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Electrical Stimulation

Contralaterally Controlled Functional Electrical Stimulation (CCFES) for Upper Extremity Hemiplegia

Phase 2
Waitlist Available
Led By Jayme S. Knutson, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 weeks,12 weeks, 36 weeks
Awards & highlights

Study Summary

This trial will test whether adding a video game to electrical stimulation therapy can improve hand function in stroke patients.

Eligible Conditions
  • Upper Extremity Hemiplegia
  • Stroke

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 weeks,12 weeks, 36 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 weeks,12 weeks, 36 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
Box and Block Test Score
Secondary outcome measures
Action Research Arm Test (ARAT) Score

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CCFES Video Game TherapyExperimental Treatment2 Interventions
CCFES Video Game Therapy integrates custom designed hand therapy video games with CCFES which enables participants to use the video game component at home instead of repetitive hand opening exercises.
Group II: CCFES TherapyActive Control1 Intervention
CCFES uses surface electrodes over the paretic finger and thumb extensors to deliver stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. Thus, volitional opening of the nonparetic hand produces stimulated opening of the paretic hand. CCFES enables stroke survivors to open and close their paretic hand and practice using it in therapy sessions. The treatment regimen includes CCFES-mediated: 1) home-based self-administered hand opening exercises, and 2) lab-based therapist-guided functional task practice.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Contralaterally Controlled Functional Electrical Stimulation (CCFES)
2017
Completed Phase 2
~60
Hand Therapy Video Games
2017
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,551 Total Patients Enrolled
Jayme S. Knutson, PhDPrincipal InvestigatorLouis Stokes VA Medical Center, Cleveland, OH
3 Previous Clinical Trials
173 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Contralaterally Controlled Functional Electrical Stimulation Plus Video Games for Hand Therapy After Stroke
2017. "Contralaterally Controlled Functional Electrical Stimulation Plus Video Games for Hand Therapy After Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03058796.
~7 spots leftby Apr 2025
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