NCT07401108

Brief Summary

This randomized controlled study compared the effects of Wii Balance Board training versus reactive balance training on balance control and functional abilities in children with spastic hemiplegic cerebral palsy. Sixty children aged 6-10 years (GMFCS levels I-II, mild spasticity) were randomly assigned to either a Wii-based balance training group or a reactive balance training group. Both groups received a conventional physical therapy program three times per week for eight weeks, with an additional 30 minutes of the assigned balance intervention per session. Balance and functional abilities were assessed before and after treatment using the HUMAC Balance System, Pediatric Balance Scale, Functional Reach Test, and Timed Up and Down Stairs test. The study aimed to evaluate and compare the effectiveness of both interventions in improving balance control and functional performance in this population.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Geographic Reach
1 country

1 active site

Status
active not 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 Start

First participant enrolled

May 24, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2026

Completed
Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

9 months

First QC Date

January 5, 2026

Last Update Submit

February 6, 2026

Conditions

Keywords

Virtual RealityHemiplegic Cerebral PalsyWii Balance BoardReactive Balance Training

Outcome Measures

Primary Outcomes (2)

  • Limits of stability scores

    The Humac Balance System will be used for assessment of balance through limits of stability (LOS) scores. Higher scores indicate better dynamic balance control

    From enrollment to the end of treatment at 8 weeks

  • center of pressure scores

    The Humac Balance System will be used for assessment of balance through center of pressure (COP) scores. Lower values indicate better posture control

    From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (2)

  • Functional reach test scores

    From enrollment to the end of treatment at 8 weeks

  • Timed up-and-down-stairs test scores

    From enrollment to the end of treatment at 8 weeks

Study Arms (2)

Virtual reality using Wii Balance Board

EXPERIMENTAL

The Wii Balance Board is a non-immersive virtual reality (VR) rehabilitation tool that has been widely used in physical therapy to assess and train balance and postural control. It is a force-platform-based device equipped with four pressure sensors (anterior-posterior and medial-lateral) that detect changes in body weight distribution and shifts in the center of pressure (CoP). These data are transmitted in real time to the Nintendo Wii console, where body movements are translated into visual feedback displayed on a screen, allowing users to interact with virtual environments and game-based tasks.

Device: Virtual reality

Reactive Balance training

EXPERIMENTAL

Participants will undergo structured reactive balance training that will consist of three sessions per week over an eight-week period. In Reactive balance training we will use different types of perturbations: External perturbations, Internal perturbation and combination of them. Training will last about 30 minutes.

Other: Reactive Balance Training

Interventions

Participants will undergo a structured balance training program utilizing the Wii Balance Board. The program will consist of three training sessions per week over an eight-week period. The first two weeks will focus on guided exercises with manual assistance and verbal instructions, ensuring that the children are comfortable and correctly performing the exercises. As the participants progress, the manual guidance will be gradually reduced, and verbal instructions alone will be provided for the remaining four weeks of training.

Also known as: Wii Balance Board
Virtual reality using Wii Balance Board

In reactive balance training, each session will include 3-4 of the following five core exercises: lean and release, push/pull, reaching with unexpected perturbation, weight shifting on unstable surfaces, and trip/slip simulation. Exercises will be divided into 2-3 blocks, with 6-8 perturbations in each block and short rest periods between blocks (1-2 min), for a total of 30-40 perturbations per session.

Also known as: Perturbation- Based Training
Reactive Balance training

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Hemiplegic children between 6-10 years old.
  • Both genders will be included.
  • Their motor function will be between level I and II according to Gross Motor Function Classification System (GMFCS) .
  • The degree of spasticity for these children will range from grade 1 to 1+ according to the Modified Ashworth Scale .
  • They will be able to follow instructions during evaluation and treatment procedures

You may not qualify if:

  • Cardiovascular or respiratory disorders.
  • Undergone musculoskeletal surgery or botulinum toxin injection in the lower limbs in past six months
  • Musculoskeletal problems or fixed deformities in the spine and/or lower extremities
  • unstable seizures
  • Visual or hearing impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wahet nour elahayah

Al Mansurah, Daqahlyia, 35511, Egypt

Location

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
lecturer

Study Record Dates

First Submitted

January 5, 2026

First Posted

February 10, 2026

Study Start

May 24, 2025

Primary Completion

February 23, 2026

Study Completion

May 15, 2026

Last Updated

February 10, 2026

Record last verified: 2026-02

Locations