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Validation and Standardisation of a Pool of Simplified Evaluation Aimed to the Diagnoses of Aphasic Disorders and Adapted to the Patients Suffering an Acute Phase of Stroke (BESTA-AVC)

This study is currently recruiting participants.
Verified June 2016 by University Hospital, Limoges
Sponsor:
ClinicalTrials.gov Identifier:
NCT02548481
First Posted: September 14, 2015
Last Update Posted: August 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Limoges
  Purpose

Every year in France, from 100 000 to 145 000 people are affected by a stroke. 75% patients survived with aftereffects, in particular aphasic disorders.

A sketch of a new tool called BESTA aiming to a rapid handover to the acute phase post stroke had been worked out. After a meeting, 13 multidisciplinary experts have discussed, adjusted and a new complete tool (BESTA) had been created in order to evaluate the different states of aphasia.

The goal of this study is the validation and the standardization of this new BESTA tool.


Condition Intervention
Stroke Other: BESTA scale

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Validation and Standardisation of a Pool of Simplified Evaluation Aimed to the Diagnoses of Aphasic Disorders and Adapted to the Patients Suffering an Acute Phase of Stroke

Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • validity of concomitant criterion at T0 versus LAST [ Time Frame: 1 day ]

    T0: the gold standard was determined by the expert group is the LAST screening tool.

    The tool to be evaluated is the BESTA at T0. However, as written expression is not evaluated in the LAST, only the dimensions and Oral Expression Listening Comprehension of BESTA may actually be faced with LAST scale.



Estimated Enrollment: 395
Study Start Date: November 2015
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
BESTA scale
BESTA scale is administered at T0, T1 (3 months) and T2 (1 year)
Other: BESTA scale
BESTA scale is administrated at T0, T1 and T2.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Administration of BESTA scale (test to assess) within 3 days after stroke and at 3 months and 1 year after stroke. This scale will be compared to standard scales.
Criteria

Inclusion Criteria:

Patients with stroke:

  • Every patient over 18,
  • admitted among neuro-vascular unit,
  • native french speaker,
  • the level of vigilance is satisfactory in order to allow a speech therapy test.

Healthy Volunteers:

  • Every volunteers over 18,
  • without any medical history of a stroke or any speech disorders,
  • native french speaker.

Exclusion Criteria:

Patients with stroke and Healthy Volunteers :

  • dementia disease
  • psychiatric condition
  • non-equipped deafness
  • pregnant woman
  • patient with medical histories of stroke
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02548481


Contacts
Contact: Amandine CHANAUD +33 555 05 88 01 amandine.chanaud@yahoo.fr

Locations
France
Limoges Hospital Recruiting
Limoges, France, 87 042
Contact: Francisco MACIAN, MD         
Sponsors and Collaborators
University Hospital, Limoges
Investigators
Principal Investigator: Francisco MACIAN, MD University Hospital, Limoges
  More Information

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT02548481     History of Changes
Other Study ID Numbers: I14004
First Submitted: September 9, 2015
First Posted: September 14, 2015
Last Update Posted: August 17, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases