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Electrical Stimulation

Control for Osteoarthritis

N/A
Waitlist Available
Research Sponsored by Cionic, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 weeks, 12 weeks
Awards & highlights

Study Summary

This trial will look at how electrical stimulation through a home-based medical device can help people with knee osteoarthritis (KOA) by improving muscle mass, strength, walking, pain, & perceived function.

Who is the study for?
Adults aged 22-75 with knee osteoarthritis who can walk for 30 minutes and tolerate an electrical stimulation device for up to an hour. They should not have had a change in medication or symptom exacerbation recently, no injections into the knees in the past year, and no history of severe arthritis, neurological diseases, or use of similar devices.Check my eligibility
What is being tested?
The trial is testing if a home-based program using electrical stimulation over 12 weeks improves muscle strength, pain relief, walking ability, and overall function in adults with knee osteoarthritis compared to those without such stimulation.See study design
What are the potential side effects?
Potential side effects may include discomfort from the device's electrical stimulation leading to skin irritation or muscle fatigue. There might also be temporary increased joint pain after exercise sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 22 and 75 years old with knee osteoarthritis.
Select...
I can walk for 30 minutes at a time, three times a week, with or without help.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 weeks, 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks, 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Maximal Voluntary Isometric Contraction of the Quadriceps Using a Dynamometer
Change in Perceived Pain Scores Assessed by the Western Ontario/McMaster Universities Osteoarthritis Index (WOMAC)
Other outcome measures
Adherence to the Program
Change in Functional Ability of the Lower Limb
Change in Perceived Functional Capacity
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: NMES and FESExperimental Treatment3 Interventions
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.
Group II: NMESExperimental Treatment2 Interventions
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.
Group III: ControlExperimental Treatment1 Intervention
Device: Cionic Neural Sleeve NS-100. Participants will wear the device during the 12-week exercise and walking program. There will be no stimulation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NMES
2018
Completed Phase 4
~890
FES
2013
N/A
~200

Find a Location

Who is running the clinical trial?

Cionic, Inc.Lead Sponsor
3 Previous Clinical Trials
96 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the upper age limit for this study extend beyond 60 years of age?

"This clinical trial has designated a participant age range of 22 to 75. In contrast, there are 37 studies open to minors and 642 trials that accept seniors over the age of 65."

Answered by AI

Is registration now open for the experiment?

"Affirmative. According to clinicaltrials.gov, this medical investigation is currently accepting patients and began recruitment on March 1st 2023. Updating of the trial latest occurred on 3/10/2023 with 45 participants needed from a single location."

Answered by AI

What is the cap on how many participants may join this clinical analysis?

"Affirmative. Evidenced on clinicaltrials.gov, this medical research is presently seeking volunteers to join the experiment which commenced March 1st 2023 and was most recently edited ten days later. 45 participants must be enrolled from one location."

Answered by AI

Is participation in this medical research open to the public?

"Patients with knee osteoarthritis aged 22-75 are eligible to participate in this clinical trial, of which 45 positions need to be filled."

Answered by AI
~2 spots leftby Oct 2024