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

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ClinicalTrials.gov Identifier: NCT03058796
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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
Upper Extremity Hemipelegia Stroke 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 19, 2017
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : February 28, 2021

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 Name: 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 Name: CCFES

Device: Hand Therapy Video Games
The use of video games with NMES to encourage therapeutic hand movement at home
Other Name: HTVG




Primary Outcome Measures :
  1. Box and Block Test change [ Time Frame: 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 [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  • Montreal Cognitive Assessment score >=22 (cutoff set to allow some mild cognitive impairment)
  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03058796


Contacts
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Contact: Jayme S Knutson, PhD (216) 791-3800 ext 2045 Jayme.Knutson@va.gov
Contact: Holly B Henry (216) 791-3800 ext 4657 holly.henry@va.gov

Locations
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United States, Ohio
Louis Stokes VA Medical Center, Cleveland, OH Recruiting
Cleveland, Ohio, United States, 44106
Contact: Holly B Henry    216-791-3800 ext 4657    holly.henry@va.gov   
Principal Investigator: Jayme S. Knutson, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Jayme S. Knutson, PhD Louis Stokes VA Medical Center, Cleveland, OH

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03058796     History of Changes
Other Study ID Numbers: N2249-R
I01RX00249 ( Other Grant/Funding Number: Department of Veterans Affairs Rehab. Res. & Dev. )
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
stroke
rehabilitation
Hemipelegia

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases