Orthophonic and / or Proprioceptive Treatment of Developmental Dyslexia.

Study Overview
=================
Brief Summary
-----------------
To show the interest of the association of proprioceptive and orthophonic care of dyslexic children. The assumption is that proprioceptive support by correcting a centrally located spatial localization instability restores the ability to automate. It allows a gain of effectiveness of the orthophonic remediation of the reading of dyslexic children. Interventional comparative study over 9 months, of three modes of care: Speech-language, or proprioceptive, or combined (speech therapy or proprioceptive)

Official Title
-----------------
Remédiation Orthophonique couplée à Une Prise en Charge Proprioceptive de la Dyslexie. Etude Comparative randomisée

Conditions
-----------------
Developmental Dyslexia

Intervention / Treatment
-----------------
* Other: Speech Therapy
* Other: Proprioceptive treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Developmental dyslexia, (CIM-10) Having benefited from 2 years of speech therapy. Pathological reading delay of more than 24 months or -2 standard deviations. Either in the course of orthophonic care, or having stopped any orthophonic care. Exclusion Criteria: Refractive correction above +/- 1.5 diopters. Absence of binocular vision. Amblyopia. Convulsion.

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Interventional comparative study over 9 months, of three modes of care: Speech-language, or proprioceptive, or combined (speech therapy or proprioceptive); In view of the lack of recruitment of dyslexic children who had stopped speech therapy, we decided to keep only two comparative arms to our study: of two modes of care: Speech-language, or combined (speech therapy or proprioceptive)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Speech therapy<br>Speech therapy adapted to the child, | Other: Speech Therapy<br>* Speech therapy adapted to the child, at least 25 sessions over 9 months.<br>* Other names: Orthophonic treatment;|
| Experimental: Combined Treatment<br>Association of speech therapy and proprioceptive treatment, adapted to the child. | Other: Speech Therapy<br>* Speech therapy adapted to the child, at least 25 sessions over 9 months.<br>* Other names: Orthophonic treatment;Other: Proprioceptive treatment<br>* Proprioceptive treatment adapted to the child. This treatment aims to stabilize a central reference instability revealed to Maddox Postural by the use of neurosensory decoys:: Proprioceptive stimulation of oculomotor muscles (active prisms). Oral somatosensory stimulation (ALPH). Proprioceptive antigravity stimulation (proprioceptive sole). Proprioceptive reprogramming exercise. Following the teaching of the University Diploma: Perception-Action, Learning Disorders (University of Bourgogne, France)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline C index ( Alouatte-R test) at 9 months | Number of correctly read words (standard deviation) | Baseline, at nine months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline TL index ( Alouatte-R test) at 9 months | Reading time in second (TL) (standard deviation) | Baseline, at nine months | 
| Change from baseline M index ( Alouatte-R test) at 9 months | Number of words read (M)(standard deviation) | Baseline, at nine months | 
| Change from baseline E index ( Alouatte-R test) at 9 months | Number of errors (E)(standard deviation) | Baseline, at nine months | 
| Change from baseline CM index ( Alouatte-R test) at 9 months | Precision index (CM)(standard deviation) | Baseline, at nine months | 
| Change from baseline CTL index ( Alouatte-R test) at 9 months | Speed index (CTL)(standard deviation) | Baseline, at nine months | 
| Change from baseline Regular ODEDYS test at 9 months | Regular words reading, Screening tools for dyslexia (ODEDYS)(standard deviation) | Baseline, at nine months | 
| Change from baseline Irregular ODEDYS test at 9 months | Irregular words reading (standard deviation) | Baseline, at nine months | 
| change from baseline Pseudo-words ODEDYS test at 9 months | Pseudo-words reading (standard deviation) | Baseline, at nine months | 
| Change from base line DFF VOG at 9 months | Duration of first fixation (DFF), of the measured reading in Video Oculography (VOG), | Baseline, at nine months | 
| Change from baseline DL VOG at 9 months | Duration of look (DL), of the measured reading in Video Oculography (VOG), | Baseline, at nine months | 
| Change from baseline TFT VOG at 9 months | Total fixation time (TFT), of the measured reading in Video Oculography (VOG), | Baseline, at nine months | 
| Observation of the evolution of the shape of maxwells spots from baseline at 9 months | From the shape of Maxwell's tasks to the fovea-scope | Baseline, at nine months | 
| Vertical orthophoria | Comparison of the evolution of reading tests, taking into account the presence or absence of localization instability, whatever the treatment groups. | Baseline, at nine months |