- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05236803
Better Understand Motor Deficits Associated With Autism Spectrum Disorders: Development of an Assessment Protocol (MOTRICITE TSA)
Study Overview
Status
Conditions
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).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Helen SAVARIEAU
- Phone Number: 05 56 56 35 56
- Email: hsavarieau@ch-perrens.fr
Study Contact Backup
- Name: Anouck AMESTOY, MD
- Phone Number: 05 56 56 67 19
- Email: aamestoy@ch-perrens.fr
Study Locations
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-
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Bordeaux, France, 33076
- Recruiting
- Centre Hospitalier Charles Perrens
-
Contact:
- Anouck AMESTOY, MD
- Phone Number: 05 56 56 67 19
- Email: aamestoy@ch-perrens.fr
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La Rochelle, France, 17019
- Recruiting
- Centre Hospitalier La Rochelle Re Aunis
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Contact:
- Caroline ALLIX-BEGUEC, Ph.D.
- Phone Number: 54 246 05 16 49 42 46
- Email: caroline.allix-beguec@ght-atlantique17.fr
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Principal Investigator:
- Helene COTTENCEAU, MD
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Limoges, France, 87042
- Recruiting
- CHU de Limoges
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Contact:
- Pascale DURET-BLANC
- Phone Number: 05.55.05.89.87
- Email: pascale.duret-blanc@chu-limoges.fr
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Principal Investigator:
- Eric LEMONNIER, MD
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Poitiers, France, 86021
- Recruiting
- Centre Hospitalier Henri Laborit
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Contact:
- Emilie VALIER-BRASIER
- Phone Number: 05.49.44.57.59
- Email: emilie.valier-brasier@ch-poitiers.fr
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Principal Investigator:
- Jean XAVIER, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Epidemiology
Recording of participant's performance during eye, fine motor and gross motor tests Passing self and hetero questionnaires.
|
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.
Passing self and hetero questionnaires.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
At 3 month
|
|
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).
|
At 3 month
|
|
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).
|
At 3 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Motor performance : success, error rate (%)
Time Frame: At visit 1 and visit 2, an average of 3 months
|
At visit 1 and visit 2, an average of 3 months
|
|
|
Motor performance : task duration (ms), reaction time (ms) and latency (ms)
Time Frame: At visit 1 and visit 2, an average of 3 months
|
At visit 1 and visit 2, an average of 3 months
|
|
|
IQ as assessed using WISC IV
Time Frame: At visit 1 and visit 2, an average of 3 months
|
At visit 1 and visit 2, an average of 3 months
|
|
|
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 |
At visit 1 and visit 2, an average of 3 months
|
|
ADHD as assessed using Conners-3
Time Frame: At visit 1 and visit 2, an average of 3 months
|
At visit 1 and visit 2, an average of 3 months
|
|
|
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 |
At visit 1 and visit 2, an average of 3 months
|
|
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 |
At visit 1 and visit 2, an average of 3 months
|
Collaborators and Investigators
Investigators
- Study Director: Anouck AMESTOY, MD, Physician
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Neurocognitive Disorders
- Cognition Disorders
- Neurodevelopmental Disorders
- Child Development Disorders, Pervasive
- Autism Spectrum Disorder
- Cognitive Dysfunction
- Behavior
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Surveys and Questionnaires
Other Study ID Numbers
- 2021-A02426-35
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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