Contralaterally Controlled Functional Electrical Stimulation Plus Video Games for Hand Therapy After Stroke
Upper Extremity Hemipelegia, Stroke
About this trial
This is an interventional treatment trial for Upper Extremity Hemipelegia focused on measuring stroke, rehabilitation, Hemipelegia
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
Sites / Locations
- Louis Stokes VA Medical Center, Cleveland, OH
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
CCFES Therapy
CCFES Video Game 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.
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.