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

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.

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)

- Montreal Cognitive Assessment score >=22 (cutoff set to allow some mild cognitive
impairment)

- 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

- 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