Autism Spectrum DisorderNCT01987037
Neuropsychomotor Functions in Children With Autism Spectrum Disorder
An observational study of Autism Spectrum Disorder, run by Centre Hospitalier Esquirol at 2 sites in France.
Trial summary
The aim of the study is to describe the feasibility of the passation of the assessment battery of psychomotor functions tests (NP-MOT) in children aged 4 to 11 years with a diagnosis of autism spectrum disorder: number and type of evaluable events, number and type of tests with a deficit compared to the standard… Read more about this study
- Who is it for?
- Ages 4 to 11 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- neuropsychomotor assessment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2013to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 4 to 11 years
- All sexes
- No healthy volunteers
- Child
Study population: children attended in the Centre Hospitalier Esquirol and the CRA (Autism Reference Center) in Limousin, France, for suspiscion of autism
Who may be able to join
- informed consent from the parents or the legal representative
- age 4 to 11
- autism spectrum disorder diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition- text revised
Who cannot join
- bad understanding of the french language
- motor disability from lesion or accidental origin, proved genetic or neurologic disease
- deafness, blindness
- parents with administrative or judiciary protection, and without health insurance
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Centre de Ressources Autisme Limousin
Limoges
- Recruiting
Centre Hospitalier esquirol
Limoges
Aude Paquet, 0033555431010 ext. 3185, audepaquet@gmail.com
About this study
The aim of the study is to describe the feasibility of the passation of the assessment battery of psychomotor functions tests (NP-MOT) in children aged 4 to 11 years with a diagnosis of autism spectrum disorder: number and type of evaluable events, number and type of tests with a deficit compared to the standard results.
Read the detailed description
After informed consent obtention, the children will be submitted to the different tests of the battery to evaluate the psychomotor functions. The results will be compared with other data collected from the routine practise : socio-demographic data, medical and developmental antecedents,psychological tests (KABC II, Rey test, London Tower test, ...), psychomotor evaluation (MABC, evaluation of manual praxis, visual abilities, Frostig test), understanding data (N-EEL test), neuropediatric examination, clinical assessment (ADI-R, CARS).
The use of this battery allows this fine discriminative assessment of the psychomotor functions involved in the movement. Exploring each function will allow to take into account qualitative and quantitative aspects of the movement in every aspects, and this is not applied in the routine care until now. Calibration for each event can explore each function independently of each other, and will provide information to determine any specific developmental characteristics improve care.
- Conditions
- Autism Spectrum Disorder
- Being tested
- neuropsychomotor assessment
- Keywords
- autism spectrum disorder, neuropsychomotor assessment, NP-MOT, motor skills, gross motor
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuropsychomotor assessmentBehavioural
Children with autism spectrum disorders pass a specific battery test (NP-MOT) for a neuropsychomotor assessment. This neuropsychomotor assessment is administered in a half-day maximum. This battery aims to investigate passive muscle tone (shoulders, limbs, and trunk), standing and synkinesia, static and dynamic balance, tonic laterality (extensibility and dangling of hands and feet to identify the tonic dominant side), laterality of use, fine-digit movements, digital tactile gnosis, and body spatial integration (knowing left from right: for oneself and that of others, and with regard to objects).
| Study group | Role | What they receive |
|---|---|---|
| tests evaluation | children with autism spectrum disorder subjected to the NP-MOT tests Receives: Behavioral: neuropsychomotor assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
results to the NP-MOT tests battery
the NP-MOT battery tests include several tests to evaluate 9 motor functions (muscle tone, gross motor, laterality, fine-digit movement, digital tactile gnosis, hand-eye skill, body spatial orientation, pace, auditory attention) with 48 subtests.
We describe:
number and type of evaluable tests, number and type of tests with results with 1 Standard Deviation different from the standard results.
number and type of tests with results with 2 Standard Deviation different from the standard results.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Esquirol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bertrand Olliac, Centre Hospitalier Esquirol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01987037
- Sponsor's protocol ID
- 2013-A00644-41
- Status last verified
- Jul 2015
- First submitted
- 12 Nov 2013
- Last updated
- 3 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lasserre E, Vaivre-Douret L, Abadie V. Psychomotor and cognitive impairments of children with CHARGE syndrome: common and variable features. Child Neuropsychol. 2013 Sep;19(5):449-65. doi: 10.1080/09297049.2012.690372. Epub 2012 Jun 14.
