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

NCT04269798 | Completed DMC

• 1 other identifier: Umm AlQura University
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline and 3 months post-intervention

• 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).

  Baseline and 3 months post-intervention

Study Arms (2)

Traditional Treatment Arm

ACTIVE COMPARATOR

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

Functional Electrical Stimulation Group

EXPERIMENTAL

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

Interventions

Traditional Treatment OTHER

conventional rehabilitation program for lower limb, balance and gait training

Functional Electrical Stimulation Group; Traditional Treatment Arm

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Umm Al-Qura University: lead

Study Sites (1)

Maternity and Children Hospital

Mecca, 149239, Saudi Arabia

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Shamekh M El-Shamy, Ph.D.

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 9, 2020
• First Posted: February 17, 2020
• Study Start: February 11, 2020
• Primary Completion: April 15, 2021
• Study Completion: April 15, 2021
• Last Updated: April 28, 2021

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)