Back to resultsA 12-Week Home-Based Electrical Stimulation Program for Strength in Adults With Knee Osteoarthritis
Primary Purpose
Osteoarthritis, Osteoarthritis, Knee
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
12-week exercise and walking program
NMES
FES
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
Eligibility Criteria
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
Sites / Locations
- Cionic, Inc.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Experimental
Experimental
Arm Label
Control
NMES
NMES and FES
Arm Description
Device: Cionic Neural Sleeve NS-100. Participants will wear the device during the 12-week exercise and walking program. There will be no stimulation.
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05765435
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 27, 2023 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cionic, Inc.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Osteoarthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Other
Arm Description
Device: Cionic Neural Sleeve NS-100. Participants will wear the device during the 12-week exercise and walking program. There will be no stimulation.
Arm Title
NMES
Arm Type
Experimental
Arm Description
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.
Arm Title
NMES and FES
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
12-week exercise and walking program
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
NMES
Other Intervention Name(s)
External functional neuromuscular stimulator
Intervention Description
Sleeve applies neuromuscular stimulation during exercises to help contract appropriate muscles at appropriate times.
Intervention Type
Device
Intervention Name(s)
FES
Other Intervention Name(s)
External functional neuromuscular stimulator
Intervention Description
Sleeve applies functional electrical stimulation as patients walk to help contract appropriate muscles at appropriate times.
Primary Outcome Measure Information:
Title
Change in Maximal Voluntary Isometric Contraction of the Quadriceps Using a Dynamometer
Description
Strength assessment of the quadriceps muscles using a handheld dynamometer, measured in Newtons.
Time Frame
Baseline, 6 weeks, 12 weeks
Title
Change in Perceived Pain Scores Assessed by the Western Ontario/McMaster Universities Osteoarthritis Index (WOMAC)
Description
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.
Time Frame
Baseline, 6 weeks, 12 weeks
Other Pre-specified Outcome Measures:
Title
Change in Perceived Functional Capacity
Description
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.
Time Frame
Baseline, 6 weeks, 12 weeks
Title
Change in Walking Performance
Description
Measured by gait speed via the 10-meter walk test (meters per second) and walking endurance via the 6-minute walk test (meters).
Time Frame
Baseline, 6 weeks, 12 weeks
Title
Adherence to the Program
Description
Measured by the usage log of the device or exercise diary/calendar, measured in minutes.
Time Frame
Daily
Title
Change in Thigh Muscle Volume
Description
Measured by thigh circumference using a tape measure and prediction model to estimate muscle volume, measured in cubic centimeters.
Time Frame
Baseline, 6 weeks, 12 weeks
Title
Change in Functional Ability of the Lower Limb
Description
Measured by the Five Times Sit to Stand Test, measured in seconds.
Time Frame
Baseline, 6 weeks, 12 weeks
Title
Change in Perceived Quality of Life
Description
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.
Time Frame
Baseline, 6 weeks, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca Webster, PhD
Phone
925-788-6649
Email
rebecca@cionic.com
Facility Information:
Facility Name
Cionic, Inc.
City
San Francisco
State/Province
California
ZIP/Postal Code
94133
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Webster
Phone
925-788-6649
Email
rebecca@cionic.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A 12-Week Home-Based Electrical Stimulation Program for Strength in Adults With Knee Osteoarthritis
We'll reach out to this number within 24 hrs