Trial Outcomes & Findings for Validation of a Knee Brace for Gonarthrosis (NCT NCT05814471)
NCT ID: NCT05814471
Last Updated: 2025-07-29
Results Overview
The scale was developped for this study. The mesure is an average of 5 items with 5 point scale rating system(1 harder to use; 5 easier to use). Mean score ranges from (1 harder to use; 5 easier to use)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
5 participants
Primary outcome timeframe
Before the 2 weeks of intervention with each brace, assessed after a brace fitting protocol and a few minutes of wearing the intervention brace.
Results posted on
2025-07-29
Participant Flow
Total enrollment was 5 participants, since participants did all interventions in a sequence, the total amount of participants for each intervention was 5 since there were no exclusions nor drop-outs.
Participant milestones
| Measure |
Adjustement Period(Velcro)First, Then Cable Fastening System Then Velcro Straps
A new knee brace is worn for a 14 days adjustement period with velcro straps. Then the brace is worn with a cable fastening system for a first 14 days intervention period, therefore the knee brace is held in place by a cable fastening system and 3d printed straps. The second 14 days intervention period is done with velcro straps keeping the brace in position.
|
Adjustement Period(Velcro)First, Then Velcro Straps Then Cable Fastening System
A new knee brace is worn for a 14 days adjustement period with velcro straps. The first 14 days intervention period is done with velcro straps keeping the brace in position. Then the brace is worn with a cable fastening system for a second 14 days intervention period, therefore the knee brace is held in place by a cable fastening system and 3d printed straps.
|
|---|---|---|
|
Adjustment Period(14 Days)
STARTED
|
3
|
2
|
|
Adjustment Period(14 Days)
COMPLETED
|
3
|
2
|
|
Adjustment Period(14 Days)
NOT COMPLETED
|
0
|
0
|
|
First Intervention(14 Days)
STARTED
|
3
|
2
|
|
First Intervention(14 Days)
COMPLETED
|
3
|
2
|
|
First Intervention(14 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention(14 Days)
STARTED
|
3
|
2
|
|
Second Intervention(14 Days)
COMPLETED
|
3
|
2
|
|
Second Intervention(14 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Validation of a Knee Brace for Gonarthrosis
Baseline characteristics by cohort
| Measure |
All Participants
n=5 Participants
All participants who completed the intervention protocol.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
5 participants
n=5 Participants
|
|
Psychological Symptoms
|
28.0 units on a scale
STANDARD_DEVIATION 27.4 • n=5 Participants
|
|
Physical Symptoms
|
68.9 units on a scale
STANDARD_DEVIATION 23.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: Before the 2 weeks of intervention with each brace, assessed after a brace fitting protocol and a few minutes of wearing the intervention brace.The scale was developped for this study. The mesure is an average of 5 items with 5 point scale rating system(1 harder to use; 5 easier to use). Mean score ranges from (1 harder to use; 5 easier to use)
Outcome measures
| Measure |
Cable Fastening System
n=5 Participants
The knee brace is worn for 2 weeks after adjustment period. The knee brace is held in place by a cable fastening system and 3d printed straps.
Cable fastening system and 3d printed straps: The participants will wear a Odra knee brace held in place with by a cable fastening system and 3d printed straps for 2 weeks.
|
Velcro Straps
n=5 Participants
The knee brace is worn for 2 weeks after adjustment period. The knee brace is held in place by a velcro straps system.
Velcro straps system: The participants will wear a Odra knee brace held in place with by a velcro straps system for 2 weeks.
|
Adjustment Period(Velcro-14 Days)
n=5 Participants
The participants wore a new Odra knee brace held in place with by a velcro straps system for 2 weeks.
|
|---|---|---|---|
|
Ease of Use Measurement Scale
|
4.05 score on a scale
Standard Deviation 0.26
|
3.00 score on a scale
Standard Deviation 1.21
|
4.05 score on a scale
Standard Deviation 0.78
|
PRIMARY outcome
Timeframe: Directly after the 2 weeks of intervention with each brace, assessed after a brace fitting protocol and a few minutes of wearing the intervention brace.The scale was developped for this study. The mesure is an average of 5 items with 5 point scale rating system(1 harder to use; 5 easier to use). Mean score ranges from (1 harder to use; 5 easier to use)
Outcome measures
| Measure |
Cable Fastening System
n=5 Participants
The knee brace is worn for 2 weeks after adjustment period. The knee brace is held in place by a cable fastening system and 3d printed straps.
