Specific Developmental Disorders of Speech and LanguageTDysNCT04122820
Ambulatory Screening for Specific Learning Disabilities (SLD) and Developmental Coordination Disorder (DCD).
A study testing Diagnostic of specific learning disabilities or of Developmental Coordination Disorder in people with Specific Developmental Disorders of Speech and Language and Specific Learning Disorder, run by CNGE IRMG Association at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Specific Developmental Disorders of Speech and Language, Specific Learning Disorder, Dyslexia, Developmental
- What is being tested?
- Diagnostic of specific learning disabilities or of Developmental Coordination Disorder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 1 siteFrance
- Study dates
- 16 Oct 2019to 30 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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))
Show all 20Show fewer
- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Office-based general practioner
Strasbourg, Alsace, 67000
Luc Virlet, +33678296310, virlet.luc@laposte.net
About this study
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).
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.
- Conditions
- Specific Developmental Disorders of Speech and Language, Specific Learning Disorder, Dyslexia, Developmental, Developmental Coordination Disorder, Dyspraxia
- Being tested
- Diagnostic of specific learning disabilities or of Developmental Coordination Disorder
- Keywords
- Specific Learning Disorder, Developmental Coordination Disorder, Specific Developmental Disorders of Speech and Language, Dyslexia, Developmental, Dyspraxia
- Medical subject headings
- Language, Specific Learning Disorder, Dyslexia, Motor Skills Disorders, Apraxias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic of specific learning disabilities or of Developmental Coordination DisorderDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Presence of HV-Labile | Other | Presence of vertical heterophoria labile with proprioceptive Maddox Receives: Diagnostic Test: Diagnostic of specific learning disabilities or of Developmental Coordination Disorder |
| Absence of HV-Labile | Other | Presence of stable vertical heterophoria or stable orthophoria with proprioceptive Maddox Receives: Diagnostic Test: Diagnostic of specific learning disabilities or of Developmental Coordination Disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the HV-Labile to SLD or DCD
Estimated and provided with its 95% confidence interval.
Measured: through study completion, an average of 3 year
Secondary outcomes (6)
Specificity of the HV-Labile to SLD or DCD
Estimated and provided with its 95% confidence interval.
Measured: through study completion, an average of 3 year
Positive and negative likelihood ratios
Estimated and provided with its 95% confidence interval.
Measured: through study completion, an average of 3 year
Prevalence of children with HV-Labile
Estimated and provided with its 95% confidence interval.
Measured: through study completion, an average of 3 year
Correlation coefficient between the symptomatic proprioceptive questionnaire and the presence of HV-Labile
Estimated and provided with its 95% confidence interval.
Measured: through study completion, an average of 3 year
Positive predictive values
Estimated and provided with its 95% confidence interval.
Measured: through study completion, an average of 3 year
Negative predictive values
Estimated and provided with its 95% confidence interval.
Measured: through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start16 Oct 2019
- Primary completion30 Oct 2021 (estimated)
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Specific Developmental Disorders of Speech and LanguageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CNGE IRMG Association
- Sponsor type
- University, hospital or other
- Collaborators
- Scalab CNRS 9193
- Responsible party
- Principal investigator, Luc Virlet, Scalab CNRS 9193
- Investigators
- Luc Virlet, Principal investigator, SCalab CNRS 9193, Lille University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122820
- Sponsor's protocol ID
- CNGEIRMG 0310
- Other IDs
- 2019-A00416-51
- Acronym
- TDys
- Status last verified
- Oct 2019
- First submitted
- 5 Oct 2019
- Last updated
- 18 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers.
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT04122820
- Acronym / sponsor ID
- TDys / CNGEIRMG 0310
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- CNGE IRMG AssociationUniversity, hospital or other
- Collaborators
- Scalab CNRS 9193
- Study start
- 16 Oct 2019 (actual)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 10 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Presence of HV-Labile | Other | Diagnostic Test: Diagnostic of specific learning disabilities or of Developmental Coordination DisorderPresence of vertical heterophoria labile with proprioceptive Maddox |
| Absence of HV-Labile | Other | Diagnostic Test: Diagnostic of specific learning disabilities or of Developmental Coordination DisorderPresence of stable vertical heterophoria or stable orthophoria with proprioceptive Maddox |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic of specific learning disabilities or of Developmental Coordination DisorderSpeech 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. | Diagnostic test | Absence of HV-Labile, Presence of HV-Labile |
Primary outcome
Sensitivity of the HV-Labile to SLD or DCD
Time frame: through study completion, an average of 3 year
Estimated and provided with its 95% confidence interval.
6 secondary outcomes
Specificity of the HV-Labile to SLD or DCD
Time frame: through study completion, an average of 3 year
Positive and negative likelihood ratios
Time frame: through study completion, an average of 3 year
Prevalence of children with HV-Labile
Time frame: through study completion, an average of 3 year
Correlation coefficient between the symptomatic proprioceptive questionnaire and the presence of HV-Labile
Time frame: through study completion, an average of 3 year
Positive predictive values
Time frame: through study completion, an average of 3 year
Negative predictive values
Time frame: through study completion, an average of 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2019.
- Results publication: PubMed 26445526Quercia 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.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers.
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Recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luc Virlet principal investigator
SCalab CNRS 9193, Lille University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic of specific learning disabilities or of Developmental Coordination Disorder in people with Specific Developmental Disorders of Speech and Language and Specific Learning Disorder, run by CNGE IRMG Association at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luc Virlet (+33678296310, virlet.luc@laposte.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the HV-Labile to SLD or DCD (time frame: through study completion, an average of 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04122820, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2019.