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

NCT07816120 | Completed DMC

• 1 other identifier: P.T.REC/012/006638
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Down Syndrome; Vibration Therapy; Virtual Reality

Keywords

down syndrome; children; motor function; balance; muscle strength

Outcome Measures

Primary Outcomes (3)

• Muscle strength

  Muscle strength will be assessed by Hand Held Dynamometer

  3 months

• balance

  Balance will be assessed by Biodex Balance System

  3 months

• motor function

  motor function will be assessed by Gross Motor Function Measure

  3 months

Study Arms (2)

virtual reality group

EXPERIMENTAL

participants will receive Wii-Fit program

Device: virtual reality

whole body vibration group

EXPERIMENTAL

participants will receive whole body vibration

Device: whole body vibration

Interventions

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.

virtual reality group

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

whole body vibration group

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Giza, 11432, Egypt

Location

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Mostafa S. Ali, Phd

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor of pediatric physical therapy

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 11, 2026
• Study Start: February 22, 2026
• Primary Completion: May 10, 2026
• Study Completion: July 12, 2026
• Last Updated: September 11, 2026

Record last verified: 2026-09

Locations

EG (1)