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

Osteoarthritis Clinical Trial

Official title:

Effects of an Electrical Stimulation Program on Strength, Functional Capacity, Pain, and Gait in Individuals With Knee Osteoarthritis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05765435
• Other study ID #: CIONIC-05-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 27, 2023
• Est. completion date: October 2024

Study information

• Verified date: March 2024
• Source: Cionic, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.
• FES
Sleeve applies functional electrical stimulation as patients walk to help contract appropriate muscles at appropriate times.

Locations

Country	Name	City	State
United States	Cionic, Inc.	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Cionic, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Perceived Functional Capacity	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.	Baseline, 6 weeks, 12 weeks
Other	Change in Walking Performance	Measured by gait speed via the 10-meter walk test (meters per second) and walking endurance via the 6-minute walk test (meters).	Baseline, 6 weeks, 12 weeks
Other	Adherence to the Program	Measured by the usage log of the device or exercise diary/calendar, measured in minutes.	Daily
Other	Change in Thigh Muscle Volume	Measured by thigh circumference using a tape measure and prediction model to estimate muscle volume, measured in cubic centimeters.	Baseline, 6 weeks, 12 weeks
Other	Change in Functional Ability of the Lower Limb	Measured by the Five Times Sit to Stand Test, measured in seconds.	Baseline, 6 weeks, 12 weeks
Other	Change in Perceived Quality of Life	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.	Baseline, 6 weeks, 12 weeks
Primary	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.	Baseline, 6 weeks, 12 weeks
Primary	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.	Baseline, 6 weeks, 12 weeks