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

NCT05765435 | Terminated Results FDA Device

• 1 other identifier: CIONIC-05-001
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis; Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline, 6 weeks, 12 weeks

• 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.

  Baseline, 6 weeks, 12 weeks

Other Outcomes (6)

• Change in Perceived Functional Capacity

  Baseline, 6 weeks, 12 weeks

• Change in Walking Performance

  Baseline, 6 weeks, 12 weeks

• Adherence to the Program

  Daily

Study Arms (3)

Control

OTHER

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

NMES

EXPERIMENTAL

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; Device: NMES

NMES and FES

EXPERIMENTAL

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; Device: NMES; Device: FES

Interventions

12-week exercise and walking program OTHER

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.

Control; NMES; NMES and FES

NMES DEVICE

Sleeve applies neuromuscular stimulation during exercises to help contract appropriate muscles at appropriate times.

Also known as: External functional neuromuscular stimulator

NMES; NMES and FES

FES DEVICE

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

Also known as: External functional neuromuscular stimulator

NMES and FES

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 replacement surgery
• History of other types of arthritis
• History of neurological disease
• History of seizures or diagnosed with epilepsy/seizures
• Current pregnancy

Sponsors & Collaborators

• Cionic, Inc.: lead

Study Sites (1)

Cionic, Inc.

San Francisco, California, 94133, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee

Interventions

Exercise

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Rebecca Webster
• Organization: Cionic

rebecca@cionic.com

888-481-3724

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Operations and Research

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 13, 2023
• Study Start: June 27, 2023
• Primary Completion: November 7, 2023
• Study Completion: November 7, 2023
• Last Updated: July 3, 2025
• Results First Posted: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)