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Completed

NCT Number: NCT04070625

Communication Book in Pragmatic Communication in Vascular Aphasics

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Communication book group

Other

Communication book

Control Group

Other

Simple speech therapy

Primary outcomes

  1. Number of successful tasks in the communication book

    Time frame: At Day 45 after stroke

    Communication book of Gonzales et al, with 6 tasks

  2. Number of successful tasks in the communication book

    Time frame: At Day 90 after stroke

    Communication book of Gonzales et al, with 6 tasks

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

Evaluation of the Effectiveness of a Communication Book in Pragmatic Communication in Vascular Aphasics During the First Year Post-Stroke

Acronym: APHACOM

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Aug 28, 2019
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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