Developmental DyslexiaPro-Pho-DysNCT03448237
Orthophonic and / or Proprioceptive Treatment of Developmental Dyslexia.
A study testing Speech Therapy and Proprioceptive treatment in people with Developmental Dyslexia, run by Scalab CNRS 9193 at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 9 to 14 years
- Conditions the study is for
- Developmental Dyslexia
- What is being tested?
- Speech Therapy and Proprioceptive treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 17 Feb 2018to 10 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Refractive correction above +/- 1.5 diopters.
- Absence of binocular vision.
- Amblyopia.
- Convulsion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remédiation Orthophonique couplée à Une Prise en Charge Proprioceptive de la Dyslexie. Etude Comparative randomisée
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)
- Conditions
- Developmental Dyslexia
- Being tested
- Speech Therapy, Proprioceptive treatment
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech TherapyOther
Also called Orthophonic treatment
Speech therapy adapted to the child, at least 25 sessions over 9 months.
Proprioceptive treatmentOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Speech therapy | Active comparator | Speech therapy adapted to the child, Receives: Other: Speech Therapy |
| Combined Treatment | Experimental | Association of speech therapy and proprioceptive treatment, adapted to the child. Receives: Other: Speech Therapy; Other: Proprioceptive treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline C index ( Alouatte-R test) at 9 months
Number of correctly read words (standard deviation)
Measured: Baseline, at nine months
Secondary outcomes (13)
Change from baseline TL index ( Alouatte-R test) at 9 months
Reading time in second (TL) (standard deviation)
Measured: Baseline, at nine months
Change from baseline M index ( Alouatte-R test) at 9 months
Number of words read (M)(standard deviation)
Measured: Baseline, at nine months
Change from baseline E index ( Alouatte-R test) at 9 months
Number of errors (E)(standard deviation)
Measured: Baseline, at nine months
Change from baseline CM index ( Alouatte-R test) at 9 months
Precision index (CM)(standard deviation)
Measured: Baseline, at nine months
Change from baseline CTL index ( Alouatte-R test) at 9 months
Speed index (CTL)(standard deviation)
Measured: Baseline, at nine months
Change from baseline Regular ODEDYS test at 9 months
Regular words reading, Screening tools for dyslexia (ODEDYS)(standard deviation)
Measured: Baseline, at nine months
Change from baseline Irregular ODEDYS test at 9 months
Irregular words reading (standard deviation)
Measured: Baseline, at nine months
change from baseline Pseudo-words ODEDYS test at 9 months
Pseudo-words reading (standard deviation)
Measured: Baseline, at nine months
Change from base line DFF VOG at 9 months
Duration of first fixation (DFF), of the measured reading in Video Oculography (VOG),
Measured: Baseline, at nine months
Change from baseline DL VOG at 9 months
Duration of look (DL), of the measured reading in Video Oculography (VOG),
Measured: Baseline, at nine months
Change from baseline TFT VOG at 9 months
Total fixation time (TFT), of the measured reading in Video Oculography (VOG),
Measured: Baseline, at nine months
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
Measured: Baseline, at nine months
Vertical orthophoria
Comparison of the evolution of reading tests, taking into account the presence or absence of localization instability, whatever the treatment groups.
Measured: Baseline, at nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start17 Feb 2018
- Primary completion5 Oct 2019
- Study completion10 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Developmental DyslexiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scalab CNRS 9193
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luc-Marie Virlet, Scalab CNRS 9193
- Investigators
- Laurent Sparrow, MCF, Study director, Scalab CNRS 9193, Lille University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448237
- Sponsor's protocol ID
- Scalab 2015-024EL
- Other IDs
- ID RCB : 2015-A01792-47
- Acronym
- Pro-Pho-Dys
- Status last verified
- Mar 2020
- First submitted
- 15 Feb 2018
- Last updated
- 17 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remédiation Orthophonique couplée à Une Prise en Charge Proprioceptive de la Dyslexie. Etude Comparative randomisée
- ClinicalTrials.gov ID
- NCT03448237
- Acronym / sponsor ID
- Pro-Pho-Dys / Scalab 2015-024EL
- Conditions
- Developmental Dyslexia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Scalab CNRS 9193University, hospital or other
- Study start
- 17 Feb 2018 (actual)
- Primary completion
- 5 Oct 2019 (actual)
- Study completion
- 10 Oct 2020 (estimated)
- First posted
- 28 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Speech therapy | Active comparator | Other: Speech TherapySpeech therapy adapted to the child, |
| Combined Treatment | Experimental | Other: Speech Therapy, Other: Proprioceptive treatmentAssociation of speech therapy and proprioceptive treatment, adapted to the child. |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Refractive correction above +/- 1.5 diopters.
- Absence of binocular vision.
- Amblyopia.
- Convulsion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Speech TherapyAlso: Orthophonic treatmentSpeech therapy adapted to the child, at least 25 sessions over 9 months. | Other | Combined Treatment, Speech therapy |
| Proprioceptive treatmentProprioceptive 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) | Other | Combined Treatment |
Primary outcome
Change from baseline C index ( Alouatte-R test) at 9 months
Time frame: Baseline, at nine months
Number of correctly read words (standard deviation)
13 secondary outcomes
Change from baseline TL index ( Alouatte-R test) at 9 months
Time frame: Baseline, at nine months
Change from baseline M index ( Alouatte-R test) at 9 months
Time frame: Baseline, at nine months
Change from baseline E index ( Alouatte-R test) at 9 months
Time frame: Baseline, at nine months
Change from baseline CM index ( Alouatte-R test) at 9 months
Time frame: Baseline, at nine months
Change from baseline CTL index ( Alouatte-R test) at 9 months
Time frame: Baseline, at nine months
Change from baseline Regular ODEDYS test at 9 months
Time frame: Baseline, at nine months
Change from baseline Irregular ODEDYS test at 9 months
Time frame: Baseline, at nine months
change from baseline Pseudo-words ODEDYS test at 9 months
Time frame: Baseline, at nine months
Change from base line DFF VOG at 9 months
Time frame: Baseline, at nine months
Change from baseline DL VOG at 9 months
Time frame: Baseline, at nine months
Change from baseline TFT VOG at 9 months
Time frame: Baseline, at nine months
Observation of the evolution of the shape of maxwells spots from baseline at 9 months
Time frame: Baseline, at nine months
Vertical orthophoria
Time frame: Baseline, at nine months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Background: PubMed 26445526Quercia 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent Sparrow, MCF study director
Scalab CNRS 9193, Lille University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speech Therapy and Proprioceptive treatment in people with Developmental Dyslexia, run by Scalab CNRS 9193 at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline C index ( Alouatte-R test) at 9 months (time frame: Baseline, at nine months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03448237, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.