NCT07747961

Brief Summary

This randomized controlled trial aimed to evaluate the effectiveness of a Virtual Reality (VR)-mediated gamified rehabilitation program compared with conventional physical therapy in children with spastic diplegic cerebral palsy. Forty-two children aged 7-15 years with Gross Motor Function Classification System (GMFCS) Levels II and III were recruited from Rafsan Neuro Rehab Center, Peshawar. Participants were randomly allocated into two equal groups. The intervention group received VR-based gamified rehabilitation using Xbox Kinect along with physiotherapy, while the control group received conventional physiotherapy only. Both groups completed 18 treatment sessions over six weeks. Outcome measures included the Timed Up and Go Test (TUG), Pediatric Balance Scale (PBS), Trunk Impairment Scale (TIS), and Gross Motor Function Classification System (GMFCS). The findings demonstrated that VR-mediated rehabilitation significantly improved functional mobility, balance, and trunk control compared with conventional therapy. The study concludes that VR-based rehabilitation is an effective, motivating, and clinically useful intervention for children with spastic diplegic cerebral palsy and may improve rehabilitation outcomes and functional independence.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Progress75%
Mar 2026Sep 2026

Study Start

First participant enrolled

March 3, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 5, 2026

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

August 5, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

July 31, 2026

Last Update Submit

July 31, 2026

Conditions

Spastic Diplegic Cerebral Palsy

Keywords

Spastic DiplegiaGamified RehabilitationGross Motor Function

Outcome Measures

Primary Outcomes (3)

  • Timed Up and Go Test (TUG)

    Timed Up and Go Test (TUG)

    At baseline and after 6 weeks

  • Pediatric Balance Scale (PBS)

    Pediatric Balance Scale (PBS)

    baseline and after 6 weeks

  • Trunk Impairment Scale (TIS)

    Trunk Impairment Scale (TIS)

    Baseline and after 6 weeks

Secondary Outcomes (1)

  • Gross Motor Function Classification System (GMFCS)

    Baseline and after 6 weeks

Study Arms (2)

Virtual Reality Mediated Gamified Rehabilitation Program

EXPERIMENTAL

Virtual Reality Mediated Gamified Rehabilitation Program using Xbox Kinect combined with conventional physiotherapy.

Other: Experimental Group

Conventional Physiotherapy Program

ACTIVE COMPARATOR

Conventional Physiotherapy Program

Other: Control

Interventions

Experimental GroupOTHER

Virtual Reality Mediated Gamified Rehabilitation Program using Xbox Kinect combined with conventional physiotherapy.

Virtual Reality Mediated Gamified Rehabilitation Program
ControlOTHER

Conventional Physiotherapy Program

Conventional Physiotherapy Program

Eligibility Criteria

Age7 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosed with spastic diplegic cerebral palsy.
  • Age between 7-15 years.
  • GMFCS Level II or III.
  • Male and female participants.

You may not qualify if:

  • Other neurological disorders.
  • Visual or hearing impairment.
  • Other types of cerebral palsy.
  • Severe cardiac disease.
  • Orthopedic surgery within previous six months.
  • Recent Botulinum toxin injection.
  • Children taking antispastic or antiepileptic medication.
  • Uncooperative participants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ibadat International University

Islamabad, 47000, Pakistan

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Hafsah Arshad

    Ibadat International University, Islamabad

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hafsah Arshad, Phd*

CONTACT

03315165234hafsah.arshad@uipt.iiui.edu.pk

Tazveena IIUI, MS (paeds)

CONTACT

03139367436hafsaharshad@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

July 31, 2026

First Posted

August 5, 2026

Study Start

March 3, 2026

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

August 5, 2026

Record last verified: 2026-06

Locations

PA(1)