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

Contralaterally Controlled FES Plus Video Games for Hand Therapy After Stroke

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

Study Overview

• Status: Completed
• Conditions: Stroke; Upper Extremity Hemiplegia
• Intervention / Treatment: Device: Contralaterally Controlled Functional Electrical Stimulation (CCFES); Device: Hand Therapy Video Games

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 and activity limitation will be assessed at 0 (baseline), 12 (end of treatment), and 36 (6 months follow-up) wks. The planned treatment dose will be the same for both groups: 10 sessions per week of self-administered treatment at home plus 20 sessions of group-specific occupational therapy in the lab over 12 weeks.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Louis Stokes VA Medical Center, Cleveland, OH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 stimulation during pregnancy
• participating in occupational therapy or other rehabilitation therapies to the upper extremity
• severe shoulder or hand pain

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 CCFES to encourage therapeutic hand movement at home; Other Names: HTVG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Box and Block Test Score	The Box and Blocks Test counts how many blocks a patient can pick up, move over a barrier, and release in 60 seconds.	0 weeks,12 weeks, 36 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Action Research Arm Test (ARAT) Score	The ARAT is an activity limitation measure that assesses a subject's ability to handle objects differing in size, weight and shape. Min value = 0 (least functional), Max value = 57 (most functional)	0 weeks, 12 weeks, 36 weeks

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Jayme S. Knutson, PhD, Louis Stokes VA Medical Center, Cleveland, OH

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2017
• Primary Completion (Actual): June 13, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: February 16, 2017
• First Submitted That Met QC Criteria: February 16, 2017
• First Posted (Actual): February 23, 2017

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: stroke; rehabilitation; Hemiplegia
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Paralysis; Stroke; Hemiplegia
• Other Study ID Numbers: N2249-R; I01RX00249 (Other Grant/Funding Number: Department of Veterans Affairs Rehab. Res. & Dev.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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