NCT01987037

Brief 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 results.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2013

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 12, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 19, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

August 3, 2015

Status Verified

July 1, 2015

Enrollment Period

2.3 years

First QC Date

November 12, 2013

Last Update Submit

July 31, 2015

Conditions

Keywords

autism spectrum disorderneuropsychomotor assessmentNP-MOTmotor skillsgross motor

Outcome Measures

Primary Outcomes (1)

  • 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.

    one day

Study Arms (1)

tests evaluation

children with autism spectrum disorder subjected to the NP-MOT tests

Behavioral: neuropsychomotor assessment

Interventions

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).

tests evaluation

Eligibility Criteria

Age4 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

children attended in the Centre Hospitalier Esquirol and the CRA (Autism Reference Center) in Limousin, France, for suspiscion of autism

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre de Ressources Autisme Limousin

Limoges, France

RECRUITING

Centre Hospitalier esquirol

Limoges, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 23906312BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D Ph.D.

Study Record Dates

First Submitted

November 12, 2013

First Posted

November 19, 2013

Study Start

October 1, 2013

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

August 3, 2015

Record last verified: 2015-07

Locations