint in degrees). After stroke, one side of the body is affected. For each participant, the range of motion of their affected knee will be measured and also the range of motion of their other knee (the unaffected knee) will be measured \[it is possible that a participant will have a range of motion within normal limits for both knees (affected knee and unaffected knee)\].
Outcome measures
| Measure |
With C-brace
n=14 Participants
C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
|
|---|---|
|
Number of Participants With Knee Joint Range of Motion Within Normal Limits as Assessed by Goniometry
Affected side knee flexion
|
12 Participants
|
|
Number of Participants With Knee Joint Range of Motion Within Normal Limits as Assessed by Goniometry
Affected side knee extension
|
14 Participants
|
|
Number of Participants With Knee Joint Range of Motion Within Normal Limits as Assessed by Goniometry
Unaffected side knee flexion
|
14 Participants
|
|
Number of Participants With Knee Joint Range of Motion Within Normal Limits as Assessed by Goniometry
Unaffected side knee extension
|
14 Participants
|
SECONDARY outcome
Timeframe: week 0Range of motion will be measured on ankle joints using goniometry (goniometry is the use of a device called a goniometer to measure range of motion of a joint in degrees). After stroke, one side of the body is affected. For each participant, the range of motion of their affected ankle will be measured and also the range of motion of their other ankle (the unaffected ankle) will be measured \[it is possible that a participant will have a range of motion within normal limits for both ankles (affected ankle and unaffected ankle)\].
Outcome measures
| Measure |
With C-brace
n=14 Participants
C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
|
|---|---|
|
Number of Participants With Ankle Joint Range of Motion Within Normal Limits as Assessed by Goniometry
Affected side ankle dorsiflexion
|
4 Participants
|
|
Number of Participants With Ankle Joint Range of Motion Within Normal Limits as Assessed by Goniometry
Affected side ankle plantarflexion
|
13 Participants
|
|
Number of Participants With Ankle Joint Range of Motion Within Normal Limits as Assessed by Goniometry
Unaffected side ankle dorsiflexion
|
13 Participants
|
|
Number of Participants With Ankle Joint Range of Motion Within Normal Limits as Assessed by Goniometry
Unaffected side ankle plantarflexion
|
14 Participants
|
SECONDARY outcome
Timeframe: week 9Range of motion will be measured on ankle joints using goniometry (goniometry is the use of a device called a goniometer to measure range of motion of a joint in degrees). After stroke, one side of the body is affected. For each participant, the range of motion of their affected ankle will be measured and also the range of motion of their other ankle (the unaffected ankle) will be measured \[it is possible that a participant will have a range of motion within normal limits for both ankles (affected ankle and unaffected ankle)\].
Outcome measures
| Measure |
With C-brace
n=14 Participants
C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
|
|---|---|
|
Number of Participants With Ankle Joint Range of Motion Within Normal Limits as Assessed by Goniometry
Affected side ankle dorsiflexion
|
6 Participants
|
|
Number of Participants With Ankle Joint Range of Motion Within Normal Limits as Assessed by Goniometry
Affected side ankle plantarflexion
|
12 Participants
|
|
Number of Participants With Ankle Joint Range of Motion Within Normal Limits as Assessed by Goniometry
Unaffected side ankle dorsiflexion
|
14 Participants
|
|
Number of Participants With Ankle Joint Range of Motion Within Normal Limits as Assessed by Goniometry
Unaffected side ankle plantarflexion
|
14 Participants
|
SECONDARY outcome
Timeframe: week 0The Fugl-Meyer Assessment evaluates and measures recovery of movement in individual post stroke. The Fugl-Meyer has been used in both clinical and research settings and is one of the most widely used quantitative measures of motor impairment. It uses an ordinal scale for scoring of 17 items for the lower limb component and 7 items on the balance component, for a total of 24 items. Each of the 24 items is scored as 0 (cannot perform), 1 (can perform partially), or 2 (can perform fully), with a total score ranging from 0 to 48, with a higher score indicating less impairment.
Outcome measures
| Measure |
With C-brace
n=14 Participants
C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
|
|---|---|
|
Motor Impairment as Determined by the Fugl-Meyer Assessment
|
23.43 score on a scale
Standard Deviation 4.52
|
SECONDARY outcome
Timeframe: week 9The Fugl-Meyer Assessment evaluates and measures recovery of movement in individual post stroke. The Fugl-Meyer has been used in both clinical and research settings and is one of the most widely used quantitative measures of motor impairment. It uses an ordinal scale for scoring of 17 items for the lower limb component and 7 items on the balance component, for a total of 24 items. Each of the 24 items is scored as 0 (cannot perform), 1 (can perform partially), or 2 (can perform fully), with a total score ranging from 0 to 48, with a higher score indicating less impairment.
