MedTrace Logo

Contralaterally Controlled FES for Hand Opening in Hemiplegic Cerebral Palsy

NCT02925455 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-06-22

Study results available
· View outcomes & findings →

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

Interventions

DEVICE

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.

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.

Sponsors & Collaborators

  • The Cleveland Clinic

    collaborator OTHER

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

    collaborator NIH

  • MetroHealth Medical Center

    lead OTHER

Principal Investigators

  • Michael J Fu, PhD · MetroHealth Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-16
Primary Completion
2019-12-31
Completion
2020-04-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02925455 on ClinicalTrials.gov