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Completed

NCT Number: NCT06303440

Effects of Virtual Reality Versus Motor Imagery 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.

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Key information

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah International University

Lahore, Punjab Province, 54660, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Routine Physical Therapy+ Balance Training

Other

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.

Virtual Reality+ Routine Physical Therapy

Other

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.

Motor Imagery+ Routine Physical Therapy

Other

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.

Primary outcomes

  1. Gross Motor Function Classification System

    Time frame: 12 weeks

    Gross Motor Function Classification System will be used to measure balance

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 12, 2024
Registry last updated
Oct 28, 2024

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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