Cable fastening system and 3d printed straps: The participants will wear a Odra knee brace held in place with by a cable fastening system and 3d printed straps for 2 weeks.
|
Velcro Straps
n=5 Participants
The knee brace is worn for 2 weeks after adjustment period. The knee brace is held in place by a velcro straps system.
Velcro straps system: The participants will wear a Odra knee brace held in place with by a velcro straps system for 2 weeks.
|
Adjustment Period(Velcro-14 Days)
n=5 Participants
The participants wore a new Odra knee brace held in place with by a velcro straps system for 2 weeks.
|
|---|---|---|---|
|
Ease of Use Measurement Scale
|
4.60 score on a scale
Standard Deviation 0.33
|
3.45 score on a scale
Standard Deviation 1.17
|
3.80 score on a scale
Standard Deviation 0.54
|
PRIMARY outcome
Timeframe: Before the 2 weeks of intervention with each brace, assessed after a brace fitting protocol and a few minutes of wearing the intervention brace.The scale was developped for this study. The mesure is an average of 2 items with 5 point scale rating system(1 lowest comfort; 5 highest comfort). Total score is adjusted to 0 (lowest comfort) to 100 (highest comfort).
Outcome measures
| Measure |
Cable Fastening System
n=5 Participants
The knee brace is worn for 2 weeks after adjustment period. The knee brace is held in place by a cable fastening system and 3d printed straps.
Cable fastening system and 3d printed straps: The participants will wear a Odra knee brace held in place with by a cable fastening system and 3d printed straps for 2 weeks.
|
Velcro Straps
n=5 Participants
The knee brace is worn for 2 weeks after adjustment period. The knee brace is held in place by a velcro straps system.
Velcro straps system: The participants will wear a Odra knee brace held in place with by a velcro straps system for 2 weeks.
|
Adjustment Period(Velcro-14 Days)
n=5 Participants
The participants wore a new Odra knee brace held in place with by a velcro straps system for 2 weeks.
|
|---|---|---|---|
|
Comfort Measurement Scale
|
90 score on a scale
Standard Deviation 13.7
|
80 score on a scale
Standard Deviation 20.9
|
62.5 score on a scale
Standard Deviation 20.9
|
PRIMARY outcome
Timeframe: Directly after the 2 weeks of intervention with each brace, assessed after a brace fitting protocol and a few minutes of wearing the intervention brace.The scale was developped for this study. The mesure is an average of 2 items with 5 point scale rating system(1 lowest comfort; 5 highest comfort). Total score is adjusted to 0 (lowest comfort) to 100 (highest comfort).
Outcome measures
| Measure |
Cable Fastening System
n=5 Participants
The knee brace is worn for 2 weeks after adjustment period. The knee brace is held in place by a cable fastening system and 3d printed straps.
Cable fastening system and 3d printed straps: The participants will wear a Odra knee brace held in place with by a cable fastening system and 3d printed straps for 2 weeks.
|
Velcro Straps
n=5 Participants
The knee brace is worn for 2 weeks after adjustment period. The knee brace is held in place by a velcro straps system.
Velcro straps system: The participants will wear a Odra knee brace held in place with by a velcro straps system for 2 weeks.
|
Adjustment Period(Velcro-14 Days)
n=5 Participants
The participants wore a new Odra knee brace held in place with by a velcro straps system for 2 weeks.
|
|---|---|---|---|
|
Comfort Measurement Scale
|
90 score on a scale
Standard Deviation 11.2
|
75 score on a scale
Standard Deviation 30.6
|
77.5 score on a scale
Standard Deviation 16
|
PRIMARY outcome
Timeframe: Change between baseline(directly before adjustment period) and directly after 2 weeks adjustment period.Knee injury and Osteoarthritis Outcome Total Score (KOOS), translated to French(Quebec). Minimum=0(worst symptoms); Maximum=100(no symptoms);
Outcome measures
| Measure |
Cable Fastening System
n=5 Participants
The knee brace is worn for 2 weeks after adjustment period. The knee brace is held in place by a cable fastening system and 3d printed straps.
Cable fastening system and 3d printed straps: The participants will wear a Odra knee brace held in place with by a cable fastening system and 3d printed straps for 2 weeks.
|
Velcro Straps
The knee brace is worn for 2 weeks after adjustment period. The knee brace is held in place by a velcro straps system.
