MedTrace Logo

Effects of Functional Electrical Stimulation on Gait in Children With Cerebral Palsy

NCT02462018 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-06-03

No results posted yet for this study

Summary

Cerebral palsy (CP) is the most common neuromuscular disorder among children, resulting from a non-progressive injury during early brain development which leads to impairment of movement and posture.

Muscle weakness and spasticity associated with CP limit the joint range of motion and negatively impact ambulatory ability. Most ambulatory children with CP are prescribed with ankle-foot orthoses (AFOs) to improve ankle position and stability and to maintain muscle range. Nevertheless, AFOs may also restrict desired motions and may exacerbate muscle weakness and atrophy.

During the last years a novel method is being used for treating upper motor neuron drop foot, by means of dynamic orthoses, namely Functional Electrical Stimulation (FES).

These FES devices cause dorsiflexion of foot by stimulating the peroneal nerve and activating the tibialis anterior muscle. Most of the studies of FES devices were conducted on adult population. These studies showed improvement in laboratory and functional gait parameters. There are relatively few studies on children with hemiplegic or diplegic CP with favorable results. There is no solid evidence whether the improvements seen in laboratory setting of children with CP, are reflected on functional ambulation in daily life. In addition, there are no defined parameters which could predict the response to FES among those children.

The aim of this study is to determine whether using FES device (WalkAide; Innovative Neurotronics, Austin, TX, USA) improves daily motor function and gait parameters in children with spastic hemiplegic or diplegic CP. additionally, we aim to define clinical and biomechanical parameters that can predict a favorable response to using the FES device.

Conditions

  • Cerebral Palsy, Congenital
  • Muscle Spasticity

Interventions

DEVICE

WalkAide

Patiants with hemiplegic or asymmetric diplegic CP will use WalkAide device for 4 months .First month for adjustment and three months of daily using of the device. For each patient two assessments will be conducted: at baseline and at post-intervention follow-up. During the assessments each child will go through: A. Medical interview and neurological and physical therapist examination. B. Motor function tests: "6 min walk test", Gross motor function measure (GMFM) ,"Timed up and down stairs test" (TUDS), walking on a ramp ,with and without the FES device. C. Gait analysis test with and without FES device. D. Parents will be requested to complete questionnaires on the frequency of falling. E. On the second assessment parents wiil be requested to complete a questionnaire about the compliance to the FES.

Sponsors & Collaborators

  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-07-31
Completion
2017-07-31

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 NCT02462018 on ClinicalTrials.gov