Autism Spectrum DisorderMOTRICITE TSANCT05236803
Better Understand Motor Deficits Associated With Autism Spectrum Disorders: Development of an Assessment Protocol
A study testing Testing of general motor skills, fine motor skills and occulomotricity and Questionnaires in people with Autism Spectrum Disorder, run by Centre Hospitalier Charles Perrens, Bordeaux at 4 sites in France.
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. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Testing of general motor skills, fine motor skills and occulomotricity and Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 4 sitesFrance
- Study dates
- 7 Feb 2022to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
Centre Hospitalier Charles Perrens
Bordeaux, 33076
Anouck AMESTOY, MD, 05 56 56 67 19, aamestoy@ch-perrens.fr
- Recruiting
Centre Hospitalier La Rochelle Re Aunis
La Rochelle, 17019
Caroline ALLIX-BEGUEC, Ph.D., 05 16 49 42 46 ext. 54 246, caroline.allix-beguec@ght-atlantique17.fr
Helene COTTENCEAU, MD
- Recruiting
CHU de LIMOGES
Limoges, 87042
Pascale DURET-BLANC, 05.55.05.89.87, pascale.duret-blanc@chu-limoges.fr
Eric LEMONNIER, MD
- Recruiting
Centre Hospitalier Henri Laborit
Poitiers, 86021
Emilie VALIER-BRASIER, 05.49.44.57.59, emilie.valier-brasier@ch-poitiers.fr
Jean XAVIER, MD
About this study
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.
Read the 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).
- Conditions
- Autism Spectrum Disorder
- Being tested
- Testing of general motor skills, fine motor skills and occulomotricity, Questionnaires
- Keywords
- Autisme Spectrum Disorders, Motricity, Cognitive disorders, Behaviour, motor skill differences
- Medical subject headings
- Autism Spectrum Disorder, Cognitive Dysfunction, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testing of general motor skills, fine motor skills and occulomotricityBehavioural
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.
QuestionnairesBehavioural
Passing self and hetero questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Epidemiology | Other | Recording of participant's performance during eye, fine motor and gross motor tests Passing self and hetero questionnaires. Receives: Behavioral: Testing of general motor skills, fine motor skills and occulomotricity; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At 3 month
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).
Measured: At 3 month
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).
Measured: At 3 month
Secondary outcomes (7)
Motor performance : success, error rate (%)
Measured: At visit 1 and visit 2, an average of 3 months
Motor performance : task duration (ms), reaction time (ms) and latency (ms)
Measured: At visit 1 and visit 2, an average of 3 months
IQ as assessed using WISC IV
Measured: At visit 1 and visit 2, an average of 3 months
Score of socio-communicative skills as assessed using Social Responsiveness Scale
Social Responsiveness Scale :
Min = 30, Max=90 Higher scores mean a worse outcome
Measured: At visit 1 and visit 2, an average of 3 months
ADHD as assessed using Conners-3
Measured: At visit 1 and visit 2, an average of 3 months
Developmental Coordination Disorder as assessed using Developmental Coordination Disorder Questionnaire
Developmental Coordination Disorder Questionnaire :
Min = 15, Max = 75 Higher scores mean a better outcome
Measured: At visit 1 and visit 2, an average of 3 months
ASD Clinical Assessment as assessed using Childhood Autism Rating Scale
Childhood Autism Rating Scale :
Min = 0, Max = 100 Higher scores mean a worse outcome
Measured: At visit 1 and visit 2, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start7 Feb 2022
- Primary completion30 Oct 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Charles Perrens, Bordeaux
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Anouck AMESTOY, MD, Study director, Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05236803
- Sponsor's protocol ID
- 2021-A02426-35
- Acronym
- MOTRICITE TSA
- Status last verified
- Mar 2026
- First submitted
- 15 Dec 2021
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30618953Cazalets 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.
PubMed 28748333D'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.
PubMed 26594140Eggleston 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.
PubMed 32408186Hak 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.
PubMed 24349379
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better Understand Motor Deficits Associated With Autism Spectrum Disorders: Development of an Assessment Protocol
- ClinicalTrials.gov ID
- NCT05236803
- Acronym / sponsor ID
- MOTRICITE TSA / 2021-A02426-35
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autisme Spectrum Disorders, Motricity, Cognitive disorders, Behaviour, motor skill differences
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Centre Hospitalier Charles Perrens, BordeauxOther government
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epidemiology | Other | Behavioral: Testing of general motor skills, fine motor skills and occulomotricity, Behavioral: QuestionnairesRecording of participant's performance during eye, fine motor and gross motor tests Passing self and hetero questionnaires. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testing of general motor skills, fine motor skills and occulomotricityRecording 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. | Behavioural | Epidemiology |
| QuestionnairesPassing self and hetero questionnaires. | Behavioural | Epidemiology |
Primary outcome
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).
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).
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).
7 secondary outcomes
Motor performance : success, error rate (%)
Time frame: 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
IQ as assessed using WISC IV
Time frame: 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
ADHD as assessed using Conners-3
Time frame: 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
ASD Clinical Assessment as assessed using Childhood Autism Rating Scale
Time frame: At visit 1 and visit 2, an average of 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Results publication: PubMed 30618953Biffi 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 publication: PubMed 28748333Cazalets 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 publication: PubMed 26594140D'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 publication: PubMed 32408186Eggleston 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.
- Results publication: PubMed 24349379Hak 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anouck AMESTOY, MD study director
Physician
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Testing of general motor skills, fine motor skills and occulomotricity and Questionnaires in people with Autism Spectrum Disorder, run by Centre Hospitalier Charles Perrens, Bordeaux at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anouck AMESTOY, MD (05 56 56 67 19, aamestoy@ch-perrens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement performance of fine motor skills (graphics, pointing task) (time frame: At 3 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05236803, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.