- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06094335
Effect of Virtual Reality on Balance in Autism
Influence of Virtual Reality Rehabilitation Training on Posture Control in Children With Autism Spectrum Disorders
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Jeddah, Saudi Arabia
- Local Autism Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Mild ASD
Exclusion Criteria:
- Taking medication affect motor
- Had a head injury, genetic disorder, blindness, fracture
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study
Virtual reality plus traditional physical therapy
|
Children in this group received Virtual Reality Rehabilitation plus traditional physical therapy
Flexibility exercises, strengthening exercises, endurance exercises, and postural stability exercises
|
Active Comparator: Control
Traditional physical therapy
|
Flexibility exercises, strengthening exercises, endurance exercises, and postural stability exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Static Balance
Time Frame: 12 weeks
|
Change of overall postural sway scores using Biodex balance system
|
12 weeks
|
Functional Balance
Time Frame: 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
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mohamed A Abdel Ghafar, Ph.D., Batterjee Medical College
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VRR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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