Ambulatory Screening for Specific Learning Disabilities (SLD) and Developmental Coordination Disorder (DCD).

NCT ID: NCT04122820

Last Updated: 2019-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-16

Study Completion Date

2022-10-30

Brief Summary

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To evaluate, in primary care, the sensitivity of Heterophory-Vertical-Labile (HV-Labile) in ambulatory screening for Specific Learning Disabilities (SLD) and Developmental Coordination Disorder (DCD). in children aged 8 to 12 years.

Detailed Description

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General practitioners during a day of professional training on learning disabilities will be trained to perform the proprioceptive Maddox, to search for a HVLabile.

Each trained practitioner will then test at least six children aged 8 to 12 years old in his or her practice, seen at random

250 to 300 physicians will be trained as part of this research

EXPERIMENTAL DESIGN

* Cross-sectional study with prospective recruitment.
* Search for a Vertical Labile Heterophory (HV-Labile).
* Prescription of a standardized speech and language screening assessment for HV-Labile, and in the same number of children without HV-Labile by secondary coupling.
* Delivery of symptomatic questionnaire.
* In case of learning disabilities, the attending physician should look for a possible etiology.
* Adapted speech therapy care for more than six months.
* Speech and language therapy check-up at more than six months.

Conditions

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Specific Developmental Disorders of Speech and Language Specific Learning Disorder Dyslexia, Developmental Developmental Coordination Disorder Dyspraxia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Comparison of the presence of a specific learning disability, or a Developmental Coordination Disorder, in the case of the presence or absence of referential instability of central origin.
Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors
An adjudication committee to determine the presence or absence of a specific learning disability will be set up, regardless of the presence of a central reference instability.

Study Groups

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Presence of HV-Labile

Presence of vertical heterophoria labile with proprioceptive Maddox

Group Type OTHER

Diagnostic of specific learning disabilities or of Developmental Coordination Disorder

Intervention Type DIAGNOSTIC_TEST

Speech therapy assessment, or occupational therapy. In case of pathological disorder, search for a sensory disorder, and therapeutic management. If the pathological disorder persists for more than six months, elimination of a secondary etiology.

Absence of HV-Labile

Presence of stable vertical heterophoria or stable orthophoria with proprioceptive Maddox

Group Type OTHER

Diagnostic of specific learning disabilities or of Developmental Coordination Disorder

Intervention Type DIAGNOSTIC_TEST

Speech therapy assessment, or occupational therapy. In case of pathological disorder, search for a sensory disorder, and therapeutic management. If the pathological disorder persists for more than six months, elimination of a secondary etiology.

Interventions

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Diagnostic of specific learning disabilities or of Developmental Coordination Disorder

Speech therapy assessment, or occupational therapy. In case of pathological disorder, search for a sensory disorder, and therapeutic management. If the pathological disorder persists for more than six months, elimination of a secondary etiology.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

The population studied is composed of children:

* from 8 to 12 years old
* seen for any reason for consultation in general practice
* Schooled in an ordinary environment since the Preparatory Course in France
* Francophone parents
* One of whose parents has signed the consent
* Consent of the child
* Social Insured

Exclusion Criteria

The background and living conditions that may promote secondary learning disabilities, for example:

* Child with a known intellectual disability (Wisc)
* Child in IME (Institut Médico Educatif)
* Child followed in SESSAD (Specialised education service at home)
* Child not knowing how to answer the questions asked
* Child with a known etiology causing learning disabilities (epilepsy, autism spectrum disorder, hearing impairment, visual impairment (deafness, blindness, low vision))
* Child on treatment (antiepileptic, neuroleptic, antidepressant, anxiolytic)
* Child under the care of a psychiatrist,
* Child followed by the CMP (Centre médico-psychologique)
* Child living in an institution,
* Adopted child
* A child whose mother has experienced known depression during the child's early childhood (0-18 months) because it causes attachment disorders, which can impact the child's development, including learning
* Child of a family that has lived through more than two family recompositions
* Child known to be a victim of abuse.
* Out of school child.

To determine the presence of an HV-Labile

* Child with a known visual correction greater than + or- 2 diopters
* Known amblyopic child
* Known strabic child
* Child with no known binocular vision.
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Scalab CNRS 9193

OTHER

Sponsor Role collaborator

CNGE IRMG Association

OTHER

Sponsor Role lead

Responsible Party

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Luc Virlet

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luc Virlet

Role: PRINCIPAL_INVESTIGATOR

SCalab CNRS 9193, Lille University

Locations

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Office-based general practioner

Strasbourg, Alsace, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Luc Virlet

Role: CONTACT

+33678296310

Joel Cogneau

Role: CONTACT

+33674787920

Facility Contacts

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Luc Virlet

Role: primary

+33678296310

References

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Quercia P, Quercia M, Feiss LJ, Allaert F. The distinctive vertical heterophoria of dyslexics. Clin Ophthalmol. 2015 Sep 25;9:1785-97. doi: 10.2147/OPTH.S88497. eCollection 2015.

Reference Type RESULT
PMID: 26445526 (View on PubMed)

Related Links

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http://www.softal.fr/IMG/pdf/softa-poster-7_avril_14_-virlet-.pdf

The study undertaken with 100 all-view children shows a strong correlation between the presence of SDP-HV-labile and the presence of specific learning disorders. She encourages us not to neglect the proprioceptive approach in the study of the SLD.

Other Identifiers

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2019-A00416-51

Identifier Type: REGISTRY

Identifier Source: secondary_id

CNGEIRMG 0310

Identifier Type: -

Identifier Source: org_study_id

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