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

Sensitivity of the Search for a Heterophory-Vertical-Labile (HV-Labile) for Ambulatory Screening for Specific Learning Disabilities (SLD) or Developmental Coordination Disorder (DCD).

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04122820
Acronym
TDys
Enrollment
1800
Registered
2019-10-10
Start date
2019-10-16
Completion date
2022-10-30
Last updated
2019-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

Brief 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.

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.

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.

Sponsors

Scalab CNRS 9193
CollaboratorOTHER
CNGE IRMG Association
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity of the HV-Labile to SLD or DCDthrough study completion, an average of 3 yearEstimated and provided with its 95% confidence interval.

Secondary

MeasureTime frameDescription
Specificity of the HV-Labile to SLD or DCDthrough study completion, an average of 3 yearEstimated and provided with its 95% confidence interval.
Positive and negative likelihood ratiosthrough study completion, an average of 3 yearEstimated and provided with its 95% confidence interval.
Prevalence of children with HV-Labilethrough study completion, an average of 3 yearEstimated and provided with its 95% confidence interval.
Positive predictive valuesthrough study completion, an average of 3 yearEstimated and provided with its 95% confidence interval.
Negative predictive valuesthrough study completion, an average of 3 yearEstimated and provided with its 95% confidence interval.
Correlation coefficient between the symptomatic proprioceptive questionnaire and the presence of HV-Labilethrough study completion, an average of 3 yearEstimated and provided with its 95% confidence interval.

Other

MeasureTime frameDescription
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 DCDthrough study completion, an average of 3 yearEstimated and provided with its 95% confidence interval.

Countries

France

Contacts

Primary ContactLuc Virlet
virlet.luc@laposte.net+33678296310
Backup ContactJoel Cogneau
j.cogneau@irmg.fr+33674787920

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026