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

Stroke Clinical Trial

— BESTA-AVC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02548481
• Other study ID #: I14004
• Status: Recruiting
• Start date: November 2015
• Est. completion date: June 2021

Study information

• Verified date: March 2020
• Source: University Hospital, Limoges
• Contact: Amandine CHANAUD
• Phone: +33 555 05 88 01
• Email: amandine.chanaud[@]yahoo.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 395
• Est. completion date: June 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• BESTA scale
BESTA scale is administrated at T0, T1 and T2.

Locations

Country	Name	City	State
France	Limoges Hospital	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	validity of concomitant criterion at T0 versus LAST	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.	1 day