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

Autism Spectrum Disorder Clinical Trial

— MOTRICITE TSA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05236803
• Other study ID #: 2021-A02426-35
• Status: Recruiting
• Phase: N/A
• Start date: February 7, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: June 2024
• Source: Centre Hospitalier Charles Perrens, Bordeaux
• Contact: Anouck AMESTOY, MD
• Phone: 05 56 56 67 19
• Email: aamestoy[@]ch-perrens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: March 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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)

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Behavioral:
• 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.
• Questionnaires
Passing self and hetero questionnaires.

Locations

Country	Name	City	State
France	Centre Hospitalier Charles Perrens	Bordeaux
France	Centre Hospitalier La Rochelle Re Aunis	La Rochelle
France	CHU de LIMOGES	Limoges
France	Centre Hospitalier Henri Laborit	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Charles Perrens, Bordeaux

Country where clinical trial is conducted

France, 

References & 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/ — View 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 Aut — View 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. — View 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, Avon). 2020 Jun;76:105031 — View 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/journa — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Motor performance : success, error rate (%)		At visit 1 and visit 2, an average of 3 months
Secondary	Motor performance : task duration (ms), reaction time (ms) and latency (ms)		At visit 1 and visit 2, an average of 3 months
Secondary	IQ as assessed using WISC IV		At visit 1 and visit 2, an average of 3 months
Secondary	Score of socio-communicative skills as assessed using Social Responsiveness Scale	Social Responsiveness Scale : Min = 30, Max=90 Higher scores mean a worse outcome	At visit 1 and visit 2, an average of 3 months
Secondary	ADHD as assessed using Conners-3		At visit 1 and visit 2, an average of 3 months
Secondary	Developmental Coordination Disorder as assessed using Developmental Coordination Disorder Questionnaire	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
Secondary	ASD Clinical Assessment as assessed using Childhood Autism Rating Scale	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