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Insufficient rate of accrual.
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The purpose of this research is to investigate if a 12-week program of stimulation assisted activities can combat disuse atrophy for individuals diagnosed with knee osteoarthritis (KOA). This study will use a home-based medical device to administer electrical stimulation and measure its effect on outcomes that include quadriceps strength, perceived functional capacity, pain, and walking performance. It was hypothesized that stimulation assisted activities will show larger muscle mass and strength improvements; improved gait kinematics, pain and perceived function; and a high compliance to the assigned program compared to no stimulation.
The study aims to evaluate the Cionic Neural Sleeve for subjects diagnosed with KOA. All participants will be assigned a Cionic Neural Sleeve to wear on the most impacted leg and be prescribed a home-based exercise and walking program. Participants will be randomly assigned into three groups: (a) control; (b) neuromuscular electrical stimulation (NMES); (c) NMES and functional electrical stimulation (FES). The control group will not receive stimulation for the exercise and walking program, whereas participants in the NMES group will receive stimulation during exercises, and participants in the NMES and FES group will receive stimulation during exercises and walking. The primary outcome measures include quadriceps strength and perceived pain. Exploratory outcome measures include adherence to the program, thigh muscle volume, functional ability of the lower limb, walking performance, perceived functional capacity, and perceived quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Other | Device: Cionic Neural Sleeve NS-100. Participants will wear the device during the 12-week exercise and walking program. There will be no stimulation. |
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| NMES | Experimental | 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. |
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| NMES and FES | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 12-week exercise and walking program | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Average Maximal Voluntary Isometric Contraction of the Quadriceps From Baseline | 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. | Baseline, 6 weeks, 12 weeks |
| Change in Perceived Pain Scores From Baseline | Western 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. | Baseline, 6 weeks, 12 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Perceived Functional Capacity | WOMAC 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. | Baseline, 6 weeks, 12 weeks |
| Change in Walking Performance |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cionic, Inc. | San Francisco | California | 94133 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Average Maximal Voluntary Isometric Contraction of the Quadriceps From Baseline | 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. | Posted | Mean | Full Range | Newtons | Baseline, 6 weeks, 12 weeks |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Webster | Cionic | 888-481-3724 | rebecca@cionic.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 21, 2023 | Jul 1, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| NMES | Device | Sleeve applies neuromuscular stimulation during exercises to help contract appropriate muscles at appropriate times. |
|
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| FES | Device | Sleeve applies functional electrical stimulation as patients walk to help contract appropriate muscles at appropriate times. |
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Measured by gait speed via the 10-meter walk test (meters per second) and walking endurance via the 6-minute walk test (meters). |
| Baseline, 6 weeks, 12 weeks |
| Adherence to the Program | Measured by the usage log of the device or exercise diary/calendar, measured in minutes. | Daily |
| Change in Thigh Muscle Volume | Measured by thigh circumference using a tape measure and prediction model to estimate muscle volume, measured in cubic centimeters. | Baseline, 6 weeks, 12 weeks |
| Change in Functional Ability of the Lower Limb | Measured by the Five Times Sit to Stand Test, measured in seconds. | Baseline, 6 weeks, 12 weeks |
| Change in Perceived Quality of Life | Short 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. | Baseline, 6 weeks, 12 weeks |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Severity of Knee Osteoarthritis | Two subgroups, mild and moderate ... | Count of Participants | Participants |
|
| OG001 | 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. 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. |
| OG002 | 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. 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. |
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| Primary | Change in Perceived Pain Scores From Baseline | Western 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. | Posted | Mean | Full Range | score on a scale | Baseline, 6 weeks, 12 weeks |
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| Other Pre-specified | Change in Perceived Functional Capacity | WOMAC 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. | Not Posted | Baseline, 6 weeks, 12 weeks | Participants |
| Other Pre-specified | Change in Walking Performance | Measured by gait speed via the 10-meter walk test (meters per second) and walking endurance via the 6-minute walk test (meters). | Not Posted | Baseline, 6 weeks, 12 weeks | Participants |
| Other Pre-specified | Adherence to the Program | Measured by the usage log of the device or exercise diary/calendar, measured in minutes. | Not Posted | Daily | Participants |
| Other Pre-specified | Change in Thigh Muscle Volume | Measured by thigh circumference using a tape measure and prediction model to estimate muscle volume, measured in cubic centimeters. | Not Posted | Baseline, 6 weeks, 12 weeks | Participants |
| Other Pre-specified | Change in Functional Ability of the Lower Limb | Measured by the Five Times Sit to Stand Test, measured in seconds. | Not Posted | Baseline, 6 weeks, 12 weeks | Participants |
| Other Pre-specified | Change in Perceived Quality of Life | Short 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. | Not Posted | Baseline, 6 weeks, 12 weeks | Participants |
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | 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. 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. | 0 | 1 | 0 | 1 | 0 | 1 |
| EG002 | 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. 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. | 0 | 1 | 0 | 1 | 0 | 1 |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Moderate Severity of the Instrumented Leg |
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