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

C

CNGE IRMG Association

Status

Unknown

Conditions

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

Treatments

Diagnostic Test: Diagnostic of specific learning disabilities or of Developmental Coordination Disorder

Study type

Interventional

Funder types

Other

Identifiers

NCT04122820
CNGEIRMG 0310
2019-A00416-51 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

1,800 estimated patients

Sex

All

Ages

8 to 12 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

1,800 participants in 2 patient groups

Presence of HV-Labile
Other group
Description:
Presence of vertical heterophoria labile with proprioceptive Maddox
Treatment:
Diagnostic Test: Diagnostic of specific learning disabilities or of Developmental Coordination Disorder
Absence of HV-Labile
Other group
Description:
Presence of stable vertical heterophoria or stable orthophoria with proprioceptive Maddox
Treatment:
Diagnostic Test: Diagnostic of specific learning disabilities or of Developmental Coordination Disorder

Trial contacts and locations

1

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Central trial contact

Luc Virlet; Joel Cogneau

Data sourced from clinicaltrials.gov

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