Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 22 of 60 for:    Dyslexia

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03448237
Recruitment Status : Active, not recruiting
First Posted : February 28, 2018
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Luc-Marie Virlet, Scalab CNRS 9193

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)


Condition or disease Intervention/treatment Phase
Developmental Dyslexia Other: Speech Therapy Other: Proprioceptive treatment Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Remédiation Orthophonique couplée à Une Prise en Charge Proprioceptive de la Dyslexie. Etude Comparative randomisée
Actual Study Start Date : February 17, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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)





Primary Outcome Measures :
  1. Change from baseline C index ( Alouatte-R test) at 9 months [ Time Frame: Baseline, at nine months ]
    Number of correctly read words (standard deviation)


Secondary Outcome Measures :
  1. Change from baseline TL index ( Alouatte-R test) at 9 months [ Time Frame: Baseline, at nine months ]
    Reading time in second (TL) (standard deviation)

  2. Change from baseline M index ( Alouatte-R test) at 9 months [ Time Frame: Baseline, at nine months ]
    Number of words read (M)(standard deviation)

  3. Change from baseline E index ( Alouatte-R test) at 9 months [ Time Frame: Baseline, at nine months ]
    Number of errors (E)(standard deviation)

  4. Change from baseline CM index ( Alouatte-R test) at 9 months [ Time Frame: Baseline, at nine months ]
    Precision index (CM)(standard deviation)

  5. Change from baseline CTL index ( Alouatte-R test) at 9 months [ Time Frame: Baseline, at nine months ]
    Speed index (CTL)(standard deviation)

  6. 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)

  7. Change from baseline Irregular ODEDYS test at 9 months [ Time Frame: Baseline, at nine months ]
    Irregular words reading (standard deviation)

  8. change from baseline Pseudo-words ODEDYS test at 9 months [ Time Frame: Baseline, at nine months ]
    Pseudo-words reading (standard deviation)

  9. 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),

  10. 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),

  11. 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),

  12. 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

  13. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   9 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03448237


Locations
Layout table for location information
France
Scalab CNRS 9193
Villeneuve-d'Ascq, Haut De France, France, 59653
Sponsors and Collaborators
Scalab CNRS 9193
Investigators
Layout table for investigator information
Study Director: Laurent Sparrow, MCF Scalab CNRS 9193, Lille University

Publications:
Layout table for additonal information
Responsible Party: Luc-Marie Virlet, Coordinating Investigator, Scalab CNRS 9193
ClinicalTrials.gov Identifier: NCT03448237     History of Changes
Other Study ID Numbers: Scalab 2015-024EL
ID RCB : 2015-A01792-47 ( Other Identifier: ANSM, France )
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Dyslexia
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Learning Disorders
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders