Effects of Virtual Reality Versus Motor Imagery in Children With Cerebral Palsy

October 25, 2024 updated by: Riphah International University

Effects of Virtual Reality Versus Motor Imagery on Balance, Gross Motor Function and Activities of Daily Living in Children With Cerebral Palsy.

Cerebral palsy is a neurodevelopmental disorder caused by brain injury that appears in infancy, children have mostly issues of gross motor functions, and activities of daily living. Virtual Reality is an innovative technique for the improvement of balance and motor function in most of the neurological conditions. Motor Imagery is an ability to engage in the mental representation of a task consciously without generating a voluntary movement. The aim of this study is to determine the comparative effects of Virtual Reality and Motor Imagery on balance, gross motor function and activities of daily living in children with cerebral palsy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This randomized controlled trial will be conducted at Rising Sun Institute. The sample size calculated for this trial will be 75. The participants will be randomly allocated using online randomization tool into three groups; Group A will receive routine physical therapy (PT) for 30 minutes with additional selected exercises for 15 minutes, Group B will receive VR training for 15 minutes with routine PT for 30 minutes, and Group C will receive MI for 15 minutes and routine PT for 30 minutes. Each participant will receive treatment for three days on alternative days per week for 12 weeks. Gross Motor Function Scale (GMFCS) will be used for balance, Bruininks-Oseretsky Test of motor function Proficiency-2 (BOT-2 ) for motor function, and WeeFIM scale for ADLs at baseline, 8th week, 12th week, and at 16th week after discontinuation of treatment.

Study Type

Interventional

Enrollment (Actual)

63

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

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54660
        • Riphah International University

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:

Children of 7-12 years of both genders, Children with Mini Mental Scale score >24.

Children with Gross motor function classification system (GMFCS) level I and II and able to follow and accept verbal instruction.

Exclusion Criteria: History of any Visual and Hearing Impairments, Virtual game phobia.

History of nerve, muscle, bone and joint diseases that seriously affect the movement function of the limbs and Children with history of severe cardiopulmonary disease, History of epilepsy, History of Fixed deformity of Lower limb. History of orthopaedic surgery and botulinum toxin injection.

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
Other: Group A (Routine Physical Therapy+ Balance Training)

The children will be provided with Routine Physical Therapy and Balance Training.

Balance exercises will be provided for 15 minutes and 30 minutes of Routine physical therapy will be as strengthening and stretching exercises.
Other: Routine Physical Therapy+ Balance Training
Each session will be begun with routine PT treatment and lasted for 45 minutes in total. To start, the participants will be asked to do warm-up exercises, sitting comfortably on a chair with their backs and feet well supported, the participants will be instructed to breathe in and out. Warm-up exercises will be carried out for 5 minutes. Stretching exercises will be performed for 15 minutes per session, and stretches were held for 30 seconds with four repetitions of each of the following areas, shoulder flexors, elbow and wrist flexors, hip flexors, hip adductors, knee flexors, and calf, 10 seconds of rest period will be added after stretching of one muscle group. Participants will have a 15 minutes session of exercises neck holding on form roller for 1 minute with two repetitions, astride-sitting on foam roller for 2 minutes with four repetitions, weight on both hands on gym ball for 1 minute with two repetitions and hip adductors strengthening for 1 minute with three repetitions.
Experimental: Group B (Virtual Reality + Routine Physical Therapy)
The VR system consisted of a wall-mounted display, a Nintendo Wii box, a Wii remote, and a Wii Fit board. The participants will be instructed to stand on Wii Fit board while interacting with the VR system and playing the selected games and routine physical therapy of 30 minutes will be provided.
Other: Virtual Reality+ Routine Physical Therapy
The exercises will be selected, and the difficulty level will be gradually increased according to participant's performance. Starting from the penguin slide, they will progress to table tilt. Initially, each game will be played for 2 minutes per session. With the progression of performance, 4 minutes of table tilt will be added. While playing this game, a typical mobility pattern will be initiated, and balance will be improved. In the same week, the subjects performed single-leg extensions for 1 minutes. In the following weeks, Balance Bubble, Advanced step, and Basic Run will be added to the plan. The participants will perform these activities for 7 minutes per session. Treatment sessions then progressed to motor function games, including bowling, tennis, kicking, and boxing (least challenging to most challenging), with most treatment sessions ending with boxing will be provided for 7 minutes and routine physical therapy for 30 minutes as explained in control group.
Experimental: Group C (Motor Imagery+ Routine Physical Therapy)
During the presentation of a video clip, patients will watch the video and afterwards try to do movement as same as shown in video
Other: Motor Imagery+ Routine Physical Therapy

The 15 minutes of Motor Imagery session will be provided to participants. It's a three step process that will be used to incorporate the technique.

Step I, The self-recorded videos of the principal researcher performing a normal movements will be shown to participant.

Step II, The participants will be asked to imagine movement with eyes closed, and breathe deeply.

Step III The participants will be asked to perform the movement you watched in video and routine physical therapy of 30 minutes will be provided.

During the presentation of a video clip, patients will watch the video and afterwards try to do movement as same as shown in video.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gross Motor Function Classification System
Time Frame: 12 weeks
Gross Motor Function Classification System will be used to measure balance
12 weeks
Bruininks-Oseretsky Test of motor function Proficiency-2
Time Frame: 12 Weeks
It will be measured with Bruininks-Oseretsky Test of motor function Proficiency-2 for motor function.
12 Weeks
Functional Independence Measure for Children
Time Frame: 12 Weeks
Functional Independence Measure for Children scale will be used to determine the Activities of Daily Living improvement.
12 Weeks

Collaborators and Investigators

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

Sponsor

Riphah International University

Investigators

  • Study Chair: Muhammad Kashif, PhD-PT, Riphah International University

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)

February 25, 2024

Primary Completion (Actual)

August 31, 2024

Study Completion (Actual)

August 31, 2024

Study Registration Dates

First Submitted

March 4, 2024

First Submitted That Met QC Criteria

March 4, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

October 28, 2024

Last Update Submitted That Met QC Criteria

October 25, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR&AHS/23/0288

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

product manufactured in and exported from the U.S.

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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