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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of an Electrical Stimulation Program on Strength, Functional Capacity, Pain, and Gait in Individuals With Knee Osteoarthritis

Conditions
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Osteoarthritis, Osteoarthritis, Knee

Intervention / Treatment
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* Other: 12-week exercise and walking program
* Device: NMES
* Device: FES


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br>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<br>* 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.<br>|
| Experimental: NMES<br>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<br>* 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.<br>Device: NMES<br>* Sleeve applies neuromuscular stimulation during exercises to help contract appropriate muscles at appropriate times.<br>* Other names: External functional neuromuscular stimulator;|
| Experimental: NMES and FES<br>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<br>* 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.<br>Device: NMES<br>* Sleeve applies neuromuscular stimulation during exercises to help contract appropriate muscles at appropriate times.<br>* Other names: External functional neuromuscular stimulator;Device: FES<br>* Sleeve applies functional electrical stimulation as patients walk to help contract appropriate muscles at appropriate times.<br>* Other names: External functional neuromuscular stimulator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Maximal Voluntary Isometric Contraction of the Quadriceps Using a Dynamometer | Strength assessment of the quadriceps muscles using a handheld dynamometer, measured in Newtons. | Baseline, 6 weeks, 12 weeks | 
| Change in Perceived Pain Scores Assessed by the Western Ontario/McMaster Universities Osteoarthritis Index (WOMAC) | 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. | Baseline, 6 weeks, 12 weeks |