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

Not Applicable

Active, not recruiting

• Conditions: Osteoarthritis; Osteoarthritis, Knee
• Interventions: Other: 12-week exercise and walking program; Device: NMES; Device: FES

• Registration Number: NCT05765435
• Lead Sponsor: Cionic, Inc.

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.

Study Timeline

• Study First Submitted: 2023-03-01
• Study First Submitted QC: 2023-03-10
• Study First Posted: 2023-03-13
• Study Start: 2023-06-27
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13
• Primary Completion: 2026-01-12
• Study Completion: 2026-01-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NMES and FES	12-week exercise and walking program	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.
Control	12-week exercise and walking program	Device: Cionic Neural Sleeve NS-100. Participants will wear the device during the 12-week exercise and walking program. There will be no stimulation.
NMES and FES	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.
NMES	12-week exercise and walking program	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.
NMES	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.
NMES and FES	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 and walking sessions.

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Cionic, Inc.; 🇺🇸 San Francisco, California, United States