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

• Sponsor: Université de Reims Champagne-Ardenne (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05302544
• Collaborator: (none)
• Enrollment: 44
• Arms: 2
• Anticipated Duration (Months): 12.5

Study Details

Study Description

Brief 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.). 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.

Condition or Disease	Intervention/Treatment	Phase
Autistic Spectrum Disorder	Other: Mixed Reality training; Other: motor activities	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Impact of Mixed Reality Training on Motor Skills in Children With Autistic Spectrum Disorder
• Anticipated Study Start Date: May 15, 2022
• Anticipated Primary Completion Date: May 15, 2023
• Anticipated Study Completion Date: May 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. change of walking speed [Week 8]

   change of walking speed between week 0 and week 8 evaluated in meter by second

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Université de Reims Champagne-Ardenne

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Université de Reims Champagne-Ardenne
• ClinicalTrials.gov Identifier: NCT05302544
• Other Study ID Numbers: 2022_RIPH_001_RAMAu
• First Posted: Mar 31, 2022
• Last Update Posted: Apr 27, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Université de Reims Champagne-Ardenne: Autistic spectrum disorder; motor skills; mixed reality training
• Additional relevant MeSH terms: Disease; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive

Study Results

No Results Posted as of Apr 27, 2022