Outcome measures
| Measure |
With C-brace
n=14 Participants
C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
|
|---|---|
|
Motor Impairment as Determined by the Fugl-Meyer Assessment
|
24.29 score on a scale
Standard Deviation 5.27
|
SECONDARY outcome
Timeframe: week 0This test measures spasticity in patients with lesions of the Central Nervous System by testing resistance to passive movement about a joint with varying degrees of velocity. Scores range from 0-4, with 0 indicating normal muscle tone and 4 indicating very high spasticity. The investigators will measure spasticity in lower limbs.
Outcome measures
| Measure |
With C-brace
n=14 Participants
C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
|
|---|---|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
Affected side hip flexor
|
0 score on a scale
Standard Deviation 0
|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
Affected side hip extensor
|
0.07 score on a scale
Standard Deviation 0.27
|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
Affected side knee flexors
|
0.07 score on a scale
Standard Deviation 0.27
|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
Affected side knee extensors
|
0.5 score on a scale
Standard Deviation 0.76
|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
Affected side ankle dorsiflexors
|
0.21 score on a scale
Standard Deviation 0.8
|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
Affected side ankle plantarflexors
|
0.71 score on a scale
Standard Deviation 0.97
|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
Unaffected side hip flexor
|
0 score on a scale
Standard Deviation 0
|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
Unaffected side hip extensor
|
0 score on a scale
Standard Deviation 0
|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
Unaffected side knee flexors
|
0 score on a scale
Standard Deviation 0
|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
Unaffected side knee extensors
|
0 score on a scale
Standard Deviation 0
|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
Unaffected side ankle dorsiflexors
|
0 score on a scale
Standard Deviation 0
|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
Unaffected side ankle plantarflexors
|
0 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: week 9This test measures spasticity in patients with lesions of the Central Nervous System by testing resistance to passive movement about a joint with varying degrees of velocity. Scores range from 0-4, with 0 indicating normal muscle tone and 4 indicating very high spasticity. The investigators will measure spasticity in lower limbs.
Outcome measures
| Measure |
With C-brace
n=14 Participants
C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
|
|---|---|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
Affected side hip flexor
|
0.18 score on a scale
Standard Deviation 0.46
|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
Affected side hip extensor
|
0.07 score on a scale
Standard Deviation 0.27
|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
Affected side knee flexors
|
0.32 score on a scale
Standard Deviation 0.54
|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
Affected side knee extensors
|
0.64 score on a scale
Standard Deviation 0.72
|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
Affected side ankle dorsiflexors
|
0 score on a scale
Standard Deviation 0
|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
Affected side ankle plantarflexors
|
0.57 score on a scale
Standard Deviation 0.73
|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
Unaffected side hip flexor
|
0 score on a scale
Standard Deviation 0
|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
Unaffected side hip extensor
|
0 score on a scale
Standard Deviation 0
|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
Unaffected side knee flexors
|
0 score on a scale
Standard Deviation 0
|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
Unaffected side knee extensors
|
0 score on a scale
Standard Deviation 0
|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
Unaffected side ankle dorsiflexors
|
0 score on a scale
Standard Deviation 0
|
|
Spasticity as Assessed by the Modified Ashworth Scale (MAS)
Unaffected side ankle plantarflexors
|
0 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: week 0A 14-item objective measure designed to assess static balance and fall risk in adult populations, with a total score range of 0 to 56 (higher scores represent better functional outcome). This test has been widely used to measure functional recovery in stroke patients with high reliability.
Outcome measures
| Measure |
With C-brace
n=14 Participants
C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
|
|---|---|
|
Static Balance as Assessed by the Berg Balance Scale (BBS)
|
48.64 score on a scale
Standard Deviation 5.17
|
SECONDARY outcome
Timeframe: week 9A 14-item objective measure designed to assess static balance and fall risk in adult populations, with a total score range of 0 to 56 (higher scores represent better functional outcome). This test has been widely used to measure functional recovery in stroke patients with high reliability.
Outcome measures
| Measure |
With C-brace
n=14 Participants
C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
|
|---|---|
|
Static Balance as Assessed by the Berg Balance Scale (BBS)
|
49.79 score on a scale
Standard Deviation 4.51
|
SECONDARY outcome
Timeframe: week 0Measure of gait speed. Subjects will walk a total of 14 meters at their preferred walking speed and at a fast pace. The test measures the time it takes the subject to complete the middle 10 meters of the walk.
