NCT07836517

Brief Summary

This study aims to compare the clinical effects of a sensory-motor integration-based exercise program and a virtual reality-based exercise program on gross motor function, balance, and functional mobility in children with cerebral palsy. Participants will be randomly assigned to one of two groups. Both groups will continue to receive standard conventional physiotherapy. In addition, one group will receive a structured sensory-motor integration-based exercise program, while the other group will receive a Nintendo Wii Sports-based virtual reality exercise program. The intervention period will last 16 weeks, with two sessions per week. Outcomes will be assessed before and after the intervention using standardized clinical measures.

Trial Health

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Monitor

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Oct 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Oct 2026Dec 2026

First Submitted

Initial submission to the registry

September 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 23, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

September 23, 2026

Status Verified

September 1, 2026

Enrollment Period

1 month

First QC Date

September 17, 2026

Last Update Submit

September 17, 2026

Conditions

Keywords

Cerebral PalsySensory-Motor IntegrationVirtual RealityGross Motor FunctionFunctional MobilityPediatric Rehabilitation

Outcome Measures

Primary Outcomes (3)

  • Change in Gross Motor Function Measure Dimensions D and E Score

    Gross motor function will be assessed using the Gross Motor Function Measure, dimensions D and E. The assessment will evaluate standing, walking, running, and jumping-related gross motor abilities in children with cerebral palsy.

    Baseline and week 17

  • Change in Pediatric Balance Scale Score

    Functional balance will be assessed using the Pediatric Balance Scale. Higher scores indicate better functional balance performance.

    Baseline and week 17

  • Change in Timed Up and Go Test Performance

    Functional mobility and dynamic balance will be assessed using the Timed Up and Go Test. The time required to stand up from a chair, walk 3 meters, turn, return, and sit down will be recorded in seconds. Shorter completion time indicates better functional mobility.

    Baseline and week 17

Secondary Outcomes (3)

  • Change in ABILHAND-Kids Score

    Baseline and week 17

  • Change in Hand Grip Strength

    Baseline and week 17

  • Change in Physical Activity Self-Efficacy Scale for Children Score

    Baseline and week 17

Study Arms (2)

Sensory-Motor Integration-Based Exercise Program

EXPERIMENTAL

Participants in this group will receive standard conventional physiotherapy in addition to a structured Sensory-Motor Integration-Based Exercise Program. The program will target postural control, balance, body awareness, motor planning, sensory processing, and functional movement organization through tactile, vestibular, and proprioceptive sensory inputs. The intervention will be delivered for 16 weeks, two sessions per week.

Behavioral: Sensory-Motor Integration-Based Exercise Program

Virtual Reality-Based Exercise Program

ACTIVE COMPARATOR

Participants in this group will receive standard conventional physiotherapy in addition to a Nintendo Wii Sports-based Virtual Reality Exercise Program. The program will provide visual and auditory feedback in a game-based environment and will aim to improve motivation, task-oriented movement repetition, balance, and functional motor performance. The intervention will be delivered for 16 weeks, two sessions per week.

Behavioral: Virtual Reality-Based Exercise Program

Interventions

A Nintendo Wii Sports-based virtual reality exercise program using visual and auditory feedback in a game-based environment to support motivation, task-oriented movement repetition, balance, and functional motor performance. The program will be administered in addition to standard conventional physiotherapy.

Also known as: VRBEP
Virtual Reality-Based Exercise Program

A structured sensory-motor integration-based exercise program targeting postural control, balance, motor planning, sensory processing, body awareness, and functional movement organization through tactile, vestibular, and proprioceptive sensory inputs. The program will be administered in addition to standard conventional physiotherapy.

Also known as: SMIBEP
Sensory-Motor Integration-Based Exercise Program

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosed with cerebral palsy, including diplegic, hemiplegic, or dyskinetic types
  • Gross Motor Function Classification System level I, II, or III
  • Aged between 6 and 12 years
  • Having sufficient cognitive ability to understand and follow simple verbal instructions
  • Voluntary participation in the study with legal guardian consent

You may not qualify if:

  • Gross Motor Function Classification System level IV or V
  • Spasticity level of 2 or higher in target muscle groups according to the Modified Ashworth Scale
  • Botulinum toxin injection within the last 6 months
  • Orthopedic or neurological surgery affecting motor function within the last 6 months
  • History of uncontrolled epilepsy or neurological conditions contraindicating virtual reality applications
  • Severe visual or hearing impairment that may prevent participation in the study
  • Concurrent participation in another rehabilitation program during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Metin Sabancı İlköğretim Okulu

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Elif Develi, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking will be applied because participants and care providers cannot be blinded to the type of exercise-based intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of two parallel groups. Both groups will receive standard conventional physiotherapy. One group will additionally receive a Sensory-Motor Integration-Based Exercise Program, while the other group will additionally receive a Nintendo Wii Sports-based Virtual Reality Exercise Program. Both interventions will be delivered for 16 weeks, two sessions per week.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2026

First Posted

September 23, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

September 23, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to the small sample size, pediatric population, and privacy considerations. De-identified aggregate results may be reported in scientific publications or presentations.

Locations