Better Understand Motor Deficits Associated With Autism Spectrum Disorders: Development of an Assessment Protocol (MOTRICITE TSA)

This research is a case-control study aiming to characterize motor peculiarities (objective quantitative and qualitative measures) and its psycho-physiological correlates of children with ASD.

Study Overview

Detailed Description

The main objective is to measure jointly and in an automated and standardized manner the performance and motor patterns within the framework of tasks measuring the performance and patterns of general motor skills (postures, walking, coordination overall), fine motor skills (graphics, pointing task) and oculomotricity (visual orientation and control).

The secondary objective is to investigate the relationships between motor difficulties and cognitive and social disorders found in children with ASD.

  • Compare the motor performance data in the 3 major motor domains with each other (overall, fine and oculomotor);
  • Evaluate intergroup differences based on clinical characteristics (ADOS-2, ADI-R, CARS 2 scores), age, IQ, socio-communication profile score (SRS-2) and presence comorbidities (TADH, TDC).

Study Type

Interventional

Enrollment (Estimated)

110

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

Study Contact Backup

Study Locations

      • Bordeaux, France, 33076
        • Recruiting
        • Centre Hospitalier Charles Perrens
        • Contact:
      • La Rochelle, France, 17019
        • Recruiting
        • Centre Hospitalier La Rochelle Re Aunis
        • Contact:
        • Principal Investigator:
          • Helene COTTENCEAU, MD
      • Limoges, France, 87042
        • Recruiting
        • CHU de Limoges
        • Contact:
        • Principal Investigator:
          • Eric LEMONNIER, MD
      • Poitiers, France, 86021
        • Recruiting
        • Centre Hospitalier Henri Laborit
        • Contact:
        • Principal Investigator:
          • Jean XAVIER, MD

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

6 years to 11 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria :

All participants :

  • Be between 6 and 11 years old
  • Mastery of the French language
  • Be affiliated with a Social Security scheme or benefit from affiliation by a third person
  • Both parents (or the holder of legal authority) have read, understood and signed the study consent
  • Be affiliated with social security

Participants with ASD should also verify the following inclusion criteria:

  • Being diagnosed with ASD (DSM-V)

Exclusion Criteria :

All participants :

  • Refusal to participate in the research on the part of the participant and / or holders of parental authority.
  • Be a person benefiting from enhanced protection, namely : persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment.
  • Have uncorrected visual or hearing problems
  • To have concomitant psychotropic drug treatments not stabilized, initiated in the last 2 months: antipsychotics, mood stabilizers, anti-epileptics, psychostimulants, antidepressants.
  • Have a motor handicap of the upper or lower limbs, fitted or not.
  • Have diagnosed neurological or psychiatric disorders, present a general or metabolic pathology having a known impact on the child's motor skills (eg: Epilepsy, Tics and Gilles de la Tourette Syndrome, Intellectual Deficiency, Neuromuscular Syndrome, Metabolic Neurological Syndrome , neoplasms)
  • Suspicion of low intellectual efficiency if at least one of the two subtests (Similarities or Matrices) of WISC V (retrieved from the medical file if the TSA participant) presents a result (standard score) strictly lower than 7.

Participants without ASD :

  • Participant with ADHD (Attention Deficit Disorder with or without Hyperactivity) or CDD (Developmental Coordination Disorder)

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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Epidemiology
Recording of participant's performance during eye, fine motor and gross motor tests Passing self and hetero questionnaires.

Recording of participant's performance during eye, fine motor and gross motor tests; Children's gross motor skills will be assessed through a biomechanical analysis.

Eye movements will be recorded using the eye-tracking system (Tobii Pro TX300). The technique used is the corneal reflection technique.

Passing self and hetero questionnaires.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement performance of fine motor skills (graphics, pointing task)
Time Frame: At 3 month
Jointly and in an automated and standardized manner, measure performance in the context of tasks measuring the performance and patterns of general motor skills (postures, walking, overall coordination), fine motor skills (graphics, pointing task) and oculomotricity (visual orientation and control).
At 3 month
Measurement performance of general motor skills with biomechanical analysis
Time Frame: At 3 month
Jointly and in an automated and standardized manner, measure motor patterns in the context of tasks measuring the performance and patterns of general motor skills (postures, walking, overall coordination), fine motor skills (graphics, pointing task) and oculomotricity (visual orientation and control).
At 3 month
Measurement of oculomotricity with eye-tracking system (visual orientation and control)
Time Frame: At 3 month
Jointly and in an automated and standardized manner, motor patterns in the context of tasks measuring the performance and patterns of general motor skills (postures, walking, overall coordination), fine motor skills (graphics, pointing task) and oculomotricity (visual orientation and control).
At 3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor performance : success, error rate (%)
Time Frame: At visit 1 and visit 2, an average of 3 months
At visit 1 and visit 2, an average of 3 months
Motor performance : task duration (ms), reaction time (ms) and latency (ms)
Time Frame: At visit 1 and visit 2, an average of 3 months
At visit 1 and visit 2, an average of 3 months
IQ as assessed using WISC IV
Time Frame: At visit 1 and visit 2, an average of 3 months
At visit 1 and visit 2, an average of 3 months
Score of socio-communicative skills as assessed using Social Responsiveness Scale
Time Frame: At visit 1 and visit 2, an average of 3 months

Social Responsiveness Scale :

Min = 30, Max=90 Higher scores mean a worse outcome

At visit 1 and visit 2, an average of 3 months
ADHD as assessed using Conners-3
Time Frame: At visit 1 and visit 2, an average of 3 months
At visit 1 and visit 2, an average of 3 months
Developmental Coordination Disorder as assessed using Developmental Coordination Disorder Questionnaire
Time Frame: At visit 1 and visit 2, an average of 3 months

Developmental Coordination Disorder Questionnaire :

Min = 15, Max = 75 Higher scores mean a better outcome

At visit 1 and visit 2, an average of 3 months
ASD Clinical Assessment as assessed using Childhood Autism Rating Scale
Time Frame: At visit 1 and visit 2, an average of 3 months

Childhood Autism Rating Scale :

Min = 0, Max = 100 Higher scores mean a worse outcome

At visit 1 and visit 2, an average of 3 months

Collaborators and Investigators

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

Investigators

  • Study Director: Anouck AMESTOY, MD, Physician

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 (Actual)

February 7, 2022

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

December 15, 2021

First Submitted That Met QC Criteria

February 2, 2022

First Posted (Actual)

February 11, 2022

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

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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