AutismNCT06094335
Effect of Virtual Reality on Balance in Autism
A study testing Virtual reality rehabilitation and Traditional physical therapy in people with Autism, run by Batterjee Medical College at 1 site in Saudi Arabia.
Trial 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 Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Autism
- What is being tested?
- Virtual reality rehabilitation and Traditional physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 10 Mar 2023to 12 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Mild ASD
Who cannot join
- Taking medication affect motor
- Had a head injury, genetic disorder, blindness, fracture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Virtual Reality Rehabilitation Training on Posture Control in Children With Autism Spectrum Disorders
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
Read the 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.
- Conditions
- Autism
- Being tested
- Virtual reality rehabilitation, Traditional physical therapy
- Keywords
- autism spectrum disorder, Biodex, Postural Control, Virtual Reality
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality rehabilitationDevice
Children in this group received Virtual Reality Rehabilitation plus traditional physical therapy
Traditional physical therapyOther
Flexibility exercises, strengthening exercises, endurance exercises, and postural stability exercises
| Study group | Role | What they receive |
|---|---|---|
| Study | Experimental | Virtual reality plus traditional physical therapy Receives: Device: Virtual reality rehabilitation; Other: Traditional physical therapy |
| Control | Active comparator | Traditional physical therapy Receives: Other: Traditional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static Balance
Change of overall postural sway scores using Biodex balance system
Measured: 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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start10 Mar 2023
- Primary completion25 Sep 2023
- Study completion12 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study and control groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Batterjee Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed A. Abdel Ghafar, Batterjee Medical College
- Investigators
- Mohamed A Abdel Ghafar, Ph.D., Principal investigator, Batterjee Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094335
- Sponsor's protocol ID
- VRR
- Status last verified
- Oct 2023
- First submitted
- 14 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Virtual Reality Rehabilitation Training on Posture Control in Children With Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT06094335
- Acronym / sponsor ID
- VRR
- Conditions
- Autism
- Keywords
- autism spectrum disorder, Biodex, Postural Control, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Batterjee Medical CollegeUniversity, hospital or other
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 25 Sep 2023 (actual)
- Study completion
- 12 Oct 2023 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Study and control groups
| Arm | Type | Receives |
|---|---|---|
| Study | Experimental | Device: Virtual reality rehabilitation, Other: Traditional physical therapyVirtual reality plus traditional physical therapy |
| Control | Active comparator | Other: Traditional physical therapyTraditional physical therapy |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Mild ASD
Key exclusion criteria (2 listed)
- Taking medication affect motor
- Had a head injury, genetic disorder, blindness, fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality rehabilitationChildren in this group received Virtual Reality Rehabilitation plus traditional physical therapy | Device | Study |
| Traditional physical therapyFlexibility exercises, strengthening exercises, endurance exercises, and postural stability exercises | Other | Control, Study |
Primary outcome
Static Balance
Time frame: 12 weeks
Change of overall postural sway scores using Biodex balance system
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed A Abdel Ghafar, Ph.D. principal investigator
Batterjee Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality rehabilitation and Traditional physical therapy in people with Autism, run by Batterjee Medical College at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static Balance (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.