Outcome measures
| Measure |
With C-brace
n=14 Participants
C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
|
|---|---|
|
Gait Speed as Assessed by the 10 Meter Walk Test (10MWT)
|
0.65 meters per second
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: week 5Measure of gait speed. Subjects will walk a total of 14 meters at their preferred walking speed and at a fast pace. The test measures the time it takes the subject to complete the middle 10 meters of the walk.
Outcome measures
| Measure |
With C-brace
n=14 Participants
C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
|
|---|---|
|
Gait Speed as Assessed by the 10 Meter Walk Test (10MWT)
|
0.66 meters per second
Standard Deviation 0.31
|
SECONDARY outcome
Timeframe: week 9Measure of gait speed. Subjects will walk a total of 14 meters at their preferred walking speed and at a fast pace. The test measures the time it takes the subject to complete the middle 10 meters of the walk.
Outcome measures
| Measure |
With C-brace
n=14 Participants
C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
|
|---|---|
|
Gait Speed as Assessed by the 10 Meter Walk Test (10MWT)
|
0.73 meters per second
Standard Deviation 0.29
|
SECONDARY outcome
Timeframe: week 0The participant will perform the 6MWT, in which the participant will walk as far as possible in six minutes. During the 6MWT, the peak volume of oxygen consumed per minute (peak VO₂) will be measured by a portable metabolic system. Data are reported as peak volume of oxygen (in milliliters) consumed per kilogram bodyweight per minute per meter walked \[milliliters/kilogram/minute/meter (mL/kg/min/m)\].
Outcome measures
| Measure |
With C-brace
n=14 Participants
C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
|
|---|---|
|
Aerobic Capacity as Assessed by Peak VO₂ Per Kilogram Body Weight During the Six-minute Walk Test (6MWT)
|
0.033 mL/kg/min/m
Standard Deviation 0.015
|
SECONDARY outcome
Timeframe: week 5Population: Data for this outcome measure were not collected for 2 participants.
The participant will perform the 6MWT, in which the participant will walk as far as possible in six minutes. During the 6MWT, the peak volume of oxygen consumed per minute (peak VO₂) will be will be measured by a portable metabolic system. Data are reported as peak volume of oxygen (in milliliters) consumed per kilogram bodyweight per minute per meter walked \[milliliters/kilogram/minute/meter (mL/kg/min/m)\].
Outcome measures
| Measure |
With C-brace
n=12 Participants
C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
|
|---|---|
|
Aerobic Capacity as Assessed by Peak VO₂ Per Kilogram Body Weight During the Six-minute Walk Test (6MWT)
|
0.030 mL/kg/min/m
Standard Deviation 0.015
|
SECONDARY outcome
Timeframe: week 9The participant will perform the 6MWT, in which the participant will walk as far as possible in six minutes. During the 6MWT, the peak volume of oxygen consumed per minute (peak VO₂) will be will be measured by a portable metabolic system. Data are reported as peak volume of oxygen (in milliliters) consumed per kilogram bodyweight per minute per meter walked \[milliliters/kilogram/minute/meter (mL/kg/min/m)\].
Outcome measures
| Measure |
With C-brace
n=14 Participants
C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
|
|---|---|
|
Aerobic Capacity as Assessed by Peak VO₂ Per Kilogram Body Weight During the Six-minute Walk Test (6MWT)
|
0.030 mL/kg/min/m
Standard Deviation 0.013
|
Adverse Events
With C-brace
Serious adverse events
| Measure |
With C-brace
n=15 participants at risk
C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
|
|---|---|
|
Nervous system disorders
Seizure
|
6.7%
1/15 • Number of events 1 • 23 months
2 withdrew before adverse event data was collected.
|
Other adverse events
| Measure |
With C-brace
n=15 participants at risk
C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
|
|---|---|
|
General disorders
Fall at home/office
|
26.7%
4/15 • Number of events 4 • 23 months
2 withdrew before adverse event data was collected.
|
|
Skin and subcutaneous tissue disorders
Skin pinch
|
20.0%
3/15 • Number of events 5 • 23 months
2 withdrew before adverse event data was collected.
|
|
Skin and subcutaneous tissue disorders
Blister
|
6.7%
1/15 • Number of events 2 • 23 months
2 withdrew before adverse event data was collected.
|
|
Skin and subcutaneous tissue disorders
Skin redness
|
6.7%
1/15 • Number of events 1 • 23 months
2 withdrew before adverse event data was collected.
|
|
General disorders
High blood pressure
|
6.7%
1/15 • Number of events 1 • 23 months
2 withdrew before adverse event data was collected.
|
|
Investigations
Device non-function
|
6.7%
1/15 • Number of events 3 • 23 months
2 withdrew before adverse event data was collected.
|
Additional Information
Gerard Francisco, MD
The University of Texas Health Science Center at Houston
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place