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

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Description

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.

Study Overview

Start Date
June 27, 2023
Completion Date
October 1, 2024
Enrollment
45
Date Posted
March 13, 2023
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Cionic, Inc.
San Francisco, California 94133, United States

Eligibility

Minimum Age (years)
22
Maximum Age (years)
75
Eligibility 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 replacement surgery
History of other types of arthritis
History of neurological disease
History of seizures or diagnosed with epilepsy/seizures
Current pregnancy

Study Contact Info

Study Contact Name
Rebecca Webster, PhD
Study Contact Email
Study Contact Phone

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
Yes
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.
NCTid (if applicable)
NCT05765435