StrokeBESTA-AVCNCT02548481
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
An observational study of Stroke, run by University Hospital, Limoges at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- BESTA scale
- How many people
- 395 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2015to Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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:
Show all 9Show fewer
- Every volunteers over 18,
- without any medical history of a stroke or any speech disorders,
- native french speaker.
Who cannot join
- Patients with stroke and Healthy Volunteers :
- dementia disease
- psychiatric condition
- non-equipped deafness
- pregnant woman
- patient with medical histories of stroke
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Stroke
- Being tested
- BESTA scale
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BESTA scaleOther
BESTA scale is administrated at T0, T1 and T2.
| Study group | Role | What they receive |
|---|---|---|
| BESTA scale | BESTA scale is administered at T0, T1 (3 months) and T2 (1 year) Receives: Other: BESTA scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2020
- Study completionJun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 395 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francisco MACIAN, MD, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02548481
- Sponsor's protocol ID
- I14004
- Acronym
- BESTA-AVC
- Status last verified
- Mar 2020
- First submitted
- 9 Sep 2015
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02548481
- Acronym / sponsor ID
- BESTA-AVC / I14004
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 395 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 14 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BESTA scale | – | Other: BESTA scaleBESTA scale is administered at T0, T1 (3 months) and T2 (1 year) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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.
- Every volunteers over 18,
Key exclusion criteria (6 listed)
- dementia disease
- psychiatric condition
- non-equipped deafness
- pregnant woman
- patient with medical histories of stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BESTA scaleBESTA scale is administrated at T0, T1 and T2. | Other | BESTA scale |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco MACIAN, MD principal investigator
University Hospital, Limoges
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
validity of concomitant criterion at T0 versus LAST (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.