A 12-Week Home-Based Electrical Stimulation Program for Strength in Adults With Knee Osteoarthritis
Stopped early · Not applicable
Conditions studied: Osteoarthritis, Osteoarthritis, Knee
In brief
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.
Key facts
- Study ID
- NCT05765435
- Run by
- Cionic, Inc.
- People needed
- 6
- Starts
- 2023-06-27
- Expected to finish
- 2023-11-07
- Last updated by the study team
- 2025-07-03
Who can join
Age: 22 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Cionic, Inc. — San Francisco, California, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.