Virtual Reality Training Using Wii Fit in Children With Cerebral Palsy (VR in CP)

April 16, 2026 updated by: Ziauddin University

EFFECTS OF VIRTUAL REALITY TRAINING USING WII FIT ON BALANCE, GROSS MOTOR FUNCTION, AND AGILITY IN CHILDREN WITH CEREBRAL PALSY -A RANDOMIZED CONTROLLED TRIAL

The goal of this clinical trial is to determine whether virtual reality (VR) training using the Nintendo Wii Fit can improve balance, gross motor function, and agility in children aged 7-14 years with spastic cerebral palsy (GMFCS Levels I-II). The main questions it aims to answer are:

Does Wii Fit-based VR training improve balance more than conventional physiotherapy?

Does VR training enhance gross motor skills such as standing, walking, running, and jumping?

Does VR training improve agility in children with cerebral palsy?

Does VR training increase enjoyment and engagement during therapy?

Researchers will compare Wii Fit-based VR training with conventional physiotherapy to determine which approach leads to greater improvements in motor function.

Participants will:

Attend 18 sessions over 6 weeks (3 sessions per week).

Perform either VR-based exercises using the Wii Fit Balance Board or traditional physiotherapy exercises.

Complete pre- and post-intervention assessments using the Pediatric Balance Scale, GMFM-88 (domains D and E), BOT-2 agility subtest, and the PACES enjoyment scale.

This study aims to explore a fun, cost-effective, and engaging rehabilitation strategy that may improve functional independence and overall quality of life for children with cerebral palsy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This clinical trial aims to evaluate the effects of virtual reality training using the Nintendo Wii Fit on balance, gross motor function, agility, and enjoyment in children with spastic cerebral palsy. Cerebral palsy commonly affects motor control, posture, coordination, and mobility, and children often require long-term physiotherapy to improve their functional independence. While traditional physiotherapy is effective, many children struggle with motivation, participation, and engagement during repetitive therapeutic exercises. Virtual reality-based interventions are emerging as a fun, interactive, and affordable way to increase motivation and enhance motor learning in pediatric rehabilitation.

In this study, children aged 7 to 14 years with spastic cerebral palsy (GMFCS Levels I-II) will be randomly assigned to either Wii Fit-based virtual reality training or conventional physiotherapy. The intervention will last 6 weeks, with sessions held three times per week. The virtual reality group will perform selected Wii Fit games that specifically target balance, coordination, strength, motor planning, and agility. These include Table Tilt, Balance Bubble, Perfect 10, Super Hula Hoop, Obstacle Course, Ultimate Obstacle Course, Ski Jump, and Basic Step. Each session consists of a warm-up phase, 20 minutes of Wii Fit gameplay, and a cool-down period. Game difficulty will progressively increase as the child's performance improves, while therapists will ensure safety and provide encouragement.

The control group will receive conventional physiotherapy, which includes strengthening exercises, gait training, dynamic and static balance tasks, and functional task-oriented activities. Both groups will receive an equal number of sessions with similar session duration to ensure fairness in comparison.

Outcome measures include the Pediatric Balance Scale (balance), GMFM-88 domains D and E (standing, walking, running, jumping), BOT-2 Running Speed and Agility Subtest (agility), and the Physical Activity Enjoyment Scale. Assessments will be conducted before and after the 6-week intervention by trained assessors who are blinded to group allocation.

This study aims to address the lack of comprehensive research evaluating the combined effects of virtual reality on multiple motor skills in children with cerebral palsy, particularly in Pakistan. By comparing Wii Fit training with conventional physiotherapy, the study seeks to determine whether VR offers a more engaging, motivating, and effective rehabilitation option. If successful, the findings may support the use of low-cost, accessible virtual reality tools in pediatric therapy settings to improve functional outcomes, engagement, and quality of life for children with cerebral palsy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Ghulam Sakina Awan, MPhil in Physical Therapy
  • Phone Number: 5 021-36629251
  • Email: Ghulam.18567@zu.edu.pk

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ● Children aged 7 to 14 years

    • Diagnosed cases of spastic diplegic CP, characterized by bilateral lower limb involvement
    • Classified under GMFCS levels I to II.
    • Having mild to moderate spasticity on Modified Ashworth Scale (MAS) scores ranging from 1, +1 or 2
    • Mild level intellectual disability according to their health records
    • Medically stable with no acute illness or uncontrolled comorbidities
    • No major changes in medication or therapy planned during the study period.

