Clinical trial NCT05765435: A 12-Week Home-Based Electrical Stimulation Program for Strength in Adults with Knee Osteoarthritis
Official title: Effects of an Electrical Stimulation Program on Strength, Functional Capacity, Pain, and Gait in Individuals with Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteoarthritis
Osteoarthritis, Knee
Lead sponsor: Cionic, Inc.
Sponsor class: INDUSTRY
First posted: 2023-03-13
Enrollment: 6
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Maximal Voluntary Isometric Contraction of the Quadriceps Using a Dynamometer
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in Perceived Pain Scores Assessed by the Western Ontario/McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Baseline, 6 weeks, 12 weeks
Secondary outcomes:
Other outcomes:
measure: Change in Perceived Functional Capacity
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in Walking Performance
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Adherence to the Program
timeFrame: Daily
measure: Change in Thigh Muscle Volume
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in Functional Ability of the Lower Limb
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Change in Perceived Quality of Life
timeFrame: Baseline, 6 weeks, 12 weeks
Locations:
city: San Francisco
country: United States
facility: Cionic, Inc.
state: California
Study officials:
References: