Impact of Mixed Reality Training on Motor Skills in Children With Autistic Spectrum Disorder (RAMAu)

April 26, 2022 updated by: Université de Reims Champagne-Ardenne

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • aged between 8 and 12 years old
  • with autistic spectrum disorder
  • male or female
  • agreeing to participate in the study

Exclusion Criteria:

  • Visually impaired or blind.
  • Traumatism and physical injuries
  • Epilepsy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: "with mixed reality training" group
2 Mixed Reality sessions per week for 8 weeks in addition to motor activities usually performed
Other: Mixed Reality training
Mixed Reality training: Mixed Reality game with appearance of virtual balloons in the game area that the subject must find and pierce with finger
Other: motor activities
motor activities usually performed
Active Comparator: "without mixed reality training" group
group: only motor activities usually performed
Other: motor activities
motor activities usually performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of walking speed
Time Frame: Week 8
change of walking speed between week 0 and week 8 evaluated in meter by second
Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Reims Champagne-Ardenne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 15, 2022

Primary Completion (Anticipated)

May 15, 2023

Study Completion (Anticipated)

May 30, 2023

Study Registration Dates

First Submitted

March 21, 2022

First Submitted That Met QC Criteria

March 21, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

April 27, 2022

Last Update Submitted That Met QC Criteria

April 26, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022_RIPH_001_RAMAu

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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