Ambulatory Screening for Specific Learning Disabilities (SLD) and Developmental Coordination Disorder (DCD).
TDys
Sensitivity of the Search for a Heterophory-Vertical-Labile (HV-Labile) for Ambulatory Screening for Specific Learning Disabilities (SLD) or Developmental Coordination Disorder (DCD).
2 other identifiers
interventional
1,800
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2019
CompletedFirst Posted
Study publicly available on registry
October 10, 2019
CompletedStudy Start
First participant enrolled
October 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2022
CompletedOctober 18, 2019
October 1, 2019
2 years
October 5, 2019
October 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Specificity of the HV-Labile to SLD or DCD
through study completion, an average of 3 year
Positive and negative likelihood ratios
through study completion, an average of 3 year
Prevalence of children with HV-Labile
through study completion, an average of 3 year
Correlation coefficient between the symptomatic proprioceptive questionnaire and the presence of HV-Labile
through study completion, an average of 3 year
Positive predictive values
through study completion, an average of 3 year
- +1 more secondary outcomes
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
through study completion, an average of 3 year
Study Arms (2)
Presence of HV-Labile
OTHERPresence of vertical heterophoria labile with proprioceptive Maddox
Absence of HV-Labile
OTHERPresence of stable vertical heterophoria or stable orthophoria with proprioceptive Maddox
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CNGE IRMG Associationlead
- Scalab CNRS 9193collaborator
Study Sites (1)
Office-based general practioner
Strasbourg, Alsace, 67000, France
Related 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.
PMID: 26445526RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luc Virlet
SCalab CNRS 9193, Lille University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 5, 2019
First Posted
October 10, 2019
Study Start
October 16, 2019
Primary Completion
October 30, 2021
Study Completion
October 30, 2022
Last Updated
October 18, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share
IPD will not be shared with other researchers.