Reading Difficulties2000DYS9NCT02861599
Study of the Interest of Proprioceptive Therapy as a Complement to Speech Therapy in Children With Reading Difficulties
A study testing proprioceptive therapy and speech therapy in people with Reading Difficulties, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Before proposing this observational study protocol, a randomized study was attempted. This consisted in proposing to families of children with difficulties in learning to read, via the speech therapists who were treating them, to take part in a randomized trial that compared speech therapy alone with a combination of… Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Reading Difficulties
- What is being tested?
- proprioceptive therapy and speech therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to Jul 2017
- 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 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- For both groups:
- children at school and between the end of year 3 and the end of year 7
- with speech therapy for reading difficulties
- with a delay of 18 months or more compared with children in the same group at inclusion
- who had never had proprioceptive therapy
- in cases of two or more siblings with reading difficulties between year 3 and year 8, only one child will be included.
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- With one speech therapy session per week
- Who have accepted to take part in the study in agreement with their parents
- With national health insurance cover For the " speech therapy only" cohort: children followed by speech therapists who do not usually refer their patients to ophthalmologists that use proprioceptive therapy in cases of delayed reading acquisition and have not previously consulted an ophthalmologist proposing this type of therapy.
- For the " speech therapy associated with proprioceptive therapy " cohort: children with reading difficulties followed by a speech therapist and consulting for the first time an ophthalmologist, study investigator, who uses proprioceptive therapy in the treatment of reading difficulties.
Who cannot join
- Children who lack motivation and/or and those unlikely to be followed in optimal conditions
- Neonatal distress: APGAR <7
- Gestational age < 37 weeks of Amenorrhea (WA)
- Genetic disease
- Known abnormal or delay in psychomotor development
- Psychiatric disorder
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- Sensory deficit or disorder known to limit the possibilities of proprioceptive therapy
- Children undergoing treatment, notably psychotropic agents, Ritaline®, antiepileptic agents or rehabilitation, which may interfere with reading difficulties or the therapy proposed in the study
- Children in special needs schools (SEGPA)
- Children who cannot attend all of the consultations planned in the protocol for practical reasons.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Dijon Bourgogne
Dijon, 21079
Patrick QUERCIA, 03 80 24 68 74 ext. +33, docteur.quercia@neuf.fr
About this study
Before proposing this observational study protocol, a randomized study was attempted. This consisted in proposing to families of children with difficulties in learning to read, via the speech therapists who were treating them, to take part in a randomized trial that compared speech therapy alone with a combination of speech therapy and proprioceptive therapy. If parents agreed in principle with the study, the child underwent a complementary speech therapy examination and was referred to the nearest investigating doctor for inclusion. However, this study had to be abandoned because of insufficient recruitment (2 patients included in 1 year). Despite the motivation and training of participating speech therapists, proposing a study based on randomization to families often in distress proved to be extremely difficult, as their conviction of the interest of proprioceptive therapy was greater than the available scientific evidence suggested. Direct recruitment by investigating ophthalmologists was not possible because they were consulted directly by the families so as to obtain proprioceptive therapy. The principle of randomization would thus not have been accepted.
In light of the above, we decided to turn towards a non-randomized study comparing outcomes in two groups of children:
- children who consulted an ophthalmologist who proposed proprioceptive therapy in Côte d'Or
- children managed by one of the four speech therapists who do not propose proprioceptive therapy and who accepted the principle of the study.
- Conditions
- Reading Difficulties
- Being tested
- proprioceptive therapy, speech therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proprioceptive therapyOther
speech therapyOther
| Study group | Role | What they receive |
|---|---|---|
| proprioceptive therapy | Experimental | Not described Receives: Other: proprioceptive therapy; Other: speech therapy |
| speech therapy | Placebo comparator | Not described Receives: Other: speech therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of children who had stabilized their delay in reading acquisition at the Timé-3 test (identification of written words)
Measured: At month12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study startSep 2015
- Primary completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reading DifficultiesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861599
- Sponsor's protocol ID
- QUERCIA INSERM 2015
- Acronym
- 2000DYS9
- Status last verified
- Jul 2016
- First submitted
- 5 Aug 2016
- Last updated
- 10 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Interest of Proprioceptive Therapy as a Complement to Speech Therapy in Children With Reading Difficulties
- ClinicalTrials.gov ID
- NCT02861599
- Acronym / sponsor ID
- 2000DYS9 / QUERCIA INSERM 2015
- Conditions
- Reading Difficulties
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jul 2017 (estimated)
- First posted
- 10 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.
Before proposing this observational study protocol, a randomized study was attempted. This consisted in proposing to families of children with difficulties in learning to read, via the speech therapists who were treating them, to take part in a randomized trial that compared speech therapy alone with a combination of speech therapy and proprioceptive therapy. If parents agreed in principle with the study, the child underwent a complementary speech therapy examination and was referred to the nearest investigating doctor for inclusion. However, this study had to be abandoned because of insufficient recruitment (2 patients included in 1 year). Despite the motivation and training of participating speech therapists, proposing a study based on randomization to families often in distress proved to be extremely difficult, as their conviction of the interest of proprioceptive therapy was greater than the available scientific evidence suggested. Direct recruitment by investigating ophthalmologists was not possible because they were consulted directly by the families so as to obtain proprioceptive therapy. The principle of randomization would thus not have been accepted.
In light of the above, we decided to turn towards a non-randomized study comparing outcomes in two groups of children:
- children who consulted an ophthalmologist who proposed proprioceptive therapy in Côte d'Or
- children managed by one of the four speech therapists who do not propose proprioceptive therapy and who accepted the principle of the study.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| proprioceptive therapy | Experimental | Other: proprioceptive therapy, Other: speech therapy |
| speech therapy | Placebo comparator | Other: speech therapy |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- children at school and between the end of year 3 and the end of year 7
- with speech therapy for reading difficulties
- with a delay of 18 months or more compared with children in the same group at inclusion
- who had never had proprioceptive therapy
- in cases of two or more siblings with reading difficulties between year 3 and year 8, only one child will be included.
Key exclusion criteria (10 listed)
- Children who lack motivation and/or and those unlikely to be followed in optimal conditions
- Neonatal distress: APGAR <7
- Gestational age < 37 weeks of Amenorrhea (WA)
- Genetic disease
- Known abnormal or delay in psychomotor development
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 |
|---|---|---|
| proprioceptive therapy | Other | proprioceptive therapy |
| speech therapy | Other | proprioceptive therapy, speech therapy |
Primary outcome
Percentage of children who had stabilized their delay in reading acquisition at the Timé-3 test (identification of written words)
Time frame: At month12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing proprioceptive therapy and speech therapy in people with Reading Difficulties, run by Centre Hospitalier Universitaire Dijon 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 10 inclusion and 10 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 10 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. Some participants in this study may receive a placebo. 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?
Contact Patrick QUERCIA (03.80.24.68.74 ext. +33, docteur.quercia@neuf.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of children who had stabilized their delay in reading acquisition at the Timé-3 test (identification of written words) (time frame: At month12). 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 10 Aug 2016.