PubMed 23906312
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropsychomotor Functions in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT01987037
- Acronym / sponsor ID
- 2013-A00644-41
- Conditions
- Autism Spectrum Disorder
- Keywords
- autism spectrum disorder, neuropsychomotor assessment, NP-MOT, motor skills, gross motor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Hospitalier EsquirolUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 19 Nov 2013 (estimated)
- 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.
The aim of the study is to describe the feasibility of the passation of the assessment battery of psychomotor functions tests (NP-MOT) in children aged 4 to 11 years with a diagnosis of autism spectrum disorder: number and type of evaluable events, number and type of tests with a deficit compared to the standard results.
Detailed description
After informed consent obtention, the children will be submitted to the different tests of the battery to evaluate the psychomotor functions. The results will be compared with other data collected from the routine practise : socio-demographic data, medical and developmental antecedents,psychological tests (KABC II, Rey test, London Tower test, ...), psychomotor evaluation (MABC, evaluation of manual praxis, visual abilities, Frostig test), understanding data (N-EEL test), neuropediatric examination, clinical assessment (ADI-R, CARS).
The use of this battery allows this fine discriminative assessment of the psychomotor functions involved in the movement. Exploring each function will allow to take into account qualitative and quantitative aspects of the movement in every aspects, and this is not applied in the routine care until now. Calibration for each event can explore each function independently of each other, and will provide information to determine any specific developmental characteristics improve care.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tests evaluation | – | Behavioral: neuropsychomotor assessmentchildren with autism spectrum disorder subjected to the NP-MOT tests |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children attended in the Centre Hospitalier Esquirol and the CRA (Autism Reference Center) in Limousin, France, for suspiscion of autism
Key inclusion criteria (3 listed)
- informed consent from the parents or the legal representative
- age 4 to 11
- autism spectrum disorder diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition- text revised
Key exclusion criteria (4 listed)
- bad understanding of the french language
- motor disability from lesion or accidental origin, proved genetic or neurologic disease
- deafness, blindness
- parents with administrative or judiciary protection, and without health insurance
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 |
|---|---|---|
| neuropsychomotor assessmentChildren with autism spectrum disorders pass a specific battery test (NP-MOT) for a neuropsychomotor assessment. This neuropsychomotor assessment is administered in a half-day maximum. This battery aims to investigate passive muscle tone (shoulders, limbs, and trunk), standing and synkinesia, static and dynamic balance, tonic laterality (extensibility and dangling of hands and feet to identify the tonic dominant side), laterality of use, fine-digit movements, digital tactile gnosis, and body spatial integration (knowing left from right: for oneself and that of others, and with regard to objects). | Behavioural | tests evaluation |
Primary outcome
results to the NP-MOT tests battery
Time frame: one day
the NP-MOT battery tests include several tests to evaluate 9 motor functions (muscle tone, gross motor, laterality, fine-digit movement, digital tactile gnosis, hand-eye skill, body spatial orientation, pace, auditory attention) with 48 subtests. We describe: number and type of evaluable tests, number and type of tests with results with 1 Standard Deviation different from the standard results. number and type of tests with results with 2 Standard Deviation different from the standard results.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2015.
- Background: PubMed 23906312Lasserre E, Vaivre-Douret L, Abadie V. Psychomotor and cognitive impairments of children with CHARGE syndrome: common and variable features. Child Neuropsychol. 2013 Sep;19(5):449-65. doi: 10.1080/09297049.2012.690372. Epub 2012 Jun 14.
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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. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by Centre Hospitalier Esquirol at 2 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 3 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aude Paquet (0033555431010 ext. 3185, audepaquet@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
results to the NP-MOT tests battery (time frame: one day). 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 NCT01987037, which also lists 1 linked publication.
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 3 Aug 2015.