Efficacy of Lower Extremity Mirror Therapy on Balance in Children With Hemiplegic Cerebral Palsy

January 9, 2020 updated by: Mohammed E. Ali, Ph. D Candidate., South Valley University

EFFICACY OF LOWER EXTREMITY MIRROR THERAPY ON BALANCE IN CHILDREN WITH HEMIPLEGIC CEREBRAL PALSY: A Randomized Controlled Trail

The study will be conducted to assess the efficacy of mirror therapy on balance in children with hemiplegic cerebral palsy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Hemiplegic cerebral palsy in the most common type of cerebral palsy that has permanent motor disorders and associated with life-long disability. the aim of study to assess the efficacy of mirror therapy on balance in children with hemiplegic cerebral palsy. Seventy child with hemiplegic cerebral were enrolled in this study and were assessed for eligibility. Their aged ranged from eight to twelve years. The children were assigned randomly into two equal groups. Group (a) control group received traditional physical therapy program. And group (b) study group received the same traditional physical therapy program in addition to mirror therapy three times / weak for three successful months. Biodex balance system was used to assess balance pre and post treatment. All children were assisted before and after three months of intervention.

Study Type

Interventional

Enrollment (Actual)

70

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
    • Qina
      • Qinā, Qina, Egypt, 83523
        • South Valley University, Faculty of Physical Therapy

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:

  • Children's aged ranged from eight to twelve years.
  • Children participated in this study will from both sexes.
  • Their degree of spasticity will ranged from mild to moderate according to Modified Ashworth Scale.
  • Children with stable medical and psychological status.
  • Children able to follow the verbal commands or instructions.

Exclusion Criteria:

  • children with visual or auditory problems.
  • Children with history of epilepsy.
  • Children with history of surgical interference in lower limbs less than one year.
  • Medically unstable children especially with cardiovascular disorders.
  • Mentally retarded children.
  • un-cooperative children.

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
No Intervention: the control group
Group (a) control group received traditional physical therapy program.
Experimental: the study group
group (b) study group received the same traditional physical therapy program in addition to mirror therapy three times / weak for three successful months.
Other: MIRROR THERAPY
The children were instructed to sitting on chair and a mirror is placed in midsagittal plane of the child, with the normal limb in front of mirror and the affected limb is blocked so the patient see only the reflected movement of the sound limb (non affected).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antro-posterior stability index
Time Frame: Antro-posterior stability index will be assessed at day 0.
the ability of child to maintain his balance from forward to backward direction
Antro-posterior stability index will be assessed at day 0.
Antro-posterior stability index
Time Frame: Antro-posterior stability index will be assessed at day 90.
the ability of child to maintain his balance from forward to backward direction
Antro-posterior stability index will be assessed at day 90.
Over All Stability Index
Time Frame: Over All Stability Index will be assessed at day 0.
the ability of child to maintain his balance in all directions
Over All Stability Index will be assessed at day 0.
Over All Stability Index
Time Frame: Over All Stability Index will be assessed at day 90.
the ability of child to maintain his balance in all directions
Over All Stability Index will be assessed at day 90.
Mediolateral Stability Index
Time Frame: Mediolateral Stability Index will be assessed at day 0.
the ability of child to maintain his balance from side to side directions
Mediolateral Stability Index will be assessed at day 0.
Mediolateral Stability Index
Time Frame: Mediolateral Stability Index will be assessed at day 90.
the ability of child to maintain his balance from side to side directions
Mediolateral Stability Index will be assessed at day 90.

Collaborators and Investigators

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

Sponsor

South Valley University

Investigators

  • Principal Investigator: Nehad A. Abo-zaid, PhD, South Valley University, Faculty of Physical Therapy
  • Principal Investigator: Mohammed E. Ali, PhD student, South Valley University, Faculty of Physical Therapy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 1, 2019

Primary Completion (Anticipated)

March 1, 2020

Study Completion (Anticipated)

March 31, 2020

Study Registration Dates

First Submitted

January 4, 2020

First Submitted That Met QC Criteria

January 9, 2020

First Posted (Actual)

January 13, 2020

Study Record Updates

Last Update Posted (Actual)

January 13, 2020

Last Update Submitted That Met QC Criteria

January 9, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/002575

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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