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NCT Number: NCT05236803

Better Understand Motor Deficits Associated With Autism Spectrum Disorders: Development of an Assessment Protocol

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.

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Key information

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Charles Perrens, Bordeaux, France

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Testing of general motor skills, fine motor skills and occulomotricity

Behavioral

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.

Questionnaires

Behavioral

Passing self and hetero questionnaires.

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

Secondary outcomes

  1. Motor performance : success, error rate (%)

    Time frame: At visit 1 and visit 2, an average of 3 months

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

    Time frame: At visit 1 and visit 2, an average of 3 months

  3. IQ as assessed using WISC IV

    Time frame: At visit 1 and visit 2, an average of 3 months

  4. 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

  5. ADHD as assessed using Conners-3

    Time frame: At visit 1 and visit 2, an average of 3 months

  6. 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

  7. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Anouck AMESTOY, MD

CONTACT

[email protected]

05 56 56 67 19

Helen SAVARIEAU

CONTACT

[email protected]

05 56 56 35 56

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Charles Perrens, Bordeaux

Other Gov

Registry information

Acronym: MOTRICITE TSA

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Feb 11, 2022
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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