NCT05302544

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 15, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

April 27, 2022

Status Verified

April 1, 2022

Enrollment Period

1 year

First QC Date

March 21, 2022

Last Update Submit

April 26, 2022

Conditions

Keywords

Autistic spectrum disordermotor skillsmixed reality training

Outcome Measures

Primary Outcomes (1)

  • change of walking speed

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

    Week 8

Study Arms (2)

"with mixed reality training" group

EXPERIMENTAL

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

Other: Mixed Reality trainingOther: motor activities

"without mixed reality training" group

ACTIVE COMPARATOR

group: only motor activities usually performed

Other: motor activities

Interventions

Mixed Reality training: Mixed Reality game with appearance of virtual balloons in the game area that the subject must find and pierce with finger

"with mixed reality training" group

motor activities usually performed

"with mixed reality training" group"without mixed reality training" group

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Exercise

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Nicolas HOUEL, MCU-PhD

CONTACT

Coralie BARBE, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2022

First Posted

March 31, 2022

Study Start

May 15, 2022

Primary Completion

May 15, 2023

Study Completion

May 30, 2023

Last Updated

April 27, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share