Clinical Trial: Study of the Interest of Proprioceptive Therapy as a Complement to Speech Therapy in Children With Reading Difficulties
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Study of the Interest of Proprioceptive Therapy as a Complement to Speech Therapy in Children With Reading Difficulties
Brief 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 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.
Detailed Summary:
Sponsor: Centre Hospitalier Universitaire Dijon
Current 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Centre Hospitalier Universitaire Dijon
Dates:
Date Received: August 5, 2016
Date Started: September 2015
Date Completion:
Last Updated: August 5, 2016
Last Verified: July 2016
