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Study of Hierarchy of Afferents in Postural Control of Children With Dyslexia (EQUIDYS)

Primary Purpose

Dyslexia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Posturographic tests
Questionnaire of motion sickness susceptibility
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dyslexia

Eligibility Criteria

8 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

All:

  • Parents of child and child having given informed consent
  • Affiliation to social security
  • Preliminary medical examination

Dyslexia groups:

- Diagnosed and characterized dyslexia

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Phonological dyslexia

Visuo-attentional dyslexia

Control

Arm Description

Children with phonological dyslexia

Children with visuo-attentional dyslexia

Control children, age-matched

Outcomes

Primary Outcome Measures

Score of evaluation of motion sickness susceptibility
Score of equilibrium evaluated with posturographic test

Secondary Outcome Measures

Full Information

First Posted
August 23, 2016
Last Updated
August 23, 2016
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT02879786
Brief Title
Study of Hierarchy of Afferents in Postural Control of Children With Dyslexia
Acronym
EQUIDYS
Official Title
Study of Hierarchy of Afferents in Postural Control of Children With Dyslexia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This study evaluates the postural control and the importance of proprioception, evaluated by static and dynamic posturography, in dyslexic children compared to age-matched control group. Posturographic data and a questionnaire for motion sickness disorder are used as proprioceptive disorder index. This study aims to better characterize the dyslexic population with techniques targeting central integration of sensory proprioceptive afferents. The purpose of this study is not to search for a postural deficiency syndrome, but to study proprioception with posturography, with quantitative and normalized data of analyzed population. Moreover, these data could allow an objective evaluation of reeducation with quantifiable and reproducible parameters in order to judge its effectiveness. The demonstration of the existence of a relationship between proprioceptive disorders and dyslexia will imply a specific reeducation care of patients. A study using validated and standard indexes is necessary. The presence of postural disorders and a major susceptibility to motion sickness could contribute to distinguish different forms of dyslexia and thus be complementary to actual medical, orthophonic and neuropsychological criteria. In this evaluation, it is important to distinguish between visuo-attentional dyslexia from phonological dyslexia involving distinct anatomo-functional neuronal circuits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslexia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phonological dyslexia
Arm Type
Experimental
Arm Description
Children with phonological dyslexia
Arm Title
Visuo-attentional dyslexia
Arm Type
Experimental
Arm Description
Children with visuo-attentional dyslexia
Arm Title
Control
Arm Type
Other
Arm Description
Control children, age-matched
Intervention Type
Other
Intervention Name(s)
Posturographic tests
Intervention Type
Other
Intervention Name(s)
Questionnaire of motion sickness susceptibility
Primary Outcome Measure Information:
Title
Score of evaluation of motion sickness susceptibility
Time Frame
day 0
Title
Score of equilibrium evaluated with posturographic test
Time Frame
day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All: Parents of child and child having given informed consent Affiliation to social security Preliminary medical examination Dyslexia groups: - Diagnosed and characterized dyslexia Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe PERRIN, Pr
Organizational Affiliation
INSERM U954 and Consultation ORL, Hôpital d'Enfants - CHU de Nancy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de Référence pour les Troubles des Apprentissages - Hôpital d'Enfants - CHU de Nancy
City
Vandoeuvre lès Nancy
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of Hierarchy of Afferents in Postural Control of Children With Dyslexia

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