Autistic Spectrum DisorderRAMAuNCT05302544
Impact of Mixed Reality Training on Motor Skills in Children With Autistic Spectrum Disorder
A study testing Mixed Reality training and motor activities in people with Autistic Spectrum Disorder, run by Université de Reims Champagne-Ardenne.
Trial summary
People with autistic spectrum disorder frequently present impaired motricity, or at least different motricity from neurotypical subjects (walking; postural balance; fine motor skills; motor control, etc.). Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Autistic Spectrum Disorder
- What is being tested?
- Mixed Reality training and motor activities
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2022to 30 May 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- aged between 8 and 12 years old
- with autistic spectrum disorder
- male or female
- agreeing to participate in the study
Who cannot join
- Visually impaired or blind.
- Traumatism and physical injuries
- Epilepsy
Trial locations and contacts
No sites are listed yet.
About this study
People with autistic spectrum disorder frequently present impaired motricity, or at least different motricity from neurotypical subjects (walking; postural balance; fine motor skills; motor control, etc.). Motor impairment can have impact on the performance and learning of simple tasks (bathing, dressing, writing, using tools, etc.), especially in children and teenagers.
These last years, new therapeutics such as Virtual, Augmented and Mixed Reality technologies have developed. Their therapeutic interest has been identified in various pathologies like phobia. However, their influence on motor skills has been little studied. The first results obtained with disabled adults described a significant increase in walking speed after a 3-month Mixed Reality training.
Read the detailed description
The aim of the study is to assess the impact of Mixed Reality training on motor skills of children with autistic spectrum disorder.
- Conditions
- Autistic Spectrum Disorder
- Being tested
- Mixed Reality training, motor activities
- Keywords
- Autistic spectrum disorder, motor skills, mixed reality training
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed Reality trainingOther
Mixed Reality training: Mixed Reality game with appearance of virtual balloons in the game area that the subject must find and pierce with finger
motor activitiesOther
motor activities usually performed
| Study group | Role | What they receive |
|---|---|---|
| "with mixed reality training" group | Experimental | 2 Mixed Reality sessions per week for 8 weeks in addition to motor activities usually performed Receives: Other: Mixed Reality training; Other: motor activities |
| "without mixed reality training" group | Active comparator | group: only motor activities usually performed Receives: Other: motor activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of walking speed
change of walking speed between week 0 and week 8 evaluated in meter by second
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start15 May 2022 (estimated)
- Primary completion15 May 2023 (estimated)
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autistic Spectrum DisorderStudies 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
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Reims Champagne-Ardenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302544
- Sponsor's protocol ID
- 2022_RIPH_001_RAMAu
- Acronym
- RAMAu
- Status last verified
- Apr 2022
- First submitted
- 21 Mar 2022
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Mixed Reality Training on Motor Skills in Children With Autistic Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05302544
- Acronym / sponsor ID
- RAMAu / 2022_RIPH_001_RAMAu
- Conditions
- Autistic Spectrum Disorder
- Keywords
- Autistic spectrum disorder, motor skills, mixed reality training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Université de Reims Champagne-ArdenneUniversity, hospital or other
- Study start
- 15 May 2022 (estimated)
- Primary completion
- 15 May 2023 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 31 Mar 2022 (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.
People with autistic spectrum disorder frequently present impaired motricity, or at least different motricity from neurotypical subjects (walking; postural balance; fine motor skills; motor control, etc.). Motor impairment can have impact on the performance and learning of simple tasks (bathing, dressing, writing, using tools, etc.), especially in children and teenagers.
These last years, new therapeutics such as Virtual, Augmented and Mixed Reality technologies have developed. Their therapeutic interest has been identified in various pathologies like phobia. However, their influence on motor skills has been little studied. The first results obtained with disabled adults described a significant increase in walking speed after a 3-month Mixed Reality training.
Detailed description
The aim of the study is to assess the impact of Mixed Reality training on motor skills of children with autistic spectrum disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "with mixed reality training" group | Experimental | Other: Mixed Reality training, Other: motor activities2 Mixed Reality sessions per week for 8 weeks in addition to motor activities usually performed |
| "without mixed reality training" group | Active comparator | Other: motor activitiesgroup: only motor activities usually performed |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- aged between 8 and 12 years old
- with autistic spectrum disorder
- male or female
- agreeing to participate in the study
Key exclusion criteria (3 listed)
- Visually impaired or blind.
- Traumatism and physical injuries
- Epilepsy
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 |
|---|---|---|
| Mixed Reality trainingMixed Reality training: Mixed Reality game with appearance of virtual balloons in the game area that the subject must find and pierce with finger | Other | "with mixed reality training" group |
| motor activitiesmotor activities usually performed | Other | "with mixed reality training" group, "without mixed reality training" group |
Primary outcome
change of walking speed
Time frame: Week 8
change of walking speed between week 0 and week 8 evaluated in meter by second
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Mixed Reality training and motor activities in people with Autistic Spectrum Disorder, run by Université de Reims Champagne-Ardenne.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolas HOUEL, MCU-PhD (0326918822 ext. +33, nicolas.houel@univ-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of walking speed (time frame: Week 8). 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 27 Apr 2022.