A 12-Week Home-Based Electrical Stimulation Program for Strength in Adults With Knee Osteoarthritis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 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. |
Other: 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.
|
| Experimental: 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. |
Other: 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.
Device: NMES
Sleeve applies neuromuscular stimulation during exercises to help contract appropriate muscles at appropriate times.
Other Names:
|
| Experimental: 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. |
Other: 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.
Device: NMES
Sleeve applies neuromuscular stimulation during exercises to help contract appropriate muscles at appropriate times.
Other Names:
Device: FES
Sleeve applies functional electrical stimulation as patients walk to help contract appropriate muscles at appropriate times.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in Maximal Voluntary Isometric Contraction of the Quadriceps Using a Dynamometer [Baseline, 6 weeks, 12 weeks]
Strength assessment of the quadriceps muscles using a handheld dynamometer, measured in Newtons.
- Change in Perceived Pain Scores Assessed by the Western Ontario/McMaster Universities Osteoarthritis Index (WOMAC) [Baseline, 6 weeks, 12 weeks]
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.
Other Outcome Measures
- 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 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).
- 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 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 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Persons with knee osteoarthritis between the ages of 22 and 75
-
Ability to walk a duration of 30 minutes per walking session (with or without an assistive device), for three days per week
-
Able to tolerate the device for up to 1 hour per lab session
-
No recent change in medication or exacerbation of symptoms over the last 60 days
-
Radiographic KOA Kellgren and Lawrence grade 2 or 3 or physician diagnosed mild or moderate KOA if radiographic imaging is not available
-
No hyaluronic acid or cortisone injection into knees in previous 12 months
Exclusion Criteria:
-
Lower motor neuron disease or injury (e.g. peripheral neuropathy) that may impair response to stimulation
-
Absent sensation in the impacted or more impacted leg
-
Inadequate response to stimulation, as defined as inability to achieve muscle contraction or tolerate stimulation
-
Inability to ambulate with the sleeve in place of an ankle foot orthosis (AFO)/knee ankle foot orthosis (KAFO) if utilized
-
Use of FES devices in the past year
-
Demand-type cardiac pacemaker or defibrillator
-
Malignant tumor in the impacted or more impacted leg
-
Existing thrombosis in the impacted or more impacted leg
-
Fracture or dislocation in the impacted or more impacted leg that could be adversely affected by motion from stimulation
-
History of knee surgery
-
History of other types of arthritis
-
History of neurological disease
-
History of seizures or diagnosed with epilepsy/seizures
-
Current pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cionic, Inc. | San Francisco | California | United States | 94133 |
Sponsors and Collaborators
- Cionic, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIONIC-05-001