NCT03448237

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

February 17, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 28, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2020

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

1.6 years

First QC Date

February 15, 2018

Last Update Submit

March 16, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

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

    Number of correctly read words (standard deviation)

    Baseline, at nine months

Secondary Outcomes (13)

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

    Baseline, at nine months

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

    Baseline, at nine months

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

    Baseline, at nine months

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

    Baseline, at nine months

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

    Baseline, at nine months

  • +8 more secondary outcomes

Study Arms (2)

Speech therapy

ACTIVE COMPARATOR

Speech therapy adapted to the child,

Other: Speech Therapy

Combined Treatment

EXPERIMENTAL

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

Other: Speech TherapyOther: Proprioceptive treatment

Interventions

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

Also known as: Orthophonic treatment
Combined TreatmentSpeech therapy

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)

Combined Treatment

Eligibility Criteria

Age9 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scalab CNRS 9193

Villeneuve-d'Ascq, Haut de France, 59653, France

Location

Related 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.

    PMID: 26445526BACKGROUND

MeSH Terms

Conditions

Dyslexia

Interventions

Speech Therapy

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSpecific Learning DisorderLearning DisabilitiesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language DisordersRehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Laurent Sparrow, MCF

    Scalab CNRS 9193, Lille University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinating Investigator

Study Record Dates

First Submitted

February 15, 2018

First Posted

February 28, 2018

Study Start

February 17, 2018

Primary Completion

October 5, 2019

Study Completion

October 10, 2020

Last Updated

March 17, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations