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Status unknownNCT04122820TDysUpdated Oct 18, 2019

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

An interventional study of Diagnostic of specific learning disabilities or of Developmental Coordination Disorder in Specific Developmental Disorders of Speech and Language, Specific Learning Disorder and Dyslexia, Developmental, sponsored by CNGE IRMG Association. Status unknown at 1 site in France. Open to participants aged 8 Years to 12 Years. Per ClinicalTrials.gov, last updated 2019-10-18.

Sponsored by CNGE IRMG Association · Not applicable, Interventional, and Screening

The sponsor has not verified this record recently (last verified Oct 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
1,800
Allocation
Randomized
Ages
8 Years to 12 Years
Sex
All
01

Study summary

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.

Read the detailed 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.
02

Conditions studied

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

Keywords

  • Specific Learning Disorder
  • Developmental Coordination Disorder
  • Specific Developmental Disorders of Speech and Language
  • Dyslexia, Developmental
  • Dyspraxia
03

In context

Language

243 studies on the registry are indexed under Language; 76 are open to participants now.

This study's planned enrollment of 1,800 is above the median of 65 across 158 interventional studies indexed under Language.

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Lead sponsor

CNGE IRMG Association is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
1,800 participants (estimated)

Study arms

  • Other
    Presence of HV-Labile

    Presence of vertical heterophoria labile with proprioceptive Maddox

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

  • Other
    Absence of HV-Labile

    Presence of stable vertical heterophoria or stable orthophoria with proprioceptive Maddox

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

Interventions

  • Diagnostic testDiagnostic 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.

06

What researchers measure

Primary outcomes

  1. Sensitivity of the HV-Labile to SLD or DCD

    Estimated and provided with its 95% confidence interval.

    Time frame: through study completion, an average of 3 year

Secondary outcomes

  1. Specificity of the HV-Labile to SLD or DCD

    Estimated and provided with its 95% confidence interval.

    Time frame: through study completion, an average of 3 year

  2. Positive and negative likelihood ratios

    Estimated and provided with its 95% confidence interval.

    Time frame: through study completion, an average of 3 year

  3. Prevalence of children with HV-Labile

    Estimated and provided with its 95% confidence interval.

    Time frame: through study completion, an average of 3 year

  4. Correlation coefficient between the symptomatic proprioceptive questionnaire and the presence of HV-Labile

    Estimated and provided with its 95% confidence interval.

    Time frame: through study completion, an average of 3 year

  5. Positive predictive values

    Estimated and provided with its 95% confidence interval.

    Time frame: through study completion, an average of 3 year

  6. Negative predictive values

    Estimated and provided with its 95% confidence interval.

    Time frame: through study completion, an average of 3 year

Other outcomes

  1. Calculation of results based on a Cut Off at -1.5 standard deviation, or -2 standard deviation, to determine the presence of a SLD or a DCD

    Estimated and provided with its 95% confidence interval.

    Time frame: through study completion, an average of 3 year

07

Study locations

1 of 1 sites recruiting
  • Office-based general practioner
    Strasbourg, Alsace 67000, France
    Recruiting
08

References and documents

Publications

  • 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. PubMed 26445526 ↗

Individual participant data

Plan to share: No — IPD will not be shared with other researchers.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04122820
Lead sponsor
CNGE IRMG Association
Collaborators
Scalab CNRS 9193
Responsible party
Luc Virlet (Principal Investigator, Scalab CNRS 9193) — Principal investigator
First posted
Oct 10, 2019
Start date
Oct 16, 2019
Primary completion
Oct 30, 2021 (estimated)
Completion
Oct 30, 2022 (estimated)
Last update
Oct 18, 2019

Study contacts

Luc Virlet
Contact
virlet.luc@laposte.net
+33678296310
Joel Cogneau
Contact
j.cogneau@irmg.fr
+33674787920
Luc Virlet
principal investigator · SCalab CNRS 9193, Lille University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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