- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04070625
Communication Book in Pragmatic Communication in Vascular Aphasics (APHACOM)
Evaluation of the Effectiveness of a Communication Book in Pragmatic Communication in Vascular Aphasics During the First Year Post-Stroke
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Data from the literature have demonstrated the effectiveness of speech therapy in aphasic vascular. In the face of sequelae, particularly in the most serious aphasia, a palliative approach aims to increase the functional effectiveness of communication in everyday life. The communication book has been developed in this perspective, addressing aphasics whose language communication skills are greatly reduced. Early use in this trial is warranted by implantation prior to the onset of potentially deleterious compensatory mechanisms seen in the late-stage aphasic sequelae.
This study aims to evaluate, in communication tasks, the pragmatic effectiveness of the communication book in the general conditions of use and its maintenance in the implementation of the compensatory strategies of communication in severe aphasias.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Informed consent after information. Information is also given to the person of trust when it exists.
- aphasic subjects admitted to hospital or seen in consultation following a 1st ischemic or hemorrhagic symptomatic vascular accident constituted
- during the first year of onset of aphasia
- adults over 18 years old
- French
- phasic disorder of severe severity expression (overall severity score between 0 and 2 at the diagnostic battery for the assessment of aphasia scale)
- residual ability to understand clinical assessments and informed consent; information about the objectives and the procedure of the research will also be given to the patient's designated confidant
- motor capacity for comfortable sitting and transfers with help
- affiliation to health insurance
- no deficits in visual perceptual tests (researched using the visual decision of objects and Montreal protocol for the evaluation of visual gnosis), which allows the use of the communication book,
Exclusion Criteria:
- refusal or impossibility of consent
- disturbance of vigilance
- insane state
- psychiatric history requiring hospitalization in a specialized environment
- perceptual disturbance, visual agnosia not allowing the use of the image support
- pregnancy or breastfeeding
- administration after the occurrence of stroke of a product for which an effect on the recovery of aphasia has been reported: piracetam, bromocriptine, donepezil, dextroamphetamine (if treatment with these products has been performed, inclusion is possible after a weaning period of 15 days)
- simultaneous inclusion in another therapeutic protocol of language disorders
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Communication book group
Speech therapy with communication book
|
Communication book
|
|
Control group
Simple speech therapy
|
Simple speech therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of successful tasks in the communication book
Time Frame: At Day 45 after stroke
|
Communication book of Gonzales et al, with 6 tasks
|
At Day 45 after stroke
|
|
Number of successful tasks in the communication book
Time Frame: At Day 90 after stroke
|
Communication book of Gonzales et al, with 6 tasks
|
At Day 90 after stroke
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pierre-Alain JOSEPH, Pr, University Hospital, Bordeaux
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2008/10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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