- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07547644
Virtual Reality Training Using Wii Fit in Children With Cerebral Palsy (VR in CP)
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
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ghulam Sakina Awan, MPhil in Physical Therapy
- Phone Number: 5 021-36629251
- Email: Ghulam.18567@zu.edu.pk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
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
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
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
Sponsor
Publications and helpful links
General Publications
- Chen Y, Fanchiang HD, Howard A. Effectiveness of Virtual Reality in Children With Cerebral Palsy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Phys Ther. 2018 Jan 1;98(1):63-77. doi: 10.1093/ptj/pzx107.
- Behm DG, Chaouachi A. A review of the acute effects of static and dynamic stretching on performance. Eur J Appl Physiol. 2011 Nov;111(11):2633-51. doi: 10.1007/s00421-011-1879-2. Epub 2011 Mar 4.
- Venema DM, Skinner AM, Nailon R, Conley D, High R, Jones KJ. Patient and system factors associated with unassisted and injurious falls in hospitals: an observational study. BMC Geriatr. 2019 Dec 11;19(1):348. doi: 10.1186/s12877-019-1368-8.
- Paul S, Nahar A, Bhagawati M, Kunwar AJ. A Review on Recent Advances of Cerebral Palsy. Oxid Med Cell Longev. 2022 Jul 30;2022:2622310. doi: 10.1155/2022/2622310. eCollection 2022.
- Ziab H, Saleh S, Talebian S, Olyaei G, Mazbouh R, Sarraj AR, Hadian MR. Effectiveness of virtual reality training compared to balance-specific training and conventional training on balance and gross motor functions of children with cerebral palsy: A double blinded randomized controlled trial. J Pediatr Rehabil Med. 2024 Sep;17(3):353-368. doi: 10.3233/PRM-220120.
- Esculier JF, Vaudrin J, Beriault P, Gagnon K, Tremblay LE. Home-based balance training programme using Wii Fit with balance board for Parkinsons's disease: a pilot study. J Rehabil Med. 2012 Feb;44(2):144-50. doi: 10.2340/16501977-0922.
- Deutsch JE, Borbely M, Filler J, Huhn K, Guarrera-Bowlby P. Use of a low-cost, commercially available gaming console (Wii) for rehabilitation of an adolescent with cerebral palsy. Phys Ther. 2008 Oct;88(10):1196-207. doi: 10.2522/ptj.20080062. Epub 2008 Aug 8.
- Damiano DL. Activity, activity, activity: rethinking our physical therapy approach to cerebral palsy. Phys Ther. 2006 Nov;86(11):1534-40. doi: 10.2522/ptj.20050397.
- Chidi-Egboka NC, Jalbert I, Golebiowski B. Smartphone gaming induces dry eye symptoms and reduces blinking in school-aged children. Eye (Lond). 2023 May;37(7):1342-1349. doi: 10.1038/s41433-022-02122-2. Epub 2022 Jun 6.
- Bonnechere B, Jansen B, Omelina L, Van Sint Jan S. The use of commercial video games in rehabilitation: a systematic review. Int J Rehabil Res. 2016 Dec;39(4):277-290. doi: 10.1097/MRR.0000000000000190.
- Bekteshi S, Monbaliu E, McIntyre S, Saloojee G, Hilberink SR, Tatishvili N, Dan B. Towards functional improvement of motor disorders associated with cerebral palsy. Lancet Neurol. 2023 Mar;22(3):229-243. doi: 10.1016/S1474-4422(23)00004-2. Epub 2023 Jan 16.
- Anttila H, Autti-Ramo I, Suoranta J, Makela M, Malmivaara A. Effectiveness of physical therapy interventions for children with cerebral palsy: a systematic review. BMC Pediatr. 2008 Apr 24;8:14. doi: 10.1186/1471-2431-8-14.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10980825GSPT (Other Identifier: Ziauddin University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Cerebral Palsy (CP)
-
Ibadat International University, IslamabadRecruitingCerebral Palsy (CP) | Athetoid CPPakistan
-
IRCCS Fondazione Stella MarisUniversity of Siena, ItalyRecruitingCerebral Palsy (CP) | Motor Imagery | CP (Cerebral Palsy) | Action ObservationItaly
-
Cairo UniversityCompletedCerebral Palsy (CP) | Unilateral Cerebral PalsyEgypt
-
University of California, San FranciscoNot yet recruitingCerebral Palsy | Cerebral Palsy (CP) | Infant | Cerebral Palsy InfantileUnited States
-
Holland Bloorview Kids Rehabilitation HospitalCanadian Institutes of Health Research (CIHR)RecruitingCerebral Palsy (CP) | Hemiplegic Cerebral PalsyCanada
-
International Clinic of Rehabilitation, UkraineElita Rehabilitation CenterRecruitingCerebral Palsy (CP)Ukraine
-
University of ThessalyNot yet recruiting
-
Centre Médico-Chirurgical de Réadaptation des Massues...Recruiting
-
Baylor UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...RecruitingCerebral Palsy (CP)United States
-
Istanbul University - CerrahpasaActive, not recruitingCerebral Palsy (CP)Turkey (Türkiye)
Clinical Trials on Experimental Group
-
Finis Terrae UniversityNot yet recruitingPostoperative Pain | Respiratory ComplicationChile
-
Riphah International UniversityRecruitingAthletic Performance | Muscle StrengthPakistan
-
Suleyman Demirel UniversityRecruitingOsteoporosis (Senile)Turkey (Türkiye)
-
Riphah International UniversityCompletedEffects of Rhythmic Stabilization With and Without Closed Kinetic Chain Exercises Among Fast BowlersSports Physical TherapyPakistan
-
University of AlcalaRecruitingTo be Approved by the Ethics CommitteeSpain
-
Sahmyook UniversityNot yet recruitingStrokeKorea, Republic of
-
Virginia Commonwealth UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedChronic Low Back Pain | Fear of Pain | Fear of InjuryUnited States
-
Riphah International UniversityCompletedSports Physical TherapyPakistan
-
Ataturk UniversityArtvin Coruh UniversityCompleted