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

March 16, 2020 updated by: Luc-Marie Virlet, Scalab CNRS 9193

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline C index ( Alouatte-R test) at 9 months
Time Frame: Baseline, at nine months
Number of correctly read words (standard deviation)
Baseline, at nine months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline TL index ( Alouatte-R test) at 9 months
Time Frame: Baseline, at nine months
Reading time in second (TL) (standard deviation)
Baseline, at nine months
Change from baseline M index ( Alouatte-R test) at 9 months
Time Frame: Baseline, at nine months
Number of words read (M)(standard deviation)
Baseline, at nine months
Change from baseline E index ( Alouatte-R test) at 9 months
Time Frame: Baseline, at nine months
Number of errors (E)(standard deviation)
Baseline, at nine months
Change from baseline CM index ( Alouatte-R test) at 9 months
Time Frame: Baseline, at nine months
Precision index (CM)(standard deviation)
Baseline, at nine months
Change from baseline CTL index ( Alouatte-R test) at 9 months
Time Frame: Baseline, at nine months
Speed index (CTL)(standard deviation)
Baseline, at nine months
Change from baseline Regular ODEDYS test at 9 months
Time Frame: Baseline, at nine months
Regular words reading, Screening tools for dyslexia (ODEDYS)(standard deviation)
Baseline, at nine months
Change from baseline Irregular ODEDYS test at 9 months
Time Frame: Baseline, at nine months
Irregular words reading (standard deviation)
Baseline, at nine months
change from baseline Pseudo-words ODEDYS test at 9 months
Time Frame: Baseline, at nine months
Pseudo-words reading (standard deviation)
Baseline, at nine months
Change from base line DFF VOG at 9 months
Time Frame: Baseline, at nine 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
Time Frame: Baseline, at nine 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
Time Frame: Baseline, at nine 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
Time Frame: Baseline, at nine months
From the shape of Maxwell's tasks to the fovea-scope
Baseline, at nine months
Vertical orthophoria
Time Frame: Baseline, at nine months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Scalab CNRS 9193

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Laurent Sparrow, MCF, Scalab CNRS 9193, Lille University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 17, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 5, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 10, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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