Contralaterally Controlled Functional Electrical Stimulation Plus Video Games for Hand Therapy After Stroke

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Active, not recruiting
CT.gov ID
NCT03058796
Collaborator
(none)
52
1
2
63.4
0.8

Study Details

Study Description

Brief Summary

Determine if adding a video game component to an electrical stimulation therapy improves hand function in stroke patients

Condition or Disease Intervention/Treatment Phase
  • Device: Contralaterally Controlled Functional Electrical Stimulation (CCFES)
  • Device: Hand Therapy Video Games
Phase 2

Detailed Description

A single-blinded randomized controlled trial will be carried out to assess the effects of 12 weeks of Contralaterally Controlled Functional Electrical Stimulation (CCFES) +Hand Therapy Video Games (HTVG) compared to CCFES. Dexterity, upper limb impairment, and activity limitation will be assessed at 0 (baseline), 3, 6, 9, 12 (end of treatment), 24, and 36 wks. Cortical activation (measured with fMRI) will be assessed at 0 and 12 wks. The treatment dose will be the same for both groups: 10 sessions per week (7.5 hrs) of self-administered treatment at home plus 2 sessions per week (3 hrs) of group-specific occupational therapy in the lab.

Study Design

Study Type:
Interventional
Actual Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Contralaterally Controlled FES Plus Video Games for Hand Therapy After Stroke
Actual Study Start Date :
Jun 19, 2017
Anticipated Primary Completion Date :
Jun 13, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: CCFES Therapy

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.

Device: Contralaterally Controlled Functional Electrical Stimulation (CCFES)
The use of surface electrodes over the paretic finger and thumb extensors to deliver electrical stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. 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.
Other Names:
  • CCFES
  • Experimental: CCFES Video Game Therapy

    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.

    Device: Contralaterally Controlled Functional Electrical Stimulation (CCFES)
    The use of surface electrodes over the paretic finger and thumb extensors to deliver electrical stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. 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.
    Other Names:
  • CCFES
  • Device: Hand Therapy Video Games
    The use of video games with NMES to encourage therapeutic hand movement at home
    Other Names:
  • HTVG
  • Outcome Measures

    Primary Outcome Measures

    1. Box and Block Test change [Baseline 3,6,9,12,24 and 36 weeks]

      The Box and Blocks Test counts how many blocks a patient can pick up, move over a barrier, and release in 60 seconds.

    Secondary Outcome Measures

    1. Arm Motor Abilities Test (AMAT) change [Baseline 3,6,9,12,24 and 36 weeks]

      The AMAT assesses the patient's ability to execute specific upper limb activities of daily living (ADL) tasks

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    -> 6 months since a first clinical cortical or subcortical, hemorrhagic or nonhemorrhagic stroke

    • age 21-80 years old

    • unilateral upper limb hemiparesis with finger extensor strength of grade <=4/5 on the Medical Research Council (MRC) scale AND a score of >=1 and <=11/14 on the hand section of the upper extremity Fugl-Meyer Assessment

    • adequate active movement of the shoulder and elbow to position the hand in the workspace for table-top task practice (necessary for the lab task practice sessions)

    • able to follow 3-stage commands

    • able to recall 2 of 3 words after 30 minutes

    • surface stimulation of the paretic finger and thumb extensors produces functional hand opening without pain (this will exclude those who have degree of flexor hypertonia that prevents stimulated hand opening)

    • Functional passive range of motion (minimal resistance) at elbow, wrist, fingers, and thumb, i.e., there exists enough passive range of motion to reach and acquire table-top objects

    • intact vision and hearing

    • medically stable

    • full voluntary opening/closing of the contralateral (less affected) hand

    • demonstrate ability to follow instructions for operating the stimulator or have a caregiver who will assist them

    Exclusion Criteria:
    • co-existing neurologic diagnosis of peripheral nerve injury, Parkinson's disease, spinal cord injury, traumatic brain injury, or multiple sclerosis

    • uncontrolled seizure disorder

    • severely impaired cognition and communication

    • uncompensated hemineglect

    • arm or forearm skin breakdown or edema (to avoid edema-related shunting of current)

    • insensate forearm (to avoid risk of electrical burns)

    • history of potentially fatal cardiac arrhythmias with hemodynamic instability

    • implanted electronic systems (e.g. pacemaker)

    • botulinum toxin injections to any upper extremity muscle within 3 months of enrolling

    • pregnant women due to unknown risks of surface NMES during pregnancy

    • participating in occupational therapy or other rehabilitation therapies to the upper extremity

    • severe shoulder or hand pain

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Louis Stokes VA Medical Center, Cleveland, OH Cleveland Ohio United States 44106

    Sponsors and Collaborators

    • VA Office of Research and Development

    Investigators

    • Principal Investigator: Jayme S. Knutson, PhD, Louis Stokes VA Medical Center, Cleveland, OH

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    VA Office of Research and Development
    ClinicalTrials.gov Identifier:
    NCT03058796
    Other Study ID Numbers:
    • N2249-R
    • I01RX00249
    First Posted:
    Feb 23, 2017
    Last Update Posted:
    Mar 17, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by VA Office of Research and Development
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 17, 2022