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)

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.

Study Overview

• Status: Unknown
• Conditions: Stroke
• Intervention / Treatment: Other: BESTA scale

• Study Type: Observational
• Enrollment (Anticipated): 395

Contacts and Locations

Study Locations

• France
  • Limoges, France, 87 042
    • Recruiting
    • Limoges Hospital
    • Contact: Francisco MACIAN, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Limoges
• Investigators: Principal Investigator: Francisco MACIAN, MD, University Hospital, Limoges

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: September 9, 2015
• First Submitted That Met QC Criteria: September 10, 2015
• First Posted (Estimate): September 14, 2015

Study Record Updates

• Last Update Posted (Actual): June 1, 2020
• Last Update Submitted That Met QC Criteria: May 29, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: I14004