Effect of Electrical Stimulation With Functional Task Training on Balance and Motor Abilities in Children With Diplegia

January 29, 2024 updated by: Randa Adel, Cairo University

Functional Task Training Combined With Electrical Stimulation on Balance and Motor Abilities in Children With Diplegia

The aims of the study are to:

  1. Investigate the combined effect of functional task training with electrical stimulation of bilateral hip abductor muscles on balance in children with diplegia.
  2. Investigate the combined effect of functional task training with electrical stimulation of bilateral hip abductor muscles on motor abilities in children with diplegia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cerebral palsy (CP) is a group of permanent disorders of movement and posture. It is non-progressive lesion or abnormality of immature brain. The term cerebral refers to the brain and palsy refers to the loss or impairment of motor function.

Functional electrical stimulation (FES) is a subtype of neuromuscular electrical stimulation (NMES) in which the stimulation assists functional and purposeful movements. This is achieved by applying electrical stimulation to muscles that, when they contract, produce a movement that can be used functionally.The FES is used to provide electrical stimulation via the peripheral nervous system to activate muscle contractions to assist functional activities when nervous or musculo-skeletal systems are damaged.The common applications of FES include strengthening muscle, reducing muscle spasticity, increasing range of motion, improving upper extremity function and walking speed.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • El-beheira
      • Ītāy Al Bārūd, El-beheira, Egypt
        • ‪Randa Adel‬

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Their ages will range from 7-11 years.
  • Both genders will be included.
  • Their degree of spasticity will range from 1 to 1+ according to Modified Ashworth Scale (Meseguer-Henarejos et al., 2018).
  • Their motor function will be at level I & II according to Gross Motor Function --- -Classification system (Palisano et al., 2008).
  • They will be understanding instructions.

Exclusion Criteria:

  • Children will be excluded from the study if they have any of the following criteria:

Musculoskeletal fixed deformities in upper limb, lower limb or spine.

  • Visual or hearing problems.
  • Epilepsy.
  • Botulinium toxin therapy or orthopedic surgery within the past 6months or within the study period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control group had functional task training
this group doing functional task training exercise for 50 min 3 times per week for two months
Other: functional task training
functional exercise
Experimental: study group had functional task training combined with electrical stimulation
this group doing functional task training exercise combined with electrical stimulation for 50 min 3 times per week for two months
Other: functional task training
functional exercise
Device: functional electrical stimulation
electrical stimulation during function

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Humac balance system
Time Frame: two months
static and dynamic balance when values inscrease the results are better.
two months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Growth motor functional scale
Time Frame: two months
measuring motor abilities standing and walking when values increase the results are better.
two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: ‪Randa Adel‬, master, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2023

Primary Completion (Actual)

September 12, 2023

Study Completion (Actual)

November 25, 2023

Study Registration Dates

First Submitted

January 5, 2024

First Submitted That Met QC Criteria

January 29, 2024

First Posted (Estimated)

January 31, 2024

Study Record Updates

Last Update Posted (Estimated)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E.S and balance in diplegia

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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