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

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

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)

Study Overview

• Status: Unknown
• Conditions: Developmental Dyslexia
• Intervention / Treatment: Other: Speech Therapy; Other: Proprioceptive treatment

• Study Type: Interventional
• Enrollment (Anticipated): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Haut De France
    • Villeneuve-d'Ascq, Haut De France, France, 59653
      • Scalab CNRS 9193

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Speech therapy; Speech therapy adapted to the child,	Other: Speech Therapy; Speech therapy adapted to the child, at least 25 sessions over 9 months.; Other Names: Orthophonic treatment
Experimental: Combined Treatment; Association of speech therapy and proprioceptive treatment, adapted to the child.	Other: Speech Therapy; Speech therapy adapted to the child, at least 25 sessions over 9 months.; Other Names: Orthophonic treatment; Other: Proprioceptive treatment; 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)

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

Collaborators and Investigators

• Sponsor: Scalab CNRS 9193
• Investigators: Study Director: Laurent Sparrow, MCF, Scalab CNRS 9193, Lille University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2018
• Primary Completion (Actual): October 5, 2019
• Study Completion (Anticipated): October 10, 2020

Study Registration Dates

• First Submitted: February 15, 2018
• First Submitted That Met QC Criteria: February 21, 2018
• First Posted (Actual): February 28, 2018

Study Record Updates

• Last Update Posted (Actual): March 17, 2020
• Last Update Submitted That Met QC Criteria: March 16, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Language Disorders; Communication Disorders; Learning Disabilities; Dyslexia
• Other Study ID Numbers: Scalab 2015-024EL; ID RCB : 2015-A01792-47 (Other Identifier: ANSM, France)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No