Exclusion Criteria:

  • ● Orthopedic surgery or botulinum toxin injections in the past 16 months

    • Hearing or visual impaired .
    • Uncontrolled epilepsy or seizures
    • Severe attention deficits or psychological issues interfering with task engagement such as attention deficit hyperactivity disorder (ADHD), Autism Spectrum Disorder (ASD) will be excluded from the study .

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: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Virtual Reality Group
Participants in this group will receive Wii Fit-based virtual reality training using the Nintendo Wii Fit Balance Board. Each session will include a warm-up, 20 minutes of structured Wii Fit gameplay, and a cool-down. The selected games target balance, coordination, strength, and agility, such as Table Tilt, Balance Bubble, Perfect 10, Super Hula Hoop, Obstacle Course, Ultimate Obstacle Course, Ski Jump, and Basic Step. Difficulty levels will progress gradually based on the participant's performance. Sessions will be conducted three times per week for six weeks (total 18 sessions), supervised by a physiotherapist. No additional physiotherapy exercises will be given during the intervention period.
Device: Experimental Group
Participants in this group will receive Wii Fit-based virtual reality training using the Nintendo Wii Fit Balance Board. Each session will include a warm-up, 20 minutes of structured Wii Fit gameplay, and a cool-down. The selected games target balance, coordination, strength, and agility, such as Table Tilt, Balance Bubble, Perfect 10, Super Hula Hoop, Obstacle Course, Ultimate Obstacle Course, Ski Jump, and Basic Step. Difficulty levels will progress gradually based on the participant's performance. Sessions will be conducted three times per week for six weeks (total 18 sessions), supervised by a physiotherapist. No additional physiotherapy exercises will be given during the intervention period.
Placebo Comparator: Conventional Physical Therapy
Participants assigned to the control group will receive routine physiotherapy commonly used for children with cerebral palsy. This includes strengthening exercises, stretching, balance training, gait training, coordination tasks, and functional activity practice. Each session will follow the same overall duration and format as the intervention group (warm-up, 20-minute main exercise phase, and cool-down). Sessions will also be conducted three times per week for six weeks (total 18 sessions), supervised by a physiotherapist. No virtual reality activities will be provided.
Behavioral: control group
Participants assigned to the control group will receive routine physiotherapy commonly used for children with cerebral palsy. This includes strengthening exercises, stretching, balance training, gait training, coordination tasks, and functional activity practice. Each session will follow the same overall duration and format as the intervention group (warm-up, 20-minute main exercise phase, and cool-down). Sessions will also be conducted three times per week for six weeks (total 18 sessions), supervised by a physiotherapist. No virtual reality activities will be provided.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Gross Motor Skills
Time Frame: Baseline
Gross Motor Skills measured via GMFM-88 (domains D and E)
Baseline
Balance
Time Frame: Baseline
Balance measured via Pediatric Balance Scale (PBS)
Baseline
Agility
Time Frame: Baseline
Agility using the running speed and agility subset of Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)
Baseline
Agility
Time Frame: 6 weeks
Agility using the running speed and agility subset of Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)
6 weeks
Balance
Time Frame: 6 weeks
Balance measured via Pediatric Balance Scale (PBS)
6 weeks
Gross Motor Skills
Time Frame: 6 weeks
Gross Motor Skills measured via GMFM-88 (domains D and E)
6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Level of enjoyment
Time Frame: 6 weeks
Level of enjoyment using the Physical Activity Enjoyment Scale (PACES)
6 weeks
Level of enjoyment
Time Frame: Baseline
Level of enjoyment using the Physical Activity Enjoyment Scale (PACES)
Baseline

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ziauddin 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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 25, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10980825GSPT (Other Identifier: Ziauddin University)

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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