Clinical trial NCT02925455: Contralaterally Controlled FES for Hand Opening in Hemiplegic Cerebral Palsy
Official title: Contralaterally Controlled Functional Electrical Stimulation for Hand Opening in Hemiplegic Cerebral Palsy: Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Hemiplegia
Functional Electrical Stimulation
Video Games
Occupational Therapy
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
Collaborators: name: The Cleveland Clinic
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2016-10-05
Enrollment: 15
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)

Eligibility criteria: 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

Primary outcomes:
measure: Change in Assisting Hands Assessment Logit Score at End of Treatment
timeFrame: 2 time points: prior to treatment and at end of 6 weeks of treatment
Secondary outcomes:
measure: Change in Melbourne 2 Motor Assessment at End of Treatment
timeFrame: 2 time points: prior to treatment and at end of 6 weeks of treatment
Other outcomes:
measure: Change in Box and Block Test Score at Treatment End
timeFrame: 2 time points: prior to treatment and after 6 weeks of treatment
measure: Change in Instrumented Sine Wave Finger Tracking Error at Treatment End
timeFrame: 2 time points: prior to treatment start and at end of treatment week 6.
measure: Number of Cumulative Hand Movement Repetitions During Game Play
timeFrame: 6 weeks
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
Study officials:
affiliation: MetroHealth Medical Center
name: Michael J Fu, PhD
role: PRINCIPAL_INVESTIGATOR
References: