Clinical trial NCT05236803: Better Understand Motor Deficits Associated With Autism Spectrum Disorders: Development of an Assessment Protocol
Official title: Better Understand Motor Deficits Associated With Autism Spectrum Disorders: Development of an Assessment Protocol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autisme Spectrum Disorders
Motricity
Cognitive disorders
Behaviour
motor skill differences
Lead sponsor: Centre Hospitalier Charles Perrens, Bordeaux
Sponsor class: OTHER_GOV
First posted: 2022-02-11
Enrollment: 110
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Measurement performance of fine motor skills (graphics, pointing task)
timeFrame: At 3 month
measure: Measurement performance of general motor skills with biomechanical analysis
timeFrame: At 3 month
measure: Measurement of oculomotricity with eye-tracking system (visual orientation and control)
timeFrame: At 3 month
Secondary outcomes:
measure: Motor performance : success, error rate (%)
timeFrame: At visit 1 and visit 2, an average of 3 months
measure: Motor performance : task duration (ms), reaction time (ms) and latency (ms)
timeFrame: At visit 1 and visit 2, an average of 3 months
measure: IQ as assessed using WISC IV
timeFrame: At visit 1 and visit 2, an average of 3 months
measure: Score of socio-communicative skills as assessed using Social Responsiveness Scale
timeFrame: At visit 1 and visit 2, an average of 3 months
measure: ADHD as assessed using Conners-3
timeFrame: At visit 1 and visit 2, an average of 3 months
measure: Developmental Coordination Disorder as assessed using Developmental Coordination Disorder Questionnaire
timeFrame: At visit 1 and visit 2, an average of 3 months
measure: ASD Clinical Assessment as assessed using Childhood Autism Rating Scale
timeFrame: At visit 1 and visit 2, an average of 3 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Centre Hospitalier Charles Perrens
city: La Rochelle
country: France
facility: Centre Hospitalier La Rochelle Re Aunis
city: Limoges
country: France
facility: CHU de LIMOGES
city: Poitiers
country: France
facility: Centre Hospitalier Henri Laborit
Study officials:
affiliation: Physician
name: Anouck AMESTOY, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.