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NCT Number: NCT04269798

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

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

8 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maternity and Children Hospital

Mecca, 149239, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

traditional treatment

Other

conventional rehabilitation program for lower limb, balance and gait training

Primary outcomes

  1. Change from baseline spatial and temporal gait analysis at 3 months

    Time frame: 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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Umm Al-Qura University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 17, 2020
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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