CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 15 enrolled
Drug / intervention
Contralaterally-controlled functional electrical stimulation +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02925455
NCT02925455N/ACompleted

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

MetroHealth Medical Center·interventional·Posted Oct 5, 2016·Updated Jun 22, 2021

In Brief

A clinical study evaluating Contralaterally-controlled functional electrical stimulation and Hand therapy video games for Cerebral Palsy. Completed, enrolled 15 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCerebral Palsy
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedOct 5, 2016
Enrollment StartOct 16, 2016
Primary CompletionDec 31, 2019
Study CompletionApr 30, 2020
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 9.7 years ago

Interventions

Contralaterally-controlled functional electrical stimulationdevice

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 gamesdevice

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