CClinicalTrials.gg
Status unknownNCT03448237Pro-Pho-DysUpdated Mar 17, 2020

Orthophonic and / or Proprioceptive Treatment of Developmental Dyslexia.

An interventional study of Speech Therapy and Proprioceptive treatment in Developmental Dyslexia, sponsored by Scalab CNRS 9193. Status unknown at 1 site in France. Open to participants aged 9 Years to 14 Years. Per ClinicalTrials.gov, last updated 2020-03-17.

Sponsored by Scalab CNRS 9193 · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
9 Years to 14 Years
Sex
All
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Study 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)

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Conditions studied

  • Developmental Dyslexia

Browse trials for

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Who can participate

Ages eligible
9 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Refractive correction above +/- 1.5 diopters.
  • Absence of binocular vision.
  • Amblyopia.
  • Convulsion.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
26 participants (estimated)

Study arms

  • Active comparator
    Speech therapy

    Speech therapy adapted to the child,

    Other: Speech Therapy

  • Experimental
    Combined Treatment

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

    Other: Speech Therapy · Other: Proprioceptive treatment

Interventions

  • OtherSpeech Therapy

    Speech therapy adapted to the child, at least 25 sessions over 9 months.

    Also known as: Orthophonic treatment

  • OtherProprioceptive 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)

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What researchers measure

Primary outcomes

  1. Change from baseline C index ( Alouatte-R test) at 9 months

    Number of correctly read words (standard deviation)

    Time frame: Baseline, at nine months

Secondary outcomes

  1. Change from baseline TL index ( Alouatte-R test) at 9 months

    Reading time in second (TL) (standard deviation)

    Time frame: Baseline, at nine months

  2. Change from baseline M index ( Alouatte-R test) at 9 months

    Number of words read (M)(standard deviation)

    Time frame: Baseline, at nine months

  3. Change from baseline E index ( Alouatte-R test) at 9 months

    Number of errors (E)(standard deviation)

    Time frame: Baseline, at nine months

  4. Change from baseline CM index ( Alouatte-R test) at 9 months

    Precision index (CM)(standard deviation)

    Time frame: Baseline, at nine months

  5. Change from baseline CTL index ( Alouatte-R test) at 9 months

    Speed index (CTL)(standard deviation)

    Time frame: Baseline, at nine months

  6. Change from baseline Regular ODEDYS test at 9 months

    Regular words reading, Screening tools for dyslexia (ODEDYS)(standard deviation)

    Time frame: Baseline, at nine months

  7. Change from baseline Irregular ODEDYS test at 9 months

    Irregular words reading (standard deviation)

    Time frame: Baseline, at nine months

  8. change from baseline Pseudo-words ODEDYS test at 9 months

    Pseudo-words reading (standard deviation)

    Time frame: Baseline, at nine months

  9. Change from base line DFF VOG at 9 months

    Duration of first fixation (DFF), of the measured reading in Video Oculography (VOG),

    Time frame: Baseline, at nine months

  10. Change from baseline DL VOG at 9 months

    Duration of look (DL), of the measured reading in Video Oculography (VOG),

    Time frame: Baseline, at nine months

  11. Change from baseline TFT VOG at 9 months

    Total fixation time (TFT), of the measured reading in Video Oculography (VOG),

    Time frame: Baseline, at nine months

  12. 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

    Time frame: Baseline, at nine months

  13. Vertical orthophoria

    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

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Study locations

1 site
  • Scalab CNRS 9193
    Villeneuve-d'Ascq, Haut De France 59653, France
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References and documents

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. PubMed 26445526 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT03448237
Lead sponsor
Scalab CNRS 9193
Responsible party
Luc-Marie Virlet (Coordinating Investigator, Scalab CNRS 9193) — Principal investigator
First posted
Feb 28, 2018
Start date
Feb 17, 2018
Primary completion
Oct 5, 2019
Completion
Oct 10, 2020 (estimated)
Last update
Mar 17, 2020

Study contacts

Laurent Sparrow, MCF
study director · Scalab CNRS 9193, Lille University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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