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

Primary Purpose

Autistic Spectrum Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mixed Reality training
motor activities
Sponsored by
Université de Reims Champagne-Ardenne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autistic Spectrum Disorder focused on measuring Autistic spectrum disorder, motor skills, mixed reality training

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    "with mixed reality training" group

    "without mixed reality training" group

    Arm Description

    2 Mixed Reality sessions per week for 8 weeks in addition to motor activities usually performed

    group: only motor activities usually performed

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    March 21, 2022
    Last Updated
    April 26, 2022
    Sponsor
    Université de Reims Champagne-Ardenne
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05302544
    Brief Title
    Impact of Mixed Reality Training on Motor Skills in Children With Autistic Spectrum Disorder
    Acronym
    RAMAu
    Official Title
    Impact of Mixed Reality Training on Motor Skills in Children With Autistic Spectrum Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 15, 2022 (Anticipated)
    Primary Completion Date
    May 15, 2023 (Anticipated)
    Study Completion Date
    May 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Université de Reims Champagne-Ardenne

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autistic Spectrum Disorder
    Keywords
    Autistic spectrum disorder, motor skills, mixed reality training

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    44 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    "with mixed reality training" group
    Arm Type
    Experimental
    Arm Description
    2 Mixed Reality sessions per week for 8 weeks in addition to motor activities usually performed
    Arm Title
    "without mixed reality training" group
    Arm Type
    Active Comparator
    Arm Description
    group: only motor activities usually performed
    Intervention Type
    Other
    Intervention Name(s)
    Mixed Reality training
    Intervention Description
    Mixed Reality training: Mixed Reality game with appearance of virtual balloons in the game area that the subject must find and pierce with finger
    Intervention Type
    Other
    Intervention Name(s)
    motor activities
    Intervention Description
    motor activities usually performed
    Primary Outcome Measure Information:
    Title
    change of walking speed
    Description
    change of walking speed between week 0 and week 8 evaluated in meter by second
    Time Frame
    Week 8

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nicolas HOUEL, MCU-PhD
    Phone
    0326918822
    Ext
    +33
    Email
    nicolas.houel@univ-reims.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Coralie BARBE, MD
    Phone
    0326918822
    Ext
    +33
    Email
    currs@univ-reims.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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