Contralaterally Controlled FES for Hand Opening in Hemiplegic Cerebral Palsy

NCT02925455 | Completed Results

• 2 other identifiers: 16-4001R21HD088987-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

Cerebral Palsy

Keywords

Hemiplegia; Functional Electrical Stimulation; Video Games; Occupational Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Melbourne 2 Motor Assessment at End of Treatment

  2 time points: prior to treatment and at end of 6 weeks of treatment

Other Outcomes (3)

• Change in Box and Block Test Score at Treatment End

  2 time points: prior to treatment and after 6 weeks of treatment

• Change in Instrumented Sine Wave Finger Tracking Error at Treatment End

  2 time points: prior to treatment start and at end of treatment week 6.

• Number of Cumulative Hand Movement Repetitions During Game Play

  6 weeks

Study Arms (2)

Stimulation + Video Games

EXPERIMENTAL

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; Device: Hand therapy video games

Video Games (no stimulation)

ACTIVE COMPARATOR

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

Interventions

Contralaterally-controlled functional electrical stimulation 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.

Stimulation + Video Games

Hand therapy video games DEVICE

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

Stimulation + Video Games; Video Games (no stimulation)

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MetroHealth Medical Center: lead
• The Cleveland Clinic: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

Cleveland Clinic Foundation

Cleveland, Ohio, 44104, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

MeSH Terms

Conditions

Cerebral Palsy; Hemiplegia

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Michael Fu
• Organization: Case Western Reserve University and MetroHealth System

mjf24@case.edu

215-368-0355

Study Officials

• Michael J Fu, PhD

  MetroHealth Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: October 3, 2016
• First Posted: October 5, 2016
• Study Start: October 16, 2016
• Primary Completion: December 31, 2019
• Study Completion: April 30, 2020
• Last Updated: June 22, 2021
• Results First Posted: June 22, 2021

Record last verified: 2021-06

Locations

US (2)