Contralaterally Controlled FES for Hand Opening in Hemiplegic Cerebral Palsy

NCT ID: NCT02925455

Last Updated: 2021-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-16
• Study Completion Date: 2020-04-30

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)

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Stimulation + Video Games

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.

Group Type: EXPERIMENTAL

Contralaterally-controlled functional electrical stimulation

Intervention Type: DEVICE

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

Intervention Type: DEVICE

Hand therapy video games are designed to provide therapy to weak muscles of an impaired limb via goal-directed movements.

Video Games (no stimulation)

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.

Group Type: ACTIVE_COMPARATOR

Hand therapy video games

Intervention Type: DEVICE

Hand therapy video games are designed to provide therapy to weak muscles of an impaired limb via goal-directed movements.

Interventions

Contralaterally-controlled functional electrical stimulation

Contralaterally-controlled functional electrical stimulation (CCFES) is electrical stimulation of weak muscles of an impaired limb controlled via movement of the unimpaired contralateral limb.

Intervention Type: DEVICE

Hand therapy video games

Hand therapy video games are designed to provide therapy to weak muscles of an impaired limb via goal-directed movements.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

MetroHealth Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Michael Fu

Assistant Professor, Physical Medicine and Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael J Fu, PhD

Role: PRINCIPAL_INVESTIGATOR

MetroHealth Medical Center

Locations

Cleveland Clinic Foundation

Cleveland, Ohio, United States

MetroHealth Medical Center

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R21HD088987-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

16-400

Identifier Type: -

Identifier Source: org_study_id