NCT05236803

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

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

Study Progress83%
Feb 2022Mar 2027

First Submitted

Initial submission to the registry

December 15, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

February 7, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2022

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

4.7 years

First QC Date

December 15, 2021

Last Update Submit

March 13, 2026

Conditions

Keywords

Autisme Spectrum DisordersMotricityCognitive disordersBehaviourmotor skill differences

Outcome Measures

Primary Outcomes (3)

  • Measurement performance of fine motor skills (graphics, pointing task)

    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

    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)

    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 Outcomes (7)

  • Motor performance : success, error rate (%)

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

  • Motor performance : task duration (ms), reaction time (ms) and latency (ms)

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

  • IQ as assessed using WISC IV

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

  • Score of socio-communicative skills as assessed using Social Responsiveness Scale

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

  • ADHD as assessed using Conners-3

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

  • +2 more secondary outcomes

Study Arms (1)

Epidemiology

OTHER

Recording of participant's performance during eye, fine motor and gross motor tests Passing self and hetero questionnaires.

Behavioral: Testing of general motor skills, fine motor skills and occulomotricityBehavioral: Questionnaires

Interventions

QuestionnairesBEHAVIORAL

Passing self and hetero questionnaires.

Epidemiology

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.

Epidemiology

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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
  • Being diagnosed with ASD (DSM-V)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Centre Hospitalier Charles Perrens

Bordeaux, 33076, France

RECRUITING

Centre Hospitalier La Rochelle Re Aunis

La Rochelle, 17019, France

RECRUITING

CHU de LIMOGES

Limoges, 87042, France

RECRUITING

Centre Hospitalier Henri Laborit

Poitiers, 86021, France

RECRUITING

Related Publications (5)

  • Biffi E, Costantini C, Ceccarelli SB, Cesareo A, Marzocchi GM, Nobile M, Molteni M, Crippa A. Gait Pattern and Motor Performance During Discrete Gait Perturbation in Children With Autism Spectrum Disorders. Front Psychol. 2018 Dec 11;9:2530. doi: 10.3389/fpsyg.2018.02530. eCollection 2018.

  • Cazalets JR, Bestaven E, Doat E, Baudier MP, Gallot C, Amestoy A, Bouvard M, Guillaud E, Guillain I, Grech E, Van-Gils J, Fergelot P, Fraisse S, Taupiac E, Arveiler B, Lacombe D. Evaluation of Motor Skills in Children with Rubinstein-Taybi Syndrome. J Autism Dev Disord. 2017 Nov;47(11):3321-3332. doi: 10.1007/s10803-017-3259-1.

  • D'Mello AM, Stoodley CJ. Cerebro-cerebellar circuits in autism spectrum disorder. Front Neurosci. 2015 Nov 5;9:408. doi: 10.3389/fnins.2015.00408. eCollection 2015.

  • Eggleston JD, Harry JR, Cereceres PA, Olivas AN, Chavez EA, Boyle JB, Dufek JS. Lesser magnitudes of lower extremity variability during terminal swing characterizes walking patterns in children with autism. Clin Biomech (Bristol). 2020 Jun;76:105031. doi: 10.1016/j.clinbiomech.2020.105031. Epub 2020 May 7.

  • Hak L, Houdijk H, Beek PJ, van Dieen JH. Steps to take to enhance gait stability: the effect of stride frequency, stride length, and walking speed on local dynamic stability and margins of stability. PLoS One. 2013 Dec 13;8(12):e82842. doi: 10.1371/journal.pone.0082842. eCollection 2013.

MeSH Terms

Conditions

Autism Spectrum DisorderCognitive DysfunctionBehavior

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersCognition DisordersNeurocognitive Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Anouck AMESTOY, MD

    Physician

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2021

First Posted

February 11, 2022

Study Start

February 7, 2022

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations