Clinical trial NCT04070625: Communication Book in Pragmatic Communication in Vascular Aphasics
Official title: Evaluation of the Effectiveness of a Communication Book in Pragmatic Communication in Vascular Aphasics During the First Year Post-Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aphasia
Communication
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from the six participating neurological rehabilitation centers, each of which has significant recruitment of aphasic subjects and has a specialized team in the management of language disorders.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of successful tasks in the communication book
timeFrame: At Day 45 after stroke
measure: Number of successful tasks in the communication book
timeFrame: At Day 90 after stroke
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Bordeaux
name: Pierre-Alain JOSEPH, Pr
role: PRINCIPAL_INVESTIGATOR
References: