NCT02879786

Brief Summary

The purpose is to determine the hierarchy of sensory afferents according to different forms of dyslexia in children. The secondary purpose is to determine sensitive and sufficiently specific posturographic indexes for standard diagnosis of different types of dyslexia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2011

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2016

Completed
Last Updated

August 26, 2016

Status Verified

August 1, 2016

Enrollment Period

3.9 years

First QC Date

August 23, 2016

Last Update Submit

August 23, 2016

Conditions

Dyslexia

Outcome Measures

Primary Outcomes (2)

  • Score of evaluation of motion sickness susceptibility

    day 0

  • Score of equilibrium evaluated with posturographic test

    day 0

Study Arms (3)

Phonological dyslexia

EXPERIMENTAL

Children with phonological dyslexia

Other: Posturographic testsOther: Questionnaire of motion sickness susceptibility

Visuo-attentional dyslexia

EXPERIMENTAL

Children with visuo-attentional dyslexia

Other: Posturographic testsOther: Questionnaire of motion sickness susceptibility

Control

OTHER

Control children, age-matched

Other: Posturographic testsOther: Questionnaire of motion sickness susceptibility

Interventions

Posturographic testsOTHER
ControlPhonological dyslexiaVisuo-attentional dyslexia
Questionnaire of motion sickness susceptibilityOTHER
ControlPhonological dyslexiaVisuo-attentional dyslexia

Eligibility Criteria

Age8 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All:
  • Parents of child and child having given informed consent
  • Affiliation to social security
  • Preliminary medical examination
  • Dyslexia groups:
  • \- Diagnosed and characterized dyslexia

You may not qualify if:

  • All:
  • Medical pathology, especially neurological, ophthalmological, otorhinolaryngological or orthopedic, modifying postural control, detected with medical examination
  • Insufficient compliance of child especially due to fatigue
  • Contact allergy to cutaneous electrodes
  • Current treatments: psychotropic drugs and all drugs diminishing awareness or causing dizziness or equilibrium disorders
  • Control group:
  • \- Patient having a dyslexia or oral or written language disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Référence pour les Troubles des Apprentissages - Hôpital d'Enfants - CHU de Nancy

Vandœuvre-lès-Nancy, France

Location

MeSH Terms

Conditions

Dyslexia

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSpecific Learning DisorderLearning DisabilitiesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Philippe PERRIN, Pr

    INSERM U954 and Consultation ORL, Hôpital d'Enfants - CHU de Nancy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2016

First Posted

August 26, 2016

Study Start

July 1, 2011

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

August 26, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)