Developmental Dyslexia Clinical Trial
— Pro-Pho-DysOfficial title:
Remédiation Orthophonique couplée à Une Prise en Charge Proprioceptive de la Dyslexie. Etude Comparative randomisée
Verified date | March 2020 |
Source | Scalab CNRS 9193 |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
Status | Active, not recruiting |
Enrollment | 26 |
Est. completion date | October 10, 2020 |
Est. primary completion date | October 5, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 9 Years to 14 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
France | Scalab CNRS 9193 | Villeneuve-d'Ascq | Haut De France |
Lead Sponsor | Collaborator |
---|---|
Scalab CNRS 9193 |
France,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline C index ( Alouatte-R test) at 9 months | Number of correctly read words (standard deviation) | Baseline, at nine months | |
Secondary | Change from baseline TL index ( Alouatte-R test) at 9 months | Reading time in second (TL) (standard deviation) | Baseline, at nine months | |
Secondary | Change from baseline M index ( Alouatte-R test) at 9 months | Number of words read (M)(standard deviation) | Baseline, at nine months | |
Secondary | Change from baseline E index ( Alouatte-R test) at 9 months | Number of errors (E)(standard deviation) | Baseline, at nine months | |
Secondary | Change from baseline CM index ( Alouatte-R test) at 9 months | Precision index (CM)(standard deviation) | Baseline, at nine months | |
Secondary | Change from baseline CTL index ( Alouatte-R test) at 9 months | Speed index (CTL)(standard deviation) | Baseline, at nine months | |
Secondary | Change from baseline Regular ODEDYS test at 9 months | Regular words reading, Screening tools for dyslexia (ODEDYS)(standard deviation) | Baseline, at nine months | |
Secondary | Change from baseline Irregular ODEDYS test at 9 months | Irregular words reading (standard deviation) | Baseline, at nine months | |
Secondary | change from baseline Pseudo-words ODEDYS test at 9 months | Pseudo-words reading (standard deviation) | Baseline, at nine months | |
Secondary | 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 | |
Secondary | Change from baseline DL VOG at 9 months | Duration of look (DL), of the measured reading in Video Oculography (VOG), | Baseline, at nine months | |
Secondary | Change from baseline TFT VOG at 9 months | Total fixation time (TFT), of the measured reading in Video Oculography (VOG), | Baseline, at nine months | |
Secondary | 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 | |
Secondary | 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 |
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