Virtual Reality Versus Mirror Therapy on Balance and Muscle Strength in Children With Hemiplegic Cerebral Palsy

April 13, 2022 updated by: samar salem, October 6 University

Previous research has demonstrated balance deficits ranging from 28%-43% depending on the nature of the balance task in individuals with CP compared to controls (Kenis-Coskun et al., 2016). As balance is critical for underlying normal movement, improvements in static and dynamic balance are important goals in rehabilitation for ambulatory children with CP (Saether et al., 2013).

Balance deficits are among the symptoms that having a more profound impact on motor function and quality of life inn with CP children (Lai et al., 2017). Poor balance reduces the ability to perform gait-related activities and increases the risk of falling, which, in turn, limits participation in daily activities, including sports and physical activities (Usuba et al., 2015).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

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
    • October
      • Cairo, October, Egypt, 8124

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

6 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Their ages will range from 6 to 10 years old.
  • The degree of spasticity will range from 1+ to 2 grades according to Modified Ashworth scale (NUMANO and Günel, 2011) (Appendix II).
  • They will be on level I and II on Gross Motor Function Classification System (GMFCS) (Palisano et al., 2008) (Appendix III).
  • Their heights will be one meter or more.
  • They will be able to follow the verbal commands or instructions.

Exclusion Criteria:

  • Severe visual or auditory problems.
  • Epilepsy.
  • History of surgical interference in lower limbs.
  • Botulinum toxin injections of the lower limbs during the previous six

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
Experimental: group A
will receive a designed physical therapy program in addition to program of virtual reality
Other: designed physical therapy program in addition to program of virtual reality.
physical therapy program in addition to program of virtual reality.
Experimental: group B
will receive a designed physical therapy program in addition to program of mirror therapy.
Other: designed physical therapy program in addition to program of mirror therapy.
physical therapy program in addition to program of mirror therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biodex balance system
Time Frame: 3 months
The Biodex balance System to measures postural stability under dynamic stress.
3 months
Hand held dynamometer
Time Frame: 3 months
The hand held dynamometry to measure muscle strength of non-disabled children
3 months

Collaborators and Investigators

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

Sponsor

October 6 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 (Anticipated)

December 22, 2022

Primary Completion (Anticipated)

March 22, 2023

Study Completion (Anticipated)

December 22, 2023

Study Registration Dates

First Submitted

March 28, 2022

First Submitted That Met QC Criteria

April 13, 2022

First Posted (Actual)

April 18, 2022

Study Record Updates

Last Update Posted (Actual)

April 18, 2022

Last Update Submitted That Met QC Criteria

April 13, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/0035A342

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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