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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02609542
Other study ID # RC-P0029
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 2014
Est. completion date March 2026

Study information

Verified date June 2023
Source Lille Catholic University
Contact Amélie Lansiaux, MD, PhD
Email lansiaux.amelie@ghicl.net
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The disorder of oral language development is defined by the delay in language acquisition in children who possess efficient auditory acuity and normal non verbal intellect. The diversity of language developement disorders depends either in the expressive level or in the receptive level leading to divers syndromes and symptoms. These syndromes and symptoms are regrouped under the name of STOL (Specific Troubles of Oral Language). In the current project the visual exploitation and learning capability of children presenting a STOL condition will be compared to patients with a normal development. The investigator's hypothesis is as follows: STOL patients for whom the STOL disorder is reduced between 4 and 7 years of age will present a better performance at verbal memorisation, compared to patients with a persistent STOL condition after the age of 6.


Recruitment information / eligibility

Status Recruiting
Enrollment 264
Est. completion date March 2026
Est. primary completion date July 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 45 Months to 95 Months
Eligibility Inclusion Criteria for STOL patients: - Child aged between 45 and 95 months at inclusion - A score > or equal to 5 percentile on the non verbal intelligence test (PM47) - Patient diagnosed with STOL by the neuropediatric medical team - Coverage of the social insurance - Consent form signed by the parents or the legal representative of the child - Normal or corrected sight - Normal hearing Inclusion Criteria for control patients: - Child aged between 45 and 95 months on the day of inclusion - A score > or equal to 5 percentile on the non verbal intelligence test (PM47) - Child who did not receive any speech therapy - Coverage of the social insurance - Consent form signed by the parents or the legal representative of the child - Normal or corrected sight - Normal hearing Exclusion Criteria for STOL patients: - Mother language other than French - Score < to 5 percentile on the non verbal intelligence test (PM47) - Child with pervasive developmental disorder Exclusion Criteria for control patients: - Mother language other than French - Score < to 5 percentile on the non verbal intelligence test (PM47) - Child who received speech therapy

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Eye Tracking
Eye tracker will allows the recording of various information concerning eye fixation (number, duration, location) and saccadic eye movement (speed, range, number, duration) in order to determine the interplay between linguistic and visual information processing during tests performance

Locations

Country Name City State
France Hôpital St Vincent-de-Paul (GHICL) Lille Nord-Pas-de-Calais

Sponsors (1)

Lead Sponsor Collaborator
Lille Catholic University

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes from baseline in the score associated to speech-language outcome measured by a scale grouping results of different questionnaires We will determine if capacities of verbal memory of the children presenting STOL diagnosed at an early stage of their development (before 6 years) are predictive of the evolution of the disorder according to their cognitive profile and more specifically, their language profile as well as their tests performances. To measure the speech language outcome is necessary to take in consideration the score of more than one test performance. 0,12, 24 months
Secondary Changes from baseline in the Raven's Progressive Matrices (RPM) test Raven's Progressive Matrices (RPM) is a test often used in educational settings that is comprised of 60 multiple choice questions. This is a nonverbal test in that the questions are comprised of visual patterns. RPM measures the ability to think clearly about complex ideas and the ability to store and recall information. 0,12, 24 months
Secondary Changes from baseline in the Peabody Picture Vocabulary Test The Peabody Picture Vocabulary Test measures an individual's receptive (hearing) vocabulary and provides, at the same time, a quick estimate of verbal ability or scholastic aptitude. 0,12, 24 months
Secondary Changes from baseline in the number repetition test 0,12, 24 months
Secondary Changes from baseline in the sentences repetition test 0,12, 24 months
Secondary Changes from baseline in the non-words repetition test 0,12, 24 months
Secondary Changes from baseline in the children's eye tracking It is done in order to determine if their is a relation between the evolution of processes involved in verbal memorisation (cognitive mechanisms in charge of data processing).
Eye tracker will allow the recording of information regarding eye fixation (number, duration, location) and saccadic eye movements (speed, range, number, duration) in order to determine the interplay between linguistic and visual information processing during test performances.
0,12, 24 months
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