Study of the Interest of Proprioceptive Therapy as a Complement to Speech Therapy in Children With Reading Difficulties

Reading Difficulties Clinical Trial

— 2000DYS9  

Official title:

Study of the Interest of Proprioceptive Therapy as a Complement to Speech Therapy in Children With Reading Difficulties

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02861599
• Other study ID #: QUERCIA INSERM 2015
• Status: Recruiting
• Phase: N/A
• First received: August 5, 2016
• Last updated: August 5, 2016
• Start date: September 2015

Study information

• Verified date: July 2016
• Source: Centre Hospitalier Universitaire Dijon
• Contact: Patrick QUERCIA
• Phone: 03.80.24.68.74
• Email: docteur.quercia[@]neuf.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 11 Years

Eligibility

Inclusion Criteria:

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.

• 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.

Exclusion Criteria:

• 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

• 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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Communication Disorders
• Reading Difficulties

Intervention

Other:
• proprioceptive therapy

• speech therapy

Locations

Country	Name	City	State
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of children who had stabilized their delay in reading acquisition at the Timé-3 test (identification of written words)		At month12	No