We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05765435
Recruitment Status : Recruiting
First Posted : March 13, 2023
Last Update Posted : March 13, 2023
Sponsor:
Information provided by (Responsible Party):
Rebecca Webster, Cionic, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Osteoarthritis, Knee Other: 12-week exercise and walking program Device: NMES Device: FES Not Applicable

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of an Electrical Stimulation Program on Strength, Functional Capacity, Pain, and Gait in Individuals With Knee Osteoarthritis
Estimated Study Start Date : March 2023
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.
 Other: 12-week exercise and walking program
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.
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.
 Other: 12-week exercise and walking program
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.

Device: NMES
Sleeve applies neuromuscular stimulation during exercises to help contract appropriate muscles at appropriate times.
Other Name: External functional neuromuscular stimulator
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.
 Other: 12-week exercise and walking program
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.

Device: NMES
Sleeve applies neuromuscular stimulation during exercises to help contract appropriate muscles at appropriate times.
Other Name: External functional neuromuscular stimulator

Device: FES
Sleeve applies functional electrical stimulation as patients walk to help contract appropriate muscles at appropriate times.
Other Name: External functional neuromuscular stimulator


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in Maximal Voluntary Isometric Contraction of the Quadriceps Using a Dynamometer [ Time Frame: Baseline, 6 weeks, 12 weeks ]
    Strength assessment of the quadriceps muscles using a handheld dynamometer, measured in Newtons.

  2. Change in Perceived Pain Scores Assessed by the Western Ontario/McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: Baseline, 6 weeks, 12 weeks ]
    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.


Other Outcome Measures:
  1. Change in Perceived Functional Capacity [ Time Frame: Baseline, 6 weeks, 12 weeks ]
    WOMAC physical function (WOMAC-PF) questionnaire to measure perceived functional capacity, measured by score. Scores on the WOMAC-PF subscale range from 0 to 68, with high scores indicative of worse functional limitations.

  2. Change in Walking Performance [ Time Frame: Baseline, 6 weeks, 12 weeks ]
    Measured by gait speed via the 10-meter walk test (meters per second) and walking endurance via the 6-minute walk test (meters).

  3. Adherence to the Program [ Time Frame: Daily ]
    Measured by the usage log of the device or exercise diary/calendar, measured in minutes.

  4. Change in Thigh Muscle Volume [ Time Frame: Baseline, 6 weeks, 12 weeks ]
    Measured by thigh circumference using a tape measure and prediction model to estimate muscle volume, measured in cubic centimeters.

  5. Change in Functional Ability of the Lower Limb [ Time Frame: Baseline, 6 weeks, 12 weeks ]
    Measured by the Five Times Sit to Stand Test, measured in seconds.

  6. Change in Perceived Quality of Life [ Time Frame: Baseline, 6 weeks, 12 weeks ]
    Short Form 36 questionnaire to measure quality of life, measured by score. Score ranges from 0 to 100, with 0 representing extreme interference, and 100 representing no interference in quality of life.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   22 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05765435


Contacts
Layout table for location contacts
Contact: Rebecca Webster, PhD 925-788-6649 rebecca@cionic.com

Locations
Layout table for location information
United States, California
Cionic, Inc. Recruiting
San Francisco, California, United States, 94133
Contact: Rebecca Webster    925-788-6649    rebecca@cionic.com   
Sponsors and Collaborators
Cionic, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Rebecca Webster, Director of Clinical Operations and Research, Cionic, Inc.
ClinicalTrials.gov Identifier: NCT05765435    
Other Study ID Numbers: CIONIC-05-001
First Posted: March 13, 2023    Key Record Dates
Last Update Posted: March 13, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases