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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03448237
Other study ID # Scalab 2015-024EL
Secondary ID ID RCB : 2015-A0
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 17, 2018
Est. completion date October 10, 2020

Study information

Verified date March 2020
Source Scalab CNRS 9193
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Speech Therapy
Speech therapy adapted to the child, at least 25 sessions over 9 months.
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)

Locations

Country Name City State
France Scalab CNRS 9193 Villeneuve-d'Ascq Haut De France

Sponsors (1)

Lead Sponsor Collaborator
Scalab CNRS 9193

Country where clinical trial is conducted

France, 

References & Publications (1)

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

Outcome

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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