Effect of Virtual Reality on Balance in Autism

Sponsor

Batterjee Medical College (Other)

Overall Status

Completed

CT.gov ID

NCT06094335

Collaborator

(none)

Enrollment

Location

Arms

7.1

Actual Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Autism	Device: Virtual reality rehabilitation Other: Traditional physical therapy	N/A

Detailed Description

Autism spectrum disorders are a collection of persistent neurodevelopmental disorders characterized by difficulties in social interactions, communication, and repetitive, stereotyped, and restricting behaviors. Movement problems can occur throughout infancy and are one of the early indications of autism. Furthermore, movement impairments are the most often observed nonverbal deficits in autistic children.

Postural stability is described as the capacity to maintain an upright posture by keeping the body's center of gravity over its base of support with little swaying or maximal steadiness, and it is considered a fundamental skill required for normal motor development.

Virtual Reality has been used in the field of balance rehabilitation and training because of its relatively low cost and enjoyment. Therefore, the purpose of this study was to study the effect of VR on balance in children with ASD.

Study Design

Study Type:

Interventional

Actual Enrollment :

53 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Study and control groupsStudy and control groups

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Influence of Virtual Reality Rehabilitation Training on Posture Control in Children With Autism Spectrum Disorders

Actual Study Start Date :

Mar 10, 2023

Actual Primary Completion Date :

Sep 25, 2023

Actual Study Completion Date :

Oct 12, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study Virtual reality plus traditional physical therapy	Device: Virtual reality rehabilitation Children in this group received Virtual Reality Rehabilitation plus traditional physical therapy Other: Traditional physical therapy Flexibility exercises, strengthening exercises, endurance exercises, and postural stability exercises
Active Comparator: Control Traditional physical therapy	Other: Traditional physical therapy Flexibility exercises, strengthening exercises, endurance exercises, and postural stability exercises

Arm

Intervention/Treatment

Experimental: Study

Virtual reality plus traditional physical therapy

Device: Virtual reality rehabilitation

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

Other: Traditional physical therapy

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

Active Comparator: Control

Traditional physical therapy

Other: Traditional physical therapy

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

Outcome Measures

Primary Outcome Measures

Static Balance [12 weeks]
Change of overall postural sway scores using Biodex balance system
Functional Balance [12 weeks]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Mild ASD

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Autism Center	Jeddah		Saudi Arabia

Sponsors and Collaborators

Batterjee Medical College

Investigators

Principal Investigator: Mohamed A Abdel Ghafar, Ph.D., Batterjee Medical College

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed A. Abdel Ghafar, Professor of physical therapy, Batterjee Medical College

ClinicalTrials.gov Identifier:

NCT06094335

Other Study ID Numbers:

First Posted:

Oct 23, 2023

Last Update Posted:

Oct 23, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mohamed A. Abdel Ghafar, Professor of physical therapy, Batterjee Medical College

autism spectrum disorder

Biodex

Postural Control

Virtual Reality

Additional relevant MeSH terms:

Autistic Disorder

Autism Spectrum Disorder

Study Results

No Results Posted as of Oct 23, 2023