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

Part of paid clinical trials in San Francisco, California.

Sponsor
Cionic, Inc.
Study ID
NCT05765435
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 12-week exercise and walking program — OTHER
    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.
  • NMES — DEVICE
    Sleeve applies neuromuscular stimulation during exercises to help contract appropriate muscles at appropriate times.
  • FES — DEVICE
    Sleeve applies functional electrical stimulation as patients walk to help contract appropriate muscles at appropriate times.

Study Details

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 Dates

Start date
Jun 27, 2023
Status verified
Jul 2025
Primary completion
Nov 7, 2023
Completion
Nov 7, 2023

Study Design

Enrollment
6 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Control
    Device: Cionic Neural Sleeve NS-100. Participants will wear the device during the 12-week exercise and walking program. There will be no stimulation.
  • Experimental: NMES
    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.
  • Experimental: NMES and FES
    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.

Primary Outcome Measure

Change in Average Maximal Voluntary Isometric Contraction of the Quadriceps From Baseline [ Time Frame: Baseline, 6 weeks, 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cionic, Inc.San FranciscoCalifornia94133-

Find similar trials in San Francisco, CA

By condition
Osteoarthritis (other)
By specialty
OrthopedicsMusculoskeletal disorders
By research site
Cionic, Inc.· San Francisco, CA

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