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

Developmental Coordination Disorder Clinical Trial

— TDys  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04122820
• Other study ID #: CNGEIRMG 0310
• Secondary ID: 2019-A00416-51
• Status: Recruiting
• Phase: N/A
• Start date: October 16, 2019
• Est. completion date: October 30, 2022

Study information

• Verified date: October 2019
• Source: CNGE IRMG Association
• Contact: Luc Virlet
• Phone: +33678296310
• Email: virlet.luc[@]laposte.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1800
• Est. completion date: October 30, 2022
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apraxias
• Developmental Coordination Disorder
• Developmental Disabilities
• Disease
• Dyslexia
• Dyslexia, Developmental
• Dyspraxia
• Learning Disorders
• Motor Skills Disorders
• Specific Developmental Disorders of Speech and Language
• Specific Learning Disorder
• Speech Disorders

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
France	Office-based general practioner	Strasbourg	Alsace

Sponsors (2)

Lead Sponsor	Collaborator
CNGE IRMG Association	Scalab CNRS 9193

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	through study completion, an average of 3 year
Primary	Sensitivity of the HV-Labile to SLD or DCD	Estimated and provided with its 95% confidence interval.	through study completion, an average of 3 year
Secondary	Specificity of the HV-Labile to SLD or DCD	Estimated and provided with its 95% confidence interval.	through study completion, an average of 3 year
Secondary	Positive and negative likelihood ratios	Estimated and provided with its 95% confidence interval.	through study completion, an average of 3 year
Secondary	Prevalence of children with HV-Labile	Estimated and provided with its 95% confidence interval.	through study completion, an average of 3 year
Secondary	Correlation coefficient between the symptomatic proprioceptive questionnaire and the presence of HV-Labile	Estimated and provided with its 95% confidence interval.	through study completion, an average of 3 year
Secondary	Positive predictive values	Estimated and provided with its 95% confidence interval.	through study completion, an average of 3 year
Secondary	Negative predictive values	Estimated and provided with its 95% confidence interval.	through study completion, an average of 3 year

External Links

•   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.