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

Phase 2

Completed

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 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.

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
Box and Block Test Score	0 weeks,12 weeks, 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

Name	Time	Method
Action Research Arm Test (ARAT) Score	0 weeks, 12 weeks, 36 weeks	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)

Locations (1): Louis Stokes VA Medical Center, Cleveland, OH
🇺🇸
Cleveland, Ohio, United States
Louis Stokes VA Medical Center, Cleveland, OH
🇺🇸Cleveland, Ohio, United States