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

• Sponsor: Umm Al-Qura University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04269798
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.1
• Patients Per Site Per Month: 2.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Palsy	Other: Traditional Treatment	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effect of Functional Electrical Stimulation Technology on Gait and Balance Performance in Children With Hemiplegic Cerebral Palsy
• Actual Study Start Date: Feb 11, 2020
• Actual Primary Completion Date: Apr 15, 2021
• Actual Study Completion Date: Apr 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Traditional Treatment Arm 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.	Other: Traditional Treatment; conventional rehabilitation program for lower limb, balance and gait training
Experimental: Functional Electrical Stimulation Group 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.	Other: Traditional Treatment; conventional rehabilitation program for lower limb, balance and gait training

Outcome Measures

Primary Outcome Measures

1. Change from baseline spatial and temporal gait analysis at 3 months [Baseline and 3 months post-intervention]

   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.

2. Change from baseline postural stability at 3 months [Baseline and 3 months post-intervention]

   Postural stability will be evaluated at baseline and 3 months post-intervention using the Biodex Balance System (BBS) (Balance System SD, Shirely, NY, USA).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 10 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Their weight should be less than 40 kg.

• The spasticity degrees of the affected lower limb will range between grades (1, 1+ &

1. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maternity and Children Hospital	Mecca		Saudi Arabia	149239

Sponsors and Collaborators

• Umm Al-Qura University

Investigators

• Principal Investigator: Shamekh M El-Shamy, Ph.D., Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shamekh Mohamed El-Shamy, Professor, Umm Al-Qura University
• ClinicalTrials.gov Identifier: NCT04269798
• Other Study ID Numbers: Umm AlQura University
• First Posted: Feb 17, 2020
• Last Update Posted: Apr 28, 2021
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cerebral Palsy

Study Results

No Results Posted as of Apr 28, 2021