Contralaterally Controlled FES for Hand Opening in Hemiplegic Cerebral Palsy

Study Overview
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Brief Summary
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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
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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)

Official Title
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Contralaterally Controlled Functional Electrical Stimulation for Hand Opening in Hemiplegic Cerebral Palsy: Pilot Randomized Controlled Trial

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Device: Contralaterally-controlled functional electrical stimulation
* Device: Hand therapy video games


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Upper Extremity hemiparesis from Cerebral Palsy Age 6-17 Caregiver can transport participant to weekly sessions and assist with home treatment Medically stable; stable medications Recall 2 of 3 items after 30 min Finger extension strength ≤ 4/5 on paretic side Able to follow 3-stage commands Adequate active movement of paretic arm to position the hand for table-top task practice Skin intact on hemiparetic arm Surface neuromuscular electrical stimulation trial opens hand without pain Full volitional hand opening and closing of contralateral hand Box & Blocks Score of weaker side < 90% of stronger side score Able to hear and respond to auditory cues English proficiency of both caregiver and child Exclusion Criteria: Uncontrolled seizure disorder Co-existing neurological conditions other than cerebral palsy affecting the hemiparetic upper limb (e.g., peripheral nerve injury, Parkinson's disease, spinal cord injury, traumatic brain injury, multiple sclerosis, stroke, hemispherectomy) Severely impaired cognition and communication History of cardiac arrhythmias with hemodynamic instability Insensate arm, forearm, or hand Uncompensated hemi-neglect Cardiac pacemaker or any other implanted electronic systems Pregnant Intramuscular Botox injections in any upper extremity muscle in the last 3 months Severe visual impairment

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stimulation + Video Games<br>Contralaterally-controlled functional electrical stimulation (CCFES) enables patients with upper extremity hemiplegia to open their paretic hand by stimulating finger and thumb extensors with surface electrodes. CCFES is used during functional task practice and hand therapy video games to link motor intent with execution. Four intuitive and engaging games were developed to provide goal-oriented motor skill training, impairment-appropriate difficulty, and performance feedback that motivates iterative play and skill improvement. | Device: Contralaterally-controlled functional electrical stimulation<br>* Contralaterally-controlled functional electrical stimulation (CCFES) is electrical stimulation of weak muscles of an impaired limb controlled via movement of the unimpaired contralateral limb.<br>Device: Hand therapy video games<br>* Hand therapy video games are designed to provide therapy to weak muscles of an impaired limb via goal-directed movements.<br>|
| Active Comparator: Video Games (no stimulation)<br>Participants receive duration-matched, identical hand therapy video games and task practice therapy as the experiment arm, but do not receive CCFES to assist hand opening. | Device: Hand therapy video games<br>* Hand therapy video games are designed to provide therapy to weak muscles of an impaired limb via goal-directed movements.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Assisting Hands Assessment Logit Score at End of Treatment | Participants played a game that required them to perform bimanual tasks while being video recorded. The amount of involvement of the affected arm is scored by viewing the video and converted into a logit score (0-100), with a higher value indicating a better outcome. | 2 time points: prior to treatment and at end of 6 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Melbourne 2 Motor Assessment at End of Treatment | Participants perform 14 test tasks that require reach, grasp, release, and manipulation of simple objects. A video of the test is recorded for scoring across the 30 score items using a three, four or five point scale (higher values indicating better outcomes). Item scores relating to four elements of movement are measured and summed within the corresponding sub-scale. A percentage of the total score (range 0-100%) for each subscale is computed and reported separately, with higher values indicating better outcomes. | 2 time points: prior to treatment and at end of 6 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemiplegia, Functional Electrical Stimulation, Video Games, Occupational Therapy