Trial Outcomes & Findings for Gait Modification Treatments for Knee Pathology (NCT NCT03116230)
NCT ID: NCT03116230
Last Updated: 2021-08-17
Results Overview
Within-subject change (follow-up - baseline) in peak knee flexion moment (%Bodyweight\*Height) with the intervention at 4-week follow-up versus control (without the intervention) at baseline.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
38 participants
Primary outcome timeframe
Baseline and 4 week follow-up
Results posted on
2021-08-17
Participant Flow
Participant milestones
| Measure |
Experimental Treatment A Then B
Subjects will receive two treatments: (1) a non-invasive external Cutaneous Stimulation device placed on the leg of the subject consisting of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback (vibration) to the subject and (2) a commercially-available knee sleeve, separated by a washout period.
Cutaneous Stimulation: A non-invasive external device that will be placed on the leg of the subject. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback to the subject.
Knee Sleeve: Commercially-available Passive Knee Bands.
|
Experimental Treatment B Then A
Subjects will receive two treatments: (1) a commercially-available knee sleeve and (2) a non-invasive external Cutaneous Stimulation device placed on the leg of the subject consisting of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback (vibration) to the subject, separated by a washout period.
Cutaneous Stimulation: A non-invasive external device that will be placed on the leg of the subject. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback to the subject.
Knee Sleeve: Commercially-available knee sleeve.
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|---|---|---|
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Overall Study
STARTED
|
19
|
19
|
|
Overall Study
COMPLETED
|
15
|
17
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gait Modification Treatments for Knee Pathology
Baseline characteristics by cohort
| Measure |
All Participants
n=38 Participants
Subjects received two treatments assigned in random order: (1) a commercially-available knee sleeve and (2) a non-invasive external Cutaneous Stimulation device placed on the leg of the subject consisting of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback (vibration) to the subject, separated by a washout period.
Cutaneous Stimulation: A non-invasive external device that will be placed on the leg of the subject. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback to the subject.
Knee Sleeve: Commercially-available knee sleeve.
|
|---|---|
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Age, Continuous
|
54.3 years
STANDARD_DEVIATION 11.4 • n=99 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
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Region of Enrollment
United States
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38 participants
n=99 Participants
|
|
Peak Knee Flexion Moment (%Bw*Ht)
|
3.14 %Bw*Ht
STANDARD_DEVIATION 1.31 • n=99 Participants
|
|
KOOS Pain
|
66.25 units on a scale
STANDARD_DEVIATION 13.4 • n=99 Participants
|
|
KOOS Symptoms
|
59.8 units on a scale
STANDARD_DEVIATION 15.58 • n=99 Participants
|
|
KOOS Function
|
72.31 units on a scale
STANDARD_DEVIATION 15.98 • n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4 week follow-upPopulation: Participants completing the study protocol.
Within-subject change (follow-up - baseline) in peak knee flexion moment (%Bodyweight\*Height) with the intervention at 4-week follow-up versus control (without the intervention) at baseline.
Outcome measures
| Measure |
Treatment A (Cutaneous Stimulation)
n=32 Participants
Cutaneous Stimulation: A non-invasive external device that will be placed on the leg of the subject. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback to the subject.
|
Treatment B (Knee Sleeve)
n=32 Participants
Knee Sleeve: Commercially-available Passive Knee Bands.
|
|---|---|---|
|
Change in Peak Knee Flexion Moment (%Bw*Ht)
|
0.197 %Bw*Ht
Standard Deviation 0.374
|
0.018 %Bw*Ht
Standard Deviation 0.725
|
SECONDARY outcome
Timeframe: Baseline and 4 week follow-upPopulation: Participants completing the study protocol.
Within-subject change (follow-up - baseline) in pain (KOOS sub-scale) with the intervention at 4-weeks versus control (without the intervention) at baseline. KOOS scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.
Outcome measures
| Measure |
Treatment A (Cutaneous Stimulation)
n=32 Participants
Cutaneous Stimulation: A non-invasive external device that will be placed on the leg of the subject. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback to the subject.
|
Treatment B (Knee Sleeve)
n=32 Participants
Knee Sleeve: Commercially-available Passive Knee Bands.
|
|---|---|---|
|
Change in Pain
|
1.476 units on a scale
Standard Deviation 12.286
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-0.391 units on a scale
Standard Deviation 9.714
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SECONDARY outcome
Timeframe: Baseline and 4 week follow-upPopulation: Participants completing the study protocol.
Within-subject change (follow-up - baseline) in function (KOOS sub-scale) with the intervention at 4-weeks versus control (without the intervention) at baseline. KOOS scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.
Outcome measures
| Measure |
Treatment A (Cutaneous Stimulation)
n=32 Participants
Cutaneous Stimulation: A non-invasive external device that will be placed on the leg of the subject. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback to the subject.
|
Treatment B (Knee Sleeve)
n=32 Participants
Knee Sleeve: Commercially-available Passive Knee Bands.
|
|---|---|---|
|
Change in Function
|
4.48 units on a scale
Standard Deviation 12.56
|
0.64 units on a scale
Standard Deviation 7.903
|
SECONDARY outcome
Timeframe: Baseline and 4-week follow-upPopulation: Participants completing the study protocol.
Within-subject change (follow-up - baseline) in symptoms (KOOS sub-scale) with the intervention at 4-weeks versus control (without the intervention) at baseline. KOOS scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.
Outcome measures
| Measure |
Treatment A (Cutaneous Stimulation)
n=32 Participants
Cutaneous Stimulation: A non-invasive external device that will be placed on the leg of the subject. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback to the subject.
|
Treatment B (Knee Sleeve)
n=32 Participants
Knee Sleeve: Commercially-available Passive Knee Bands.
|
|---|---|---|
|
Change in Symptoms
|
3.571 units on a scale
Standard Deviation 9.47
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-0.781 units on a scale
Standard Deviation 10.876
|
Adverse Events
Treatment A (Cutaneous Stimulation)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Treatment B (Knee Sleeve)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A (Cutaneous Stimulation)
n=32 participants at risk
Cutaneous Stimulation: A non-invasive external device that will be placed on the leg of the subject. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback to the subject.
|
Treatment B (Knee Sleeve)
n=32 participants at risk
Knee Sleeve: Commercially-available Passive Knee Bands.
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|---|---|---|
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Skin and subcutaneous tissue disorders
Skin Irritation
|
6.2%
2/32 • During active study participation, up to 4 weeks for each treatment
|
0.00%
0/32 • During active study participation, up to 4 weeks for each treatment
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place