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

Обзор

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.

Подробное описание

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).

Вмешательства

• Поведенческое Testing of general motor skills, fine motor skills and occulomotricity
  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.
• Поведенческое Questionnaires
  Passing self and hetero questionnaires.

Первичные конечные точки

• Measurement performance of fine motor skills (graphics, pointing task) [Срок оценки: At 3 month]
• Measurement performance of general motor skills with biomechanical analysis [Срок оценки: At 3 month]
• Measurement of oculomotricity with eye-tracking system (visual orientation and control) [Срок оценки: At 3 month]

Вторичные конечные точки (7)

• Motor performance : success, error rate (%) [Срок оценки: At visit 1 and visit 2, an average of 3 months]
• Motor performance : task duration (ms), reaction time (ms) and latency (ms) [Срок оценки: At visit 1 and visit 2, an average of 3 months]
• IQ as assessed using WISC IV [Срок оценки: At visit 1 and visit 2, an average of 3 months]
• Score of socio-communicative skills as assessed using Social Responsiveness Scale [Срок оценки: At visit 1 and visit 2, an average of 3 months]
• ADHD as assessed using Conners-3 [Срок оценки: At visit 1 and visit 2, an average of 3 months]
• Developmental Coordination Disorder as assessed using Developmental Coordination Disorder Questionnaire [Срок оценки: At visit 1 and visit 2, an average of 3 months]
• ASD Clinical Assessment as assessed using Childhood Autism Rating Scale [Срок оценки: At visit 1 and visit 2, an average of 3 months]

Критерии участия

Критерии включения

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)

Критерии исключения

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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 4 центра

• Centre Hospitalier Charles Perrens — Bordeaux
• Centre Hospitalier La Rochelle Re Aunis — La Rochelle
• CHU de LIMOGES — Limoges
• Centre Hospitalier Henri Laborit — Poitiers

Публикации

• 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. PMID 30618953
• 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. PMID 28748333
• 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. PMID 26594140
• 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. PMID 32408186
• 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. PMID 24349379

Идентификаторы

NCT: NCT05236803 · 2021-A02426-35

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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