Velcro straps system: The participants will wear a Odra knee brace held in place with by a velcro straps system for 2 weeks.
|
Adjustment Period(Velcro-14 Days)
The participants wore a new Odra knee brace held in place with by a velcro straps system for 2 weeks.
|
|---|---|---|---|
|
Physical Symptoms
|
0.6 score on a scale
Standard Deviation 3.6
|
—
|
—
|
PRIMARY outcome
Timeframe: Change between directly after 2 weeks adjustment period and directly after 2 weeks of use for each armKnee injury and Osteoarthritis Outcome Total Score (KOOS), translated to French(Quebec). Minimum=0(worst symptoms); Maximum=100(no symptoms);
Outcome measures
| Measure |
Cable Fastening System
n=5 Participants
The knee brace is worn for 2 weeks after adjustment period. The knee brace is held in place by a cable fastening system and 3d printed straps.
Cable fastening system and 3d printed straps: The participants will wear a Odra knee brace held in place with by a cable fastening system and 3d printed straps for 2 weeks.
|
Velcro Straps
n=5 Participants
The knee brace is worn for 2 weeks after adjustment period. The knee brace is held in place by a velcro straps system.
Velcro straps system: The participants will wear a Odra knee brace held in place with by a velcro straps system for 2 weeks.
|
Adjustment Period(Velcro-14 Days)
The participants wore a new Odra knee brace held in place with by a velcro straps system for 2 weeks.
|
|---|---|---|---|
|
Physical Symptoms
|
2.0 score on a scale
Standard Deviation 2.3
|
-0.2 score on a scale
Standard Deviation 5.4
|
—
|
PRIMARY outcome
Timeframe: Change between baseline(directly before adjustment period) and directly after 2 weeks adjustment period.Psychological Symptoms Inventory Total Score(Ilfeld, F. W. (1976). Further validation of a psychiatric symptom index in a normal population. Psychological Reports, 39(3, Pt 2), 1215-1228.). Minimum=0; (No symptoms); Maximum=100(Worst Symptoms);
Outcome measures
| Measure |
Cable Fastening System
n=5 Participants
The knee brace is worn for 2 weeks after adjustment period. The knee brace is held in place by a cable fastening system and 3d printed straps.
Cable fastening system and 3d printed straps: The participants will wear a Odra knee brace held in place with by a cable fastening system and 3d printed straps for 2 weeks.
|
Velcro Straps
The knee brace is worn for 2 weeks after adjustment period. The knee brace is held in place by a velcro straps system.
Velcro straps system: The participants will wear a Odra knee brace held in place with by a velcro straps system for 2 weeks.
|
Adjustment Period(Velcro-14 Days)
The participants wore a new Odra knee brace held in place with by a velcro straps system for 2 weeks.
|
|---|---|---|---|
|
Psychological Symptoms
|
-3.4 score on a scale
Standard Deviation 6.5
|
—
|
—
|
PRIMARY outcome
Timeframe: Change between directly after 2 weeks adjustment period and directly after 2 weeks of use for each armPsychological Symptoms Inventory Total Score(Ilfeld, F. W. (1976). Further validation of a psychiatric symptom index in a normal population. Psychological Reports, 39(3, Pt 2), 1215-1228.). Minimum=0; (No symptoms); Maximum=100(Worst Symptoms);
Outcome measures
| Measure |
Cable Fastening System
n=5 Participants
The knee brace is worn for 2 weeks after adjustment period. The knee brace is held in place by a cable fastening system and 3d printed straps.
Cable fastening system and 3d printed straps: The participants will wear a Odra knee brace held in place with by a cable fastening system and 3d printed straps for 2 weeks.
|
Velcro Straps
n=5 Participants
The knee brace is worn for 2 weeks after adjustment period. The knee brace is held in place by a velcro straps system.
Velcro straps system: The participants will wear a Odra knee brace held in place with by a velcro straps system for 2 weeks.
|
Adjustment Period(Velcro-14 Days)
The participants wore a new Odra knee brace held in place with by a velcro straps system for 2 weeks.
|
|---|---|---|---|
|
Psychological Symptoms
|
-7.4 score on a scale
Standard Deviation 6.1
|
-6.7 score on a scale
Standard Deviation 6.1
|
—
|
Adverse Events
Cable Fastening System
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Velcro Straps
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Adjustment Period
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is 1 year from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER