Communication Book in Pragmatic Communication in Vascular Aphasics (APHACOM)

August 26, 2019 updated by: University Hospital, Bordeaux

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

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 Overview

Status

Completed

Conditions

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

Observational

Enrollment (Actual)

34

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Pierre-Alain JOSEPH, Pr, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2009

Primary Completion (Actual)

February 10, 2012

Study Completion (Actual)

February 10, 2012

Study Registration Dates

First Submitted

August 26, 2019

First Submitted That Met QC Criteria

August 26, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 26, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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