Contralaterally Controlled FES for Hand Opening in Hemiplegic Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      This is a pilot randomized controlled trial of an intervention to improve arm function in
      children ages 6 to 17 with cerebral palsy and upper limb hemiparesis. Twenty participants
      will be randomized to either a group treated with neuromuscular electrical stimulation and
      video games or video games alone. Both groups will receive 6 wks of treatment consisting of
      home and lab sessions. Both the experiment group and control group interventions consist of
      therapist-guided sessions in the rehabilitation clinic and self-administered or
      caregiver-assisted sessions at home. While both groups will receive the same task practice
      and video game training, only the experiment group will receive an electrical stimulation
      device to assist with hand opening during practice. Changes in upper extremity motor
      impairment and function will be assessed for each participant at baseline, mid treatment, end
      of treatment and at 3 mo follow-up.
    

Detailed description: 
      Rehabilitation clinic sessions - These will occur up to twice per week for the first 3 weeks
      and once per week for the second 3 weeks of the 6 week treatment. They are therapist-guided
      and last up to 90 min consisting of 45 minutes of contralaterally-controlled functional
      electrical stimulation (CCFES)-mediated video games and up to 45 minutes of CCFES-mediated
      functional task practice. Early sessions will focus on training the patient and caregiver to
      self-administer play of a CCFES-mediated video game at home. As proficiency with one game
      develops, more games will be introduced. The functional task practice part of the session
      will engage the participant in using the CCFES system to assist them in practicing using
      their hand in activities such as lacing beads, throwing balls, eating finger foods, and other
      play and activities of daily living. Prior to the start of lab treatment, the investigators
      will assess hand extensor and flexor muscle co-activation (see below).

      Home sessions - These consist of CCFES-mediated hand opening and video game exercises with
      caregiver assistance and supervision as needed. As proficiency develops and more games are
      added, each home session will increase in duration up to 90 minutes per day, as determined by
      the treating therapist based on the adherence of each participant. Self report of game
      difficulty and engagement will be made at the completion of each game (see below)
    

Intervention name(s): Contralaterally-controlled functional electrical stimulation; Hand therapy video games
Intervention type(s): Device; Device
Intervention description(s): Contralaterally-controlled functional electrical stimulation (CCFES) is electrical stimulation of weak muscles of an impaired limb controlled via movement of the unimpaired contralateral limb.; Hand therapy video games are designed to provide therapy to weak muscles of an impaired limb via goal-directed movements.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hemiplegia; Functional Electrical Stimulation; Video Games; Occupational Therapy