DyslexiaEQUIDYSNCT02879786
Study of Hierarchy of Afferents in Postural Control of Children With Dyslexia
A study testing Posturographic tests and Questionnaire of motion sickness susceptibility in people with Dyslexia, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The purpose is to determine the hierarchy of sensory afferents according to different forms of dyslexia in children. The secondary purpose is to determine sensitive and sufficiently specific posturographic indexes for standard diagnosis of different types of dyslexia. Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslexia
- What is being tested?
- Posturographic tests and Questionnaire of motion sickness susceptibility
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2011to Jun 2015
- 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 8 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All:
- Parents of child and child having given informed consent
- Affiliation to social security
- Preliminary medical examination
- Dyslexia groups:
- Diagnosed and characterized dyslexia
Who cannot join
- All:
- Medical pathology, especially neurological, ophthalmological, otorhinolaryngological or orthopedic, modifying postural control, detected with medical examination
- Insufficient compliance of child especially due to fatigue
- Contact allergy to cutaneous electrodes
- Current treatments: psychotropic drugs and all drugs diminishing awareness or causing dizziness or equilibrium disorders
- Control group:
- Patient having a dyslexia or oral or written language disorder
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de Référence pour les Troubles des Apprentissages - Hôpital d'Enfants - CHU de Nancy
Vandœuvre-lès-Nancy
About this study
The purpose is to determine the hierarchy of sensory afferents according to different forms of dyslexia in children.
The secondary purpose is to determine sensitive and sufficiently specific posturographic indexes for standard diagnosis of different types of dyslexia.
Read the detailed description
This study evaluates the postural control and the importance of proprioception, evaluated by static and dynamic posturography, in dyslexic children compared to age-matched control group. Posturographic data and a questionnaire for motion sickness disorder are used as proprioceptive disorder index. This study aims to better characterize the dyslexic population with techniques targeting central integration of sensory proprioceptive afferents. The purpose of this study is not to search for a postural deficiency syndrome, but to study proprioception with posturography, with quantitative and normalized data of analyzed population. Moreover, these data could allow an objective evaluation of reeducation with quantifiable and reproducible parameters in order to judge its effectiveness. The demonstration of the existence of a relationship between proprioceptive disorders and dyslexia will imply a specific reeducation care of patients. A study using validated and standard indexes is necessary. The presence of postural disorders and a major susceptibility to motion sickness could contribute to distinguish different forms of dyslexia and thus be complementary to actual medical, orthophonic and neuropsychological criteria. In this evaluation, it is important to distinguish between visuo-attentional dyslexia from phonological dyslexia involving distinct anatomo-functional neuronal circuits.
- Conditions
- Dyslexia
- Being tested
- Posturographic tests, Questionnaire of motion sickness susceptibility
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posturographic testsOther
Questionnaire of motion sickness susceptibilityOther
| Study group | Role | What they receive |
|---|---|---|
| Phonological dyslexia | Experimental | Children with phonological dyslexia Receives: Other: Posturographic tests; Other: Questionnaire of motion sickness susceptibility |
| Visuo-attentional dyslexia | Experimental | Children with visuo-attentional dyslexia Receives: Other: Posturographic tests; Other: Questionnaire of motion sickness susceptibility |
| Control | Other | Control children, age-matched Receives: Other: Posturographic tests; Other: Questionnaire of motion sickness susceptibility |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of evaluation of motion sickness susceptibility
Measured: day 0
Score of equilibrium evaluated with posturographic test
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startJul 2011
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslexiaStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe PERRIN, Pr, Principal investigator, INSERM U954 and Consultation ORL, Hôpital d'Enfants - CHU de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02879786
- Sponsor's protocol ID
- 2011-A00139-32
- Acronym
- EQUIDYS
- Status last verified
- Aug 2016
- First submitted
- 23 Aug 2016
- Last updated
- 26 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Hierarchy of Afferents in Postural Control of Children With Dyslexia
- ClinicalTrials.gov ID
- NCT02879786
- Acronym / sponsor ID
- EQUIDYS / 2011-A00139-32
- Conditions
- Dyslexia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 26 Aug 2016 (estimated)
- 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.
The purpose is to determine the hierarchy of sensory afferents according to different forms of dyslexia in children.
The secondary purpose is to determine sensitive and sufficiently specific posturographic indexes for standard diagnosis of different types of dyslexia.
Detailed description
This study evaluates the postural control and the importance of proprioception, evaluated by static and dynamic posturography, in dyslexic children compared to age-matched control group. Posturographic data and a questionnaire for motion sickness disorder are used as proprioceptive disorder index. This study aims to better characterize the dyslexic population with techniques targeting central integration of sensory proprioceptive afferents. The purpose of this study is not to search for a postural deficiency syndrome, but to study proprioception with posturography, with quantitative and normalized data of analyzed population. Moreover, these data could allow an objective evaluation of reeducation with quantifiable and reproducible parameters in order to judge its effectiveness. The demonstration of the existence of a relationship between proprioceptive disorders and dyslexia will imply a specific reeducation care of patients. A study using validated and standard indexes is necessary. The presence of postural disorders and a major susceptibility to motion sickness could contribute to distinguish different forms of dyslexia and thus be complementary to actual medical, orthophonic and neuropsychological criteria. In this evaluation, it is important to distinguish between visuo-attentional dyslexia from phonological dyslexia involving distinct anatomo-functional neuronal circuits.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phonological dyslexia | Experimental | Other: Posturographic tests, Other: Questionnaire of motion sickness susceptibilityChildren with phonological dyslexia |
| Visuo-attentional dyslexia | Experimental | Other: Posturographic tests, Other: Questionnaire of motion sickness susceptibilityChildren with visuo-attentional dyslexia |
| Control | Other | Other: Posturographic tests, Other: Questionnaire of motion sickness susceptibilityControl children, age-matched |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Parents of child and child having given informed consent
- Affiliation to social security
- Preliminary medical examination
- Diagnosed and characterized dyslexia
Key exclusion criteria (7 listed)
- Medical pathology, especially neurological, ophthalmological, otorhinolaryngological or orthopedic, modifying postural control, detected with medical examination
- Insufficient compliance of child especially due to fatigue
- Contact allergy to cutaneous electrodes
- Current treatments: psychotropic drugs and all drugs diminishing awareness or causing dizziness or equilibrium disorders
- Patient having a dyslexia or oral or written language disorder
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 |
|---|---|---|
| Posturographic tests | Other | Control, Phonological dyslexia, Visuo-attentional dyslexia |
| Questionnaire of motion sickness susceptibility | Other | Control, Phonological dyslexia, Visuo-attentional dyslexia |
Primary outcome
Score of evaluation of motion sickness susceptibility
Time frame: day 0
Score of equilibrium evaluated with posturographic test
Time frame: day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2016.
- Individual participant dataSharing planned: No
Related trials for Dyslexia
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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.
Philippe PERRIN, Pr principal investigator
INSERM U954 and Consultation ORL, Hôpital d'Enfants - CHU de Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posturographic tests and Questionnaire of motion sickness susceptibility in people with Dyslexia, run by Central Hospital, Nancy, France 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 26 Aug 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Score of evaluation of motion sickness susceptibility (time frame: day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2016.