A 12-Week Home-Based Electrical Stimulation Program for Strength in Adults With Knee Osteoarthritis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	22 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05765435
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Cionic, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Osteoarthritis, Osteoarthritis, Knee

Additional Details

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.

Arms & Interventions

Arms

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.

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.

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.

Interventions

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.

Device: - FES

Sleeve applies functional electrical stimulation as patients walk to help contract appropriate muscles at appropriate times.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Cionic, Inc., San Francisco, California

Status

Recruiting

Address

Cionic, Inc.

San Francisco, California, 94133

Site Contact

Rebecca Webster

[email protected]

925-788-6649

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