search
Back to results

The Effect of Functional Electrical Stimulation on Gait and Balance in Children With Hemiplegic Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Traditional Treatment
Sponsored by
Umm Al-Qura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

8 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Their weight should be less than 40 kg.
  • The spasticity degrees of the affected lower limb will range between grades (1, 1+ & 2) according to Modified Ashworth Scale (MAS).

Those children functioning scores at Gross Motor Function Classification System (GMFCS) Levels I and II.

  • They can walk 10 min conditionally without an orthosis.
  • Ought to be intellectually skilled and ready to comprehend and take after directions.
  • They will have neither serious nor recurring medical complications.
  • Children's height will be more than 100 cm to fit with the Biodex balance equipment that will be used in this study to evaluate balance performance.
  • No serious hip & knee flexion tightness will be present. Knee flexion at starting contact should be between 20-40º .
  • Peroneal nerve and the proximal leg muscles ought to be in place.
  • They ought to have no significant issues influencing balance other than spasticity.

Exclusion Criteria:

  • Children who demonstrate skin diseases or allergic reactions to adhesive tape or any other materials used in this study.
  • Children with visual, auditory or perceptual deficits.
  • Children with surgical interference for the lower limb.
  • Children with seizures or epilepsy.
  • Children who received botulinum toxin in the lower extremity musculature during the past 6 months or who wish to receive it within the period of study, other spasticity medication within 3 months of pre-treatment testing .
  • Children with pacemakers or other diseases that are contraindicated by electrical stimulation.

Sites / Locations

  • Maternity and Children Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traditional Treatment Arm

Functional Electrical Stimulation Group

Arm Description

Will receive conventional rehabilitation program for the lower limbs, balance and gait training. Two hours of conventional physical therapy program /session - 3 sessions/week/ three successive months.

Will receive 1.5 hours of conventional physical therapy program /session - 3 sessions weekly - three successive months + 1/2 hour of the gait training program with functional electrical stimulation /session - 3 sessions weekly - three successive months.

Outcomes

Primary Outcome Measures

Change from baseline spatial and temporal gait analysis at 3 months
Spatial and temporal gait analysis will be evaluated for every child at baseline and 3 months post-intervention using the Noraxon's Myo PRESSURE plate.
Change from baseline postural stability at 3 months
Postural stability will be evaluated at baseline and 3 months post-intervention using the Biodex Balance System (BBS) (Balance System SD, Shirely, NY, USA).

Secondary Outcome Measures

Full Information

First Posted
February 9, 2020
Last Updated
April 26, 2021
Sponsor
Umm Al-Qura University
search

1. Study Identification

Unique Protocol Identification Number
NCT04269798
Brief Title
The Effect of Functional Electrical Stimulation on Gait and Balance in Children With Hemiplegic Cerebral Palsy
Official Title
The Effect of Functional Electrical Stimulation Technology on Gait and Balance Performance in Children With Hemiplegic Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 11, 2020 (Actual)
Primary Completion Date
April 15, 2021 (Actual)
Study Completion Date
April 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umm Al-Qura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study will be to evaluate the effect of FES on stimulation of the anterior tibial group by using the WalkAide foot drop stimulator on improving walking and balance abilities in children with hemiplegic CP.
Detailed Description
The aim of this study will be to evaluate the effect of FES on improving walking and balance abilities in children with hemiplegic CP. Forty children with hemiplegic CP will be assigned randomly into two groups (A & B). Control group (A) will receive conventional rehabilitation program for lower limb, balance and gait training. Study group (B) will receive conventional rehabilitation program as in group (A) in addition to FES by using the WalkAide foot drop stimulator. Patients' evaluation will be carried out before and after training to assess walking ability and balance performance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional Treatment Arm
Arm Type
Active Comparator
Arm Description
Will receive conventional rehabilitation program for the lower limbs, balance and gait training. Two hours of conventional physical therapy program /session - 3 sessions/week/ three successive months.
Arm Title
Functional Electrical Stimulation Group
Arm Type
Experimental
Arm Description
Will receive 1.5 hours of conventional physical therapy program /session - 3 sessions weekly - three successive months + 1/2 hour of the gait training program with functional electrical stimulation /session - 3 sessions weekly - three successive months.
Intervention Type
Other
Intervention Name(s)
Traditional Treatment
Intervention Description
conventional rehabilitation program for lower limb, balance and gait training
Primary Outcome Measure Information:
Title
Change from baseline spatial and temporal gait analysis at 3 months
Description
Spatial and temporal gait analysis will be evaluated for every child at baseline and 3 months post-intervention using the Noraxon's Myo PRESSURE plate.
Time Frame
Baseline and 3 months post-intervention
Title
Change from baseline postural stability at 3 months
Description
Postural stability will be evaluated at baseline and 3 months post-intervention using the Biodex Balance System (BBS) (Balance System SD, Shirely, NY, USA).
Time Frame
Baseline and 3 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Their weight should be less than 40 kg. The spasticity degrees of the affected lower limb will range between grades (1, 1+ & 2) according to Modified Ashworth Scale (MAS). Those children functioning scores at Gross Motor Function Classification System (GMFCS) Levels I and II. They can walk 10 min conditionally without an orthosis. Ought to be intellectually skilled and ready to comprehend and take after directions. They will have neither serious nor recurring medical complications. Children's height will be more than 100 cm to fit with the Biodex balance equipment that will be used in this study to evaluate balance performance. No serious hip & knee flexion tightness will be present. Knee flexion at starting contact should be between 20-40º . Peroneal nerve and the proximal leg muscles ought to be in place. They ought to have no significant issues influencing balance other than spasticity. Exclusion Criteria: Children who demonstrate skin diseases or allergic reactions to adhesive tape or any other materials used in this study. Children with visual, auditory or perceptual deficits. Children with surgical interference for the lower limb. Children with seizures or epilepsy. Children who received botulinum toxin in the lower extremity musculature during the past 6 months or who wish to receive it within the period of study, other spasticity medication within 3 months of pre-treatment testing . Children with pacemakers or other diseases that are contraindicated by electrical stimulation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shamekh M El-Shamy, Ph.D.
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maternity and Children Hospital
City
Mecca
ZIP/Postal Code
149239
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Functional Electrical Stimulation on Gait and Balance in Children With Hemiplegic Cerebral Palsy

We'll reach out to this number within 24 hrs