StrokeNCT04673539
Spanish Version of the Brief-BESTest in Stroke Patients
An observational study of Stroke, run by University of Salamanca at 1 site in Spain.
Trial summary
The aim of this study is to adapt and validate the Spanish version of the Brief-BESTest in stroke patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Spanish version of the Brief-BESTest in stroke patients
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2021to 30 Jun 2023
- 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
- Adult, Older adult
Study population: Stroke patients
Who may be able to join
- Older than 18 years old
- Diagnosis of stroke
Who cannot join
- Cognitive impairment
- Physical disability that prevents them from completing the assessment
- No cooperation and communication problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adaptation and Validation of the Spanish Version of the Brief-BESTest in Stroke Patients
The aim of this study is to adapt and validate the Spanish version of the Brief-BESTest in stroke patients
Read the detailed description
Balance disorder is a major risk factor for falls. The population that has suffered a cerebrovascular accident (CVA) or stroke has balance disorders. Over the last few years the assessment of balance has taken on special importance, carrying out the development, adaptation and validation of various tools that assess it.
The Brief-BESTest has 6 items, it has demonstrated comparable reliability to the Mini-BESTest and potentially superior sensitivity. This version represents all dimensions based on the original BESTest theory.
The purpose is to adapt and validate the Spanish version of the Brief-BESTest in stroke patients in order to have a brief tool, appropriate to the clinical environment and to the characteristics and limitations of these patients.
- Conditions
- Stroke
- Being tested
- Spanish version of the Brief-BESTest in stroke patients
- Keywords
- Stroke, Validation Study, Postural Balance
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spanish version of the Brief-BESTest in stroke patientsDiagnostic test
Adaptation and validation of the Spanish version of the Brief-BESTest in stroke Patients
| Study group | Role | What they receive |
|---|---|---|
| Single group | Instrument validation in stroke patients Receives: Diagnostic Test: Spanish version of the Brief-BESTest in stroke patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
BESