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Completed

NCT Number: NCT07816120

Comparative Study of Two Applications on Muscle Strength, Balance and Motor Function in Children With Down Syndrome.

To differentiate between the efficacy of virtual reality and whole-body vibration on muscle strength, balance and motor function in children with down syndrome.

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Key information

Conditions

Down Syndrome Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Vibration Therapy Virtual Reality

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo university

Giza, 11432, Egypt

About this study

Is there difference between the efficacy of virtual reality and whole-body vibration on muscle strength, balance and motor function in children with down syndrome?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The age of children ranged from 6 to 10 years old.
  • Children who are able to stand independently.
  • Their heights around one meter or more to meet the assessment criteria of the Biodex balance system.
  • They are able to follow the verbal commands or instructions.

Exclusion criteria

  • Children with deafness and auditory perceptual disorders.
  • Spinal deformities and foot deformities that interfere with balance.
  • Epilepsy or seizures.
  • History of surgical interference in lower limbs.
  • Botulinum toxin injections of the lower limb prior to the study.

Treatment and study plan

Virtual reality

Device

Participants in Group A underwent therapy using the Wii-Fit program, engaging in 30-minute sessions, three times weekly, for three consecutive months. The Nintendo Wii Fit setup comprises a balance board integrated with a force plate and four pressure sensors, which evaluate the center of pressure (COP) and the distribution of load across the board. The intervention included three sequential exercise sets.

Whole Body Vibration

Device

participated in whole-body vibration (WBV) exercises using the KY-3001 fitness machine. Sessions were conducted three times per week over a period of three months, with each session lasting 30 minutes. Each session began with a 5-10-minute warm-up, which included three minutes of walking followed by stretches targeting the hamstrings, quadriceps, and calves

Primary outcomes

  1. Muscle strength

    Time frame: 3 months

    Muscle strength will be assessed by Hand Held Dynamometer

  2. balance

    Time frame: 3 months

    Balance will be assessed by Biodex Balance System

  3. motor function

    Time frame: 3 months

    motor function will be assessed by Gross Motor Function Measure

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 11, 2026
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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