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

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

Detailed Description
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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.

Official Title
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Contralaterally Controlled FES Plus Video Games for Hand Therapy After Stroke

Conditions
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Upper Extremity Hemipelegia, Stroke

Intervention / Treatment
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* Device: Contralaterally Controlled Functional Electrical Stimulation (CCFES)
* Device: Hand Therapy Video Games


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CCFES Therapy<br>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)<br>* 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.<br>* Other names: CCFES;|
| Experimental: CCFES Video Game Therapy<br>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)<br>* 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.<br>* Other names: CCFES;Device: Hand Therapy Video Games<br>* The use of video games with NMES to encourage therapeutic hand movement at home<br>* Other names: HTVG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline 3,6,9,12,24 and 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arm Motor Abilities Test (AMAT) change | The AMAT assesses the patient's ability to execute specific upper limb activities of daily living (ADL) tasks | Baseline 3,6,9,12,24 and 36 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, rehabilitation, Hemipelegia