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

Cionic, Inc.6 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Interventions

12-week exercise and walking programOTHER

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.

NMESDEVICE

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

FESDEVICE

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

Eligibility

Sex: ALLMin age: 22 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.