NCT07547644

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Apr 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Apr 2026Aug 2026

First Submitted

Initial submission to the registry

April 16, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 23, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

April 25, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2026

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

April 16, 2026

Last Update Submit

April 16, 2026

Conditions

Keywords

cerebral palsyvirtual realitybalanceGMFM

Outcome Measures

Primary Outcomes (6)

  • Gross Motor Skills

    Gross Motor Skills measured via GMFM-88 (domains D and E)

    Baseline

  • Balance

    Balance measured via Pediatric Balance Scale (PBS)

    Baseline

  • Agility

    Agility using the running speed and agility subset of Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)

    Baseline

  • Agility

    Agility using the running speed and agility subset of Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)

    6 weeks

  • Balance

    Balance measured via Pediatric Balance Scale (PBS)

    6 weeks

  • Gross Motor Skills

    Gross Motor Skills measured via GMFM-88 (domains D and E)

    6 weeks

Secondary Outcomes (2)

  • Level of enjoyment

    6 weeks

  • Level of enjoyment

    Baseline

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

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

Conventional Physical Therapy

PLACEBO COMPARATOR

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

Interventions

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.

Virtual Reality Group
control groupBEHAVIORAL

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.

Conventional Physical Therapy

Eligibility Criteria

Age7 Years - 14 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ● 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.

You may not qualify if:

  • ● 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

Ghulam Sakina Awan, MPhil in Physical Therapy

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study follows a double-blinded randomized controlled trial design to compare the effects of Wii Fit-based virtual reality training with conventional physiotherapy in children with spastic cerebral palsy. The model includes two parallel groups with equal allocation and uses a simple random sampling technique through sealed-envelope randomization. A total of 56 participants aged 7-14 years, diagnosed with spastic diplegic cerebral palsy and classified under GMFCS Levels I-II, will be recruited from rehabilitation centers and hospitals in Karachi. Participants will be randomly assigned to one of two groups: Intervention Group - Wii Fit-based virtual reality training Control Group - Conventional physiotherapy Both groups will receive 18 supervised sessions over 6 weeks, consisting of a warm-up, a 20-minute core intervention, and a cool-down. The intervention group will perform structured Wii Fit games targeting balance, gross motor function, strength, coordination, and agility. Th
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2026

First Posted

April 23, 2026

Study Start

April 25, 2026

Primary Completion (Estimated)

July 15, 2026

Study Completion (Estimated)

August 15, 2026

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share