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

Primary Purpose

Upper Extremity Hemipelegia, Stroke

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Contralaterally Controlled Functional Electrical Stimulation (CCFES)
Hand Therapy Video Games
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Upper Extremity Hemipelegia focused on measuring stroke, rehabilitation, Hemipelegia

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Louis Stokes VA Medical Center, Cleveland, OH

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CCFES Therapy

CCFES Video Game Therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Box and Block Test change
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

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

Full Information

First Posted
February 16, 2017
Last Updated
October 5, 2022
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT03058796
Brief Title
Contralaterally Controlled Functional Electrical Stimulation Plus Video Games for Hand Therapy After Stroke
Official Title
Contralaterally Controlled FES Plus Video Games for Hand Therapy After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 19, 2017 (Actual)
Primary Completion Date
June 13, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Extremity Hemipelegia, Stroke
Keywords
stroke, rehabilitation, Hemipelegia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CCFES Therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
CCFES Video Game Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Contralaterally Controlled Functional Electrical Stimulation (CCFES)
Other Intervention Name(s)
CCFES
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Hand Therapy Video Games
Other Intervention Name(s)
HTVG
Intervention Description
The use of video games with NMES to encourage therapeutic hand movement at home
Primary Outcome Measure Information:
Title
Box and Block Test change
Description
The Box and Blocks Test counts how many blocks a patient can pick up, move over a barrier, and release in 60 seconds.
Time Frame
Baseline 3,6,9,12,24 and 36 weeks
Secondary Outcome Measure Information:
Title
Arm Motor Abilities Test (AMAT) change
Description
The AMAT assesses the patient's ability to execute specific upper limb activities of daily living (ADL) tasks
Time Frame
Baseline 3,6,9,12,24 and 36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jayme S. Knutson, PhD
Organizational Affiliation
Louis Stokes VA Medical Center, Cleveland, OH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Louis Stokes VA Medical Center, Cleveland, OH
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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