Electrical Stimulation for Osteoarthritis

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Cionic, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

Adults aged 22-75 with knee osteoarthritis who can walk for 30 minutes and tolerate an electrical stimulation device for up to an hour. They should not have had a change in medication or symptom exacerbation recently, no injections into the knees in the past year, and no history of severe arthritis, neurological diseases, or use of similar devices.

Inclusion Criteria

I am between 22 and 75 years old with knee osteoarthritis.

I can use the device for up to an hour during lab sessions.

I haven't had knee injections with hyaluronic acid or cortisone in the last year.

See 3 more

Exclusion Criteria

I cannot walk even with my leg brace on.

I cannot feel my leg that is most affected.

I have a condition like peripheral neuropathy that affects my muscle response.

See 11 more

Treatment Details

Interventions

12-week exercise and walking program (Behavioural Intervention)
FES (Electrical Stimulation)
NMES (Electrical Stimulation)

Trial OverviewThe trial is testing if a home-based program using electrical stimulation over 12 weeks improves muscle strength, pain relief, walking ability, and overall function in adults with knee osteoarthritis compared to those without such stimulation.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: NMES and FESExperimental Treatment3 Interventions

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.

Group II: NMESExperimental Treatment2 Interventions

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.

Group III: ControlExperimental Treatment1 Intervention

Device: Cionic Neural Sleeve NS-100. Participants will wear the device during the 12-week exercise and walking program. There will be no stimulation.