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Effect of Virtual Reality on Balance in Autism

Primary Purpose

Autism

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Virtual reality rehabilitation
Traditional physical therapy
Sponsored by
Batterjee Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism focused on measuring autism spectrum disorder, Biodex, Postural Control, Virtual Reality

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Mild ASD Exclusion Criteria: Taking medication affect motor Had a head injury, genetic disorder, blindness, fracture

Sites / Locations

  • Local Autism Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study

Control

Arm Description

Virtual reality plus traditional physical therapy

Traditional physical therapy

Outcomes

Primary Outcome Measures

Static Balance
Change of overall postural sway scores using Biodex balance system
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

Secondary Outcome Measures

Full Information

First Posted
October 14, 2023
Last Updated
October 20, 2023
Sponsor
Batterjee Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT06094335
Brief Title
Effect of Virtual Reality on Balance in Autism
Official Title
Influence of Virtual Reality Rehabilitation Training on Posture Control in Children With Autism Spectrum Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 10, 2023 (Actual)
Primary Completion Date
September 25, 2023 (Actual)
Study Completion Date
October 12, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Batterjee Medical College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism
Keywords
autism spectrum disorder, Biodex, Postural Control, Virtual Reality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Study and control groups
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study
Arm Type
Experimental
Arm Description
Virtual reality plus traditional physical therapy
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Traditional physical therapy
Intervention Type
Device
Intervention Name(s)
Virtual reality rehabilitation
Intervention Description
Children in this group received Virtual Reality Rehabilitation plus traditional physical therapy
Intervention Type
Other
Intervention Name(s)
Traditional physical therapy
Intervention Description
Flexibility exercises, strengthening exercises, endurance exercises, and postural stability exercises
Primary Outcome Measure Information:
Title
Static Balance
Description
Change of overall postural sway scores using Biodex balance system
Time Frame
12 weeks
Title
Functional Balance
Description
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
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Mild ASD Exclusion Criteria: Taking medication affect motor Had a head injury, genetic disorder, blindness, fracture
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed A Abdel Ghafar, Ph.D.
Organizational Affiliation
Batterjee Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Local Autism Center
City
Jeddah
Country
Saudi Arabia

12. IPD Sharing Statement

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Effect of Virtual Reality on Balance in Autism

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