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Better Understand Motor Deficits Associated With Autism Spectrum Disorders: Development of an Assessment Protocol (MOTRICITE TSA)

Primary Purpose

Autism Spectrum Disorder

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Testing of general motor skills, fine motor skills and occulomotricity
Questionnaires
Sponsored by
Centre Hospitalier Charles Perrens, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Autism Spectrum Disorder focused on measuring Autisme Spectrum Disorders, Motricity, Cognitive disorders, Behaviour, motor skill differences

Eligibility Criteria

6 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Centre Hospitalier Charles PerrensRecruiting
  • Centre Hospitalier La Rochelle Re AunisRecruiting
  • CHU de LIMOGESRecruiting
  • Centre Hospitalier Henri LaboritRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Epidemiology

Arm Description

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

Outcomes

Primary Outcome Measures

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).
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).
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).

Secondary Outcome Measures

Motor performance : success, error rate (%)
Motor performance : task duration (ms), reaction time (ms) and latency (ms)
IQ as assessed using WISC IV
Score of socio-communicative skills as assessed using Social Responsiveness Scale
Social Responsiveness Scale : Min = 30, Max=90 Higher scores mean a worse outcome
ADHD as assessed using Conners-3
Developmental Coordination Disorder as assessed using Developmental Coordination Disorder Questionnaire
Developmental Coordination Disorder Questionnaire : Min = 15, Max = 75 Higher scores mean a better outcome
ASD Clinical Assessment as assessed using Childhood Autism Rating Scale
Childhood Autism Rating Scale : Min = 0, Max = 100 Higher scores mean a worse outcome

Full Information

First Posted
December 15, 2021
Last Updated
March 29, 2023
Sponsor
Centre Hospitalier Charles Perrens, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT05236803
Brief Title
Better Understand Motor Deficits Associated With Autism Spectrum Disorders: Development of an Assessment Protocol
Acronym
MOTRICITE TSA
Official Title
Better Understand Motor Deficits Associated With Autism Spectrum Disorders: Development of an Assessment Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2022 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Charles Perrens, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Autisme Spectrum Disorders, Motricity, Cognitive disorders, Behaviour, motor skill differences

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Epidemiology
Arm Type
Other
Arm Description
Recording of participant's performance during eye, fine motor and gross motor tests Passing self and hetero questionnaires.
Intervention Type
Behavioral
Intervention Name(s)
Testing of general motor skills, fine motor skills and occulomotricity
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Questionnaires
Intervention Description
Passing self and hetero questionnaires.
Primary Outcome Measure Information:
Title
Measurement performance of fine motor skills (graphics, pointing task)
Description
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).
Time Frame
At 3 month
Title
Measurement performance of general motor skills with biomechanical analysis
Description
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).
Time Frame
At 3 month
Title
Measurement of oculomotricity with eye-tracking system (visual orientation and control)
Description
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).
Time Frame
At 3 month
Secondary Outcome Measure Information:
Title
Motor performance : success, error rate (%)
Time Frame
At visit 1 and visit 2, an average of 3 months
Title
Motor performance : task duration (ms), reaction time (ms) and latency (ms)
Time Frame
At visit 1 and visit 2, an average of 3 months
Title
IQ as assessed using WISC IV
Time Frame
At visit 1 and visit 2, an average of 3 months
Title
Score of socio-communicative skills as assessed using Social Responsiveness Scale
Description
Social Responsiveness Scale : Min = 30, Max=90 Higher scores mean a worse outcome
Time Frame
At visit 1 and visit 2, an average of 3 months
Title
ADHD as assessed using Conners-3
Time Frame
At visit 1 and visit 2, an average of 3 months
Title
Developmental Coordination Disorder as assessed using Developmental Coordination Disorder Questionnaire
Description
Developmental Coordination Disorder Questionnaire : Min = 15, Max = 75 Higher scores mean a better outcome
Time Frame
At visit 1 and visit 2, an average of 3 months
Title
ASD Clinical Assessment as assessed using Childhood Autism Rating Scale
Description
Childhood Autism Rating Scale : Min = 0, Max = 100 Higher scores mean a worse outcome
Time Frame
At visit 1 and visit 2, an average of 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anouck AMESTOY, MD
Phone
05 56 56 67 19
Email
aamestoy@ch-perrens.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Helen SAVARIEAU
Phone
05 56 56 35 56
Email
hsavarieau@ch-perrens.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anouck AMESTOY, MD
Organizational Affiliation
Physician
Official's Role
Study Director
Facility Information:
Facility Name
Centre Hospitalier Charles Perrens
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anouck AMESTOY, MD
Phone
05 56 56 67 19
Email
aamestoy@ch-perrens.fr
Facility Name
Centre Hospitalier La Rochelle Re Aunis
City
La Rochelle
ZIP/Postal Code
17019
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline ALLIX-BEGUEC, Ph.D.
Phone
05 16 49 42 46
Ext
54 246
Email
caroline.allix-beguec@ght-atlantique17.fr
First Name & Middle Initial & Last Name & Degree
Helene COTTENCEAU, MD
Facility Name
CHU de LIMOGES
City
Limoges
ZIP/Postal Code
87042
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascale DURET-BLANC
Phone
05.55.05.89.87
Email
pascale.duret-blanc@chu-limoges.fr
First Name & Middle Initial & Last Name & Degree
Eric LEMONNIER, MD
Facility Name
Centre Hospitalier Henri Laborit
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilie VALIER-BRASIER
Phone
05.49.44.57.59
Email
emilie.valier-brasier@ch-poitiers.fr
First Name & Middle Initial & Last Name & Degree
Jean XAVIER, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30618953
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.
Results Reference
result
PubMed Identifier
28748333
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.
Results Reference
result
PubMed Identifier
26594140
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.
Results Reference
result
PubMed Identifier
32408186
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. doi: 10.1016/j.clinbiomech.2020.105031. Epub 2020 May 7.
Results Reference
result
PubMed Identifier
24349379
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.
Results Reference
result

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

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