Osteoarthritis, Osteoarthritis, Knee
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHER12-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.
DEVICENMES
Sleeve applies neuromuscular stimulation during exercises to help contract appropriate muscles at appropriate times.
DEVICEFES
Sleeve applies functional electrical stimulation as patients walk to help contract appropriate muscles at appropriate times.
Sponsors
Cionic, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Persons with knee osteoarthritis between the ages of 22 and 75 2. Ability to walk a duration of 30 minutes per walking session (with or without an assistive device), for three days per week 3. Able to tolerate the device for up to 1 hour per lab session 4. No recent change in medication or exacerbation of symptoms over the last 60 days 5. Radiographic KOA Kellgren and Lawrence grade 2 or 3 or physician diagnosed mild or moderate KOA if radiographic imaging is not available 6. No hyaluronic acid or cortisone injection into knees in previous 12 months
Exclusion criteria
1. Lower motor neuron disease or injury (e.g. peripheral neuropathy) that may impair response to stimulation 2. Absent sensation in the impacted or more impacted leg 3. Inadequate response to stimulation, as defined as inability to achieve muscle contraction or tolerate stimulation 4. Inability to ambulate with the sleeve in place of an ankle foot orthosis (AFO)/knee ankle foot orthosis (KAFO) if utilized 5. Use of FES devices in the past year 6. Demand-type cardiac pacemaker or defibrillator 7. Malignant tumor in the impacted or more impacted leg 8. Existing thrombosis in the impacted or more impacted leg 9. Fracture or dislocation in the impacted or more impacted leg that could be adversely affected by motion from stimulation 10. History of knee replacement surgery 11. History of other types of arthritis 12. History of neurological disease 13. History of seizures or diagnosed with epilepsy/seizures 14. Current pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Average Maximal Voluntary Isometric Contraction of the Quadriceps From Baseline | Baseline, 6 weeks, 12 weeks | 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. |
| Change in Perceived Pain Scores From Baseline | Baseline, 6 weeks, 12 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adherence to the Program | Daily | Measured by the usage log of the device or exercise diary/calendar, measured in minutes. |
| Change in Thigh Muscle Volume | Baseline, 6 weeks, 12 weeks | Measured by thigh circumference using a tape measure and prediction model to estimate muscle volume, measured in cubic centimeters. |
| Change in Perceived Functional Capacity | Baseline, 6 weeks, 12 weeks | 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. |
| Change in Perceived Quality of Life | Baseline, 6 weeks, 12 weeks | 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. |
| Change in Functional Ability of the Lower Limb | Baseline, 6 weeks, 12 weeks | Measured by the Five Times Sit to Stand Test, measured in seconds. |
| Change in Walking Performance | Baseline, 6 weeks, 12 weeks | Measured by gait speed via the 10-meter walk test (meters per second) and walking endurance via the 6-minute walk test (meters). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 2 |
| 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. | 1 |
| 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. | 1 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Control | NMES | NMES and FES | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Severity of Knee Osteoarthritis Mild Severity of the Instrumented Leg | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Severity of Knee Osteoarthritis Moderate Severity of the Instrumented Leg | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 1 | 0 / 1 |
| other Total, other adverse events | 0 / 2 | 0 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 2 | 0 / 1 | 0 / 1 |
Outcome results
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.
Time frame: Baseline, 6 weeks, 12 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Control | Change in Average Maximal Voluntary Isometric Contraction of the Quadriceps From Baseline | Change in Quadriceps Strength From Baseline to Week 6 | 76.62 Newtons |
| Control | Change in Average Maximal Voluntary Isometric Contraction of the Quadriceps From Baseline | Change in Quadriceps Strength From Baseline to Week 12 | 76.38 Newtons |
| NMES | Change in Average Maximal Voluntary Isometric Contraction of the Quadriceps From Baseline | Change in Quadriceps Strength From Baseline to Week 6 | 70.23 Newtons |
| NMES | Change in Average Maximal Voluntary Isometric Contraction of the Quadriceps From Baseline | Change in Quadriceps Strength From Baseline to Week 12 | 79.90 Newtons |
| NMES and FES | Change in Average Maximal Voluntary Isometric Contraction of the Quadriceps From Baseline | Change in Quadriceps Strength From Baseline to Week 6 | 148.47 Newtons |
| NMES and FES | Change in Average Maximal Voluntary Isometric Contraction of the Quadriceps From Baseline | Change in Quadriceps Strength From Baseline to Week 12 | 198.90 Newtons |
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.
Time frame: Baseline, 6 weeks, 12 weeks
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Control | Change in Perceived Pain Scores From Baseline | Change in Pain From Baseline to Week 6 | 0.5 score on a scale |
| Control | Change in Perceived Pain Scores From Baseline | Change in Pain From Baseline to Week 12 | -2 score on a scale |
| NMES | Change in Perceived Pain Scores From Baseline | Change in Pain From Baseline to Week 6 | -1 score on a scale |
| NMES | Change in Perceived Pain Scores From Baseline | Change in Pain From Baseline to Week 12 | 0 score on a scale |
| NMES and FES | Change in Perceived Pain Scores From Baseline | Change in Pain From Baseline to Week 6 | 1 score on a scale |
| NMES and FES | Change in Perceived Pain Scores From Baseline | Change in Pain From Baseline to Week 12 | 5 score on a scale |
Other Pre-specified
Adherence to the Program
Measured by the usage log of the device or exercise diary/calendar, measured in minutes.
Time frame: Daily
Other Pre-specified
Change in Functional Ability of the Lower Limb
Measured by the Five Times Sit to Stand Test, measured in seconds.
Time frame: Baseline, 6 weeks, 12 weeks
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.
Time frame: Baseline, 6 weeks, 12 weeks
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.
Time frame: Baseline, 6 weeks, 12 weeks
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.
Time frame: Baseline, 6 weeks, 12 weeks
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).
Time frame: Baseline, 6 weeks, 12 weeks