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Orthophonic and / or Proprioceptive Treatment of Developmental Dyslexia. (Pro-Pho-Dys)

Primary Purpose

Developmental Dyslexia

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Speech Therapy
Proprioceptive treatment
Sponsored by
Scalab CNRS 9193
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Developmental Dyslexia

Eligibility Criteria

9 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Scalab CNRS 9193

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Speech therapy

Combined Treatment

Arm Description

Speech therapy adapted to the child,

Association of speech therapy and proprioceptive treatment, adapted to the child.

Outcomes

Primary Outcome Measures

Change from baseline C index ( Alouatte-R test) at 9 months
Number of correctly read words (standard deviation)

Secondary Outcome Measures

Change from baseline TL index ( Alouatte-R test) at 9 months
Reading time in second (TL) (standard deviation)
Change from baseline M index ( Alouatte-R test) at 9 months
Number of words read (M)(standard deviation)
Change from baseline E index ( Alouatte-R test) at 9 months
Number of errors (E)(standard deviation)
Change from baseline CM index ( Alouatte-R test) at 9 months
Precision index (CM)(standard deviation)
Change from baseline CTL index ( Alouatte-R test) at 9 months
Speed index (CTL)(standard deviation)
Change from baseline Regular ODEDYS test at 9 months
Regular words reading, Screening tools for dyslexia (ODEDYS)(standard deviation)
Change from baseline Irregular ODEDYS test at 9 months
Irregular words reading (standard deviation)
change from baseline Pseudo-words ODEDYS test at 9 months
Pseudo-words reading (standard deviation)
Change from base line DFF VOG at 9 months
Duration of first fixation (DFF), of the measured reading in Video Oculography (VOG),
Change from baseline DL VOG at 9 months
Duration of look (DL), of the measured reading in Video Oculography (VOG),
Change from baseline TFT VOG at 9 months
Total fixation time (TFT), of the measured reading in Video Oculography (VOG),
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
Vertical orthophoria
Comparison of the evolution of reading tests, taking into account the presence or absence of localization instability, whatever the treatment groups.

Full Information

First Posted
February 15, 2018
Last Updated
March 16, 2020
Sponsor
Scalab CNRS 9193
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1. Study Identification

Unique Protocol Identification Number
NCT03448237
Brief Title
Orthophonic and / or Proprioceptive Treatment of Developmental Dyslexia.
Acronym
Pro-Pho-Dys
Official Title
Remédiation Orthophonique couplée à Une Prise en Charge Proprioceptive de la Dyslexie. Etude Comparative randomisée
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 17, 2018 (Actual)
Primary Completion Date
October 5, 2019 (Actual)
Study Completion Date
October 10, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Scalab CNRS 9193

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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)

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Speech therapy
Arm Type
Active Comparator
Arm Description
Speech therapy adapted to the child,
Arm Title
Combined Treatment
Arm Type
Experimental
Arm Description
Association of speech therapy and proprioceptive treatment, adapted to the child.
Intervention Type
Other
Intervention Name(s)
Speech Therapy
Other Intervention Name(s)
Orthophonic treatment
Intervention Description
Speech therapy adapted to the child, at least 25 sessions over 9 months.
Intervention Type
Other
Intervention Name(s)
Proprioceptive treatment
Intervention Description
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)
Primary Outcome Measure Information:
Title
Change from baseline C index ( Alouatte-R test) at 9 months
Description
Number of correctly read words (standard deviation)
Time Frame
Baseline, at nine months
Secondary Outcome Measure Information:
Title
Change from baseline TL index ( Alouatte-R test) at 9 months
Description
Reading time in second (TL) (standard deviation)
Time Frame
Baseline, at nine months
Title
Change from baseline M index ( Alouatte-R test) at 9 months
Description
Number of words read (M)(standard deviation)
Time Frame
Baseline, at nine months
Title
Change from baseline E index ( Alouatte-R test) at 9 months
Description
Number of errors (E)(standard deviation)
Time Frame
Baseline, at nine months
Title
Change from baseline CM index ( Alouatte-R test) at 9 months
Description
Precision index (CM)(standard deviation)
Time Frame
Baseline, at nine months
Title
Change from baseline CTL index ( Alouatte-R test) at 9 months
Description
Speed index (CTL)(standard deviation)
Time Frame
Baseline, at nine months
Title
Change from baseline Regular ODEDYS test at 9 months
Description
Regular words reading, Screening tools for dyslexia (ODEDYS)(standard deviation)
Time Frame
Baseline, at nine months
Title
Change from baseline Irregular ODEDYS test at 9 months
Description
Irregular words reading (standard deviation)
Time Frame
Baseline, at nine months
Title
change from baseline Pseudo-words ODEDYS test at 9 months
Description
Pseudo-words reading (standard deviation)
Time Frame
Baseline, at nine months
Title
Change from base line DFF VOG at 9 months
Description
Duration of first fixation (DFF), of the measured reading in Video Oculography (VOG),
Time Frame
Baseline, at nine months
Title
Change from baseline DL VOG at 9 months
Description
Duration of look (DL), of the measured reading in Video Oculography (VOG),
Time Frame
Baseline, at nine months
Title
Change from baseline TFT VOG at 9 months
Description
Total fixation time (TFT), of the measured reading in Video Oculography (VOG),
Time Frame
Baseline, at nine months
Title
Observation of the evolution of the shape of maxwells spots from baseline at 9 months
Description
From the shape of Maxwell's tasks to the fovea-scope
Time Frame
Baseline, at nine months
Title
Vertical orthophoria
Description
Comparison of the evolution of reading tests, taking into account the presence or absence of localization instability, whatever the treatment groups.
Time Frame
Baseline, at nine months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent Sparrow, MCF
Organizational Affiliation
Scalab CNRS 9193, Lille University
Official's Role
Study Director
Facility Information:
Facility Name
Scalab CNRS 9193
City
Villeneuve-d'Ascq
State/Province
Haut De France
ZIP/Postal Code
59653
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26445526
Citation
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.
Results Reference
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Orthophonic and / or Proprioceptive Treatment of Developmental Dyslexia.

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