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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04070625
Other study ID # CHUBX 2008/10
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 17, 2009
Est. completion date February 10, 2012

Study information

Verified date August 2019
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date February 10, 2012
Est. primary completion date February 10, 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Communication book group
Communication book
Control group
Simple speech therapy

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Outcome

Type Measure Description Time frame Safety issue
Primary Number of successful tasks in the communication book Communication book of Gonzales et al, with 6 tasks At Day 45 after stroke
Primary Number of successful tasks in the communication book Communication book of Gonzales et al, with 6 tasks At Day 90 after stroke
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