Contralaterally Controlled Functional Electrical Stimulation Plus Video Games for Hand Therapy After Stroke
Condition: Upper Extremity Hemiplegia; Stroke
MeSH terms: Stroke; Hemiplegia
Intervention: Contralaterally Controlled Functional Electrical Stimulation (CCFES); Hand Therapy Video Games
Intervention description: 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.; The use of video games with CCFES to encourage therapeutic hand movement at home
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 52.0
Sex: All
Minimum age: 21 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: stroke; rehabilitation; Hemiplegia

Summary:

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

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