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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04269798
• Other study ID #: Umm AlQura University
• Status: Completed
• Phase: N/A
• Start date: February 11, 2020
• Est. completion date: April 15, 2021

Study information

• Verified date: February 2020
• Source: Umm Al-Qura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 15, 2021
• Est. primary completion date: April 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 10 Years

Eligibility

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 Classi?cation 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.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Other:
• Traditional Treatment
conventional rehabilitation program for lower limb, balance and gait training

Locations

Country	Name	City	State
Saudi Arabia	Maternity and Children Hospital	Mecca

Sponsors (1)

Lead Sponsor	Collaborator
Umm Al-Qura University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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