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NCT Number: NCT05020834

Effect of Functional Electrical Stimulation Versus TheraTogs on Treatment of Children With Hemiplegic Cerebral Palsy.

To compare the effect of functional electrical stimulation (FES) versus TheraTogs on Gait and Balance 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, 715, Saudi Arabia

About this study

The aim of this study was to evaluate the effect of FES versus TheraTogs on Gait and Balance in children with hemiplegic CP. Thirty children with hemiplegic CP will be assigned randomly into two groups (A & B). Group A received FES by using the WalkAide foot drop stimulator while group B received TheraTogs. Patients' evaluation will be carried out before and after training to assess gait and balance performance.

Who can participate

Healthy volunteers accepted: No

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

Functional Electrical Stimulation

Other

Functional Electrical Stimulation Group received 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.

TheraTogs Orthotic Undergarment

Other

TheraTogs Arm The participating children worn TheraTogs orthotic undergarment and strapping as preparatory stage without application of any exercise program with gradually increasing the worn time till reaching the 8 hours per day.

Primary outcomes

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

    Time frame: Baseline and 3 months post-intervention

    Gait parameters were evaluated for every child at baseline and 3 months post-intervention using the Pro-Reflex motion analysis system (Qualisys; Qualisys Inc, Goeteborg, Sweden). For the purpose of this study four commonly used and reliable gait parameters were examined: stride length, step length, velocity, cadence, and stance and swing phase percentage.

  2. Change from baseline postural stability at 3 months

    Time frame: Baseline and 3 months post-intervention

    Postural stability were 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

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 25, 2021
Registry last updated
Aug 25, 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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