Trial Outcomes & Findings for A 12-Week Home-Based Electrical Stimulation Program for Strength in Adults With Knee Osteoarthritis (NCT NCT05765435)
NCT ID: NCT05765435
Last Updated: 2025-07-03
Results Overview
Strength assessment of the quadriceps muscles using a handheld dynamometer, measured in Newtons. Subjects performed 3 repetitions of maximal effort, separated by two minutes of rest between each. The average of the 3 repetitions was recorded as the subjects' 1 repetition maximum. A positive change indicates increased quadriceps strength.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
Baseline, 6 weeks, 12 weeks
Results posted on
2025-07-03
Participant Flow
Participant milestones
| Measure |
Control
Device: Cionic Neural Sleeve NS-100. Participants will wear the device during the 12-week exercise and walking program. There will be no stimulation.
|
NMES
Device: Cionic Neural Sleeve NS-100. Participants will wear the device during the 12-week exercise and walking program and receive stimulation assistance during the exercise sessions.
|
NMES and FES
Device: Cionic Neural Sleeve NS-100. Participants will wear the device during the 12-week exercise and walking program and receive stimulation assistance during the exercise and walking sessions.
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Control
Device: Cionic Neural Sleeve NS-100. Participants will wear the device during the 12-week exercise and walking program. There will be no stimulation.
|
NMES
Device: Cionic Neural Sleeve NS-100. Participants will wear the device during the 12-week exercise and walking program and receive stimulation assistance during the exercise sessions.
|
NMES and FES
Device: Cionic Neural Sleeve NS-100. Participants will wear the device during the 12-week exercise and walking program and receive stimulation assistance during the exercise and walking sessions.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control
n=2 Participants
Device: Cionic Neural Sleeve NS-100. Participants will wear the device during the 12-week exercise and walking program. There will be no stimulation.
|
NMES
n=1 Participants
Device: Cionic Neural Sleeve NS-100. Participants will wear the device during the 12-week exercise and walking program and receive stimulation assistance during the exercise sessions.
|
NMES and FES
n=1 Participants
Device: Cionic Neural Sleeve NS-100. Participants will wear the device during the 12-week exercise and walking program and receive stimulation assistance during the exercise and walking sessions.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=2 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
4 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=2 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
4 Participants
n=4 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Severity of Knee Osteoarthritis
Mild Severity of the Instrumented Leg
|
2 Participants
n=2 Participants • Two subgroups, mild and moderate ...
|
0 Participants
n=1 Participants • Two subgroups, mild and moderate ...
|
0 Participants
n=1 Participants • Two subgroups, mild and moderate ...
|
2 Participants
n=4 Participants • Two subgroups, mild and moderate ...
|
|
Severity of Knee Osteoarthritis
Moderate Severity of the Instrumented Leg
|
0 Participants
n=2 Participants • Two subgroups, mild and moderate ...
|
1 Participants
n=1 Participants • Two subgroups, mild and moderate ...
|
1 Participants
n=1 Participants • Two subgroups, mild and moderate ...
|
2 Participants
n=4 Participants • Two subgroups, mild and moderate ...
|
PRIMARY outcome
Timeframe: Baseline, 6 weeks, 12 weeksStrength assessment of the quadriceps muscles using a handheld dynamometer, measured in Newtons. Subjects performed 3 repetitions of maximal effort, separated by two minutes of rest between each. The average of the 3 repetitions was recorded as the subjects' 1 repetition maximum. A positive change indicates increased quadriceps strength.
Outcome measures
| Measure |
Control
n=2 Participants
Device: Cionic Neural Sleeve NS-100. Participants will wear the device during the 12-week exercise and walking program. There will be no stimulation.
12-week exercise and walking program: The exercise program requires isometric quadriceps contractions in a supine position with a rolled-up towel placed behind the knee. The exercise program will be performed by participants 5 days per week for 12 weeks. The walking program will be performed 3 days per week for 12 weeks. Participants will walk for 10 minutes and then gradually increase walking time to 30 minutes by the end of the study. Participants will wear the device during the exercise and walking program, which may range from 1 minute to 35 minutes per day.
|
NMES
n=1 Participants
Device: Cionic Neural Sleeve NS-100. Participants will wear the device during the 12-week exercise and walking program and receive stimulation assistance during the exercise sessions.
12-week exercise and walking program: The exercise program requires isometric quadriceps contractions in a supine position with a rolled-up towel placed behind the knee. The exercise program will be performed by participants 5 days per week for 12 weeks. The walking program will be performed 3 days per week for 12 weeks. Participants will walk for 10 minutes and then gradually increase walking time to 30 minutes by the end of the study. Participants will wear the device during the exercise and walking program, which may range from 1 minute to 35 minutes per day.
NMES: Sleeve applies neuromuscular stimulation during exercises to help contract appropriate muscles at appropriate times.
|
NMES and FES
n=1 Participants
Device: Cionic Neural Sleeve NS-100. Participants will wear the device during the 12-week exercise and walking program and receive stimulation assistance during the exercise and walking sessions.
12-week exercise and walking program: The exercise program requires isometric quadriceps contractions in a supine position with a rolled-up towel placed behind the knee. The exercise program will be performed by participants 5 days per week for 12 weeks. The walking program will be performed 3 days per week for 12 weeks. Participants will walk for 10 minutes and then gradually increase walking time to 30 minutes by the end of the study. Participants will wear the device during the exercise and walking program, which may range from 1 minute to 35 minutes per day.
NMES: Sleeve applies neuromuscular stimulation during exercises to help contract appropriate muscles at appropriate times.
FES: Sleeve applies functional electrical stimulation as patients walk to help contract appropriate muscles at appropriate times.
|
|---|---|---|---|
|
Change in Average Maximal Voluntary Isometric Contraction of the Quadriceps From Baseline
Change in Quadriceps Strength From Baseline to Week 6
|
76.62 Newtons
Interval 69.1 to 84.13
|
70.23 Newtons
Interval 70.23 to 70.23
|
148.47 Newtons
Interval 148.47 to 148.47
|
|
Change in Average Maximal Voluntary Isometric Contraction of the Quadriceps From Baseline
Change in Quadriceps Strength From Baseline to Week 12
|
76.38 Newtons
Interval 22.23 to 130.53
|
79.90 Newtons
Interval 79.9 to 79.9
|
198.90 Newtons
Interval 198.9 to 198.9
|
PRIMARY outcome
Timeframe: Baseline, 6 weeks, 12 weeksWestern Ontario/McMaster Universities Osteoarthritis Index (WOMAC) pain questionnaire to measure perceived pain, measured by score. Scores on the WOMAC pain subscale range from 0 to 20, with high scores indicative of worse pain. A positive change indicates improvement.
Outcome measures
| Measure |
Control
n=2 Participants
Device: Cionic Neural Sleeve NS-100. Participants will wear the device during the 12-week exercise and walking program. There will be no stimulation.
12-week exercise and walking program: The exercise program requires isometric quadriceps contractions in a supine position with a rolled-up towel placed behind the knee. The exercise program will be performed by participants 5 days per week for 12 weeks. The walking program will be performed 3 days per week for 12 weeks. Participants will walk for 10 minutes and then gradually increase walking time to 30 minutes by the end of the study. Participants will wear the device during the exercise and walking program, which may range from 1 minute to 35 minutes per day.
|
NMES
n=1 Participants
Device: Cionic Neural Sleeve NS-100. Participants will wear the device during the 12-week exercise and walking program and receive stimulation assistance during the exercise sessions.
12-week exercise and walking program: The exercise program requires isometric quadriceps contractions in a supine position with a rolled-up towel placed behind the knee. The exercise program will be performed by participants 5 days per week for 12 weeks. The walking program will be performed 3 days per week for 12 weeks. Participants will walk for 10 minutes and then gradually increase walking time to 30 minutes by the end of the study. Participants will wear the device during the exercise and walking program, which may range from 1 minute to 35 minutes per day.
NMES: Sleeve applies neuromuscular stimulation during exercises to help contract appropriate muscles at appropriate times.
|
NMES and FES
n=1 Participants
Device: Cionic Neural Sleeve NS-100. Participants will wear the device during the 12-week exercise and walking program and receive stimulation assistance during the exercise and walking sessions.
12-week exercise and walking program: The exercise program requires isometric quadriceps contractions in a supine position with a rolled-up towel placed behind the knee. The exercise program will be performed by participants 5 days per week for 12 weeks. The walking program will be performed 3 days per week for 12 weeks. Participants will walk for 10 minutes and then gradually increase walking time to 30 minutes by the end of the study. Participants will wear the device during the exercise and walking program, which may range from 1 minute to 35 minutes per day.
NMES: Sleeve applies neuromuscular stimulation during exercises to help contract appropriate muscles at appropriate times.
FES: Sleeve applies functional electrical stimulation as patients walk to help contract appropriate muscles at appropriate times.
|
|---|---|---|---|
|
Change in Perceived Pain Scores From Baseline
Change in Pain From Baseline to Week 6
|
0.5 score on a scale
Interval 0.0 to 1.0
|
-1 score on a scale
Interval -1.0 to -1.0
|
1 score on a scale
Interval 1.0 to 1.0
|
|
Change in Perceived Pain Scores From Baseline
Change in Pain From Baseline to Week 12
|
-2 score on a scale
Interval -5.0 to 1.0
|
0 score on a scale
Interval 0.0 to 0.0
|
5 score on a scale
Interval 5.0 to 5.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 weeks, 12 weeksWOMAC physical function (WOMAC-PF) questionnaire to measure perceived functional capacity, measured by score. Scores on the WOMAC-PF subscale range from 0 to 68, with high scores indicative of worse functional limitations.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 weeks, 12 weeksMeasured by gait speed via the 10-meter walk test (meters per second) and walking endurance via the 6-minute walk test (meters).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: DailyMeasured by the usage log of the device or exercise diary/calendar, measured in minutes.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 weeks, 12 weeksMeasured by thigh circumference using a tape measure and prediction model to estimate muscle volume, measured in cubic centimeters.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 weeks, 12 weeksMeasured by the Five Times Sit to Stand Test, measured in seconds.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 weeks, 12 weeksShort Form 36 questionnaire to measure quality of life, measured by score. Score ranges from 0 to 100, with 0 representing extreme interference, and 100 representing no interference in quality of life.
Outcome measures
Outcome data not reported
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
NMES
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
NMES and FES
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
- Publication restrictions are in place