NCT06094335

Brief Summary

Children with ASD have poorer postural balance when compared to normal individuals. So, The aim of this study is to assess the effect of Virtual Reality on postural control in Autistic children

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

March 10, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2023

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

October 14, 2023

Last Update Submit

October 20, 2023

Conditions

Autism

Keywords

autism spectrum disorderBiodexPostural ControlVirtual Reality

Outcome Measures

Primary Outcomes (2)

  • Static Balance

    Change of overall postural sway scores using Biodex balance system

    12 weeks

  • Functional Balance

    Change in balance scores was measured using a pediatric balance scale. PBS collect scores for the 14 tasks assessed. The tasks are scored on a five-point scale (0, 1, 2, 3, or 4), with zero denoting an inability to perform the activity without assistance and four denoting the ability to perform the task with complete independence. Scores range from 0 to 56, with higher scores indicating better postural control

    12 weeks

Study Arms (2)

Study

EXPERIMENTAL

Virtual reality plus traditional physical therapy

Device: Virtual reality rehabilitationOther: Traditional physical therapy

Control

ACTIVE COMPARATOR

Traditional physical therapy

Other: Traditional physical therapy

Interventions

Virtual reality rehabilitationDEVICE

Children in this group received Virtual Reality Rehabilitation plus traditional physical therapy

Study
Traditional physical therapyOTHER

Flexibility exercises, strengthening exercises, endurance exercises, and postural stability exercises

ControlStudy

Eligibility Criteria

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

You may qualify if:

  • Mild ASD

You may not qualify if:

  • Taking medication affect motor
  • Had a head injury, genetic disorder, blindness, fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Autism Center

Jeddah, Saudi Arabia

Location

MeSH Terms

Conditions

Autistic DisorderAutism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Mohamed A Abdel Ghafar, Ph.D.

    Batterjee Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Study and control groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of physical therapy

Study Record Dates

First Submitted

October 14, 2023

First Posted

October 23, 2023

Study Start

March 10, 2023

Primary Completion

September 25, 2023

Study Completion

October 12, 2023

Last Updated

October 23, 2023

Record last verified: 2023-10

Locations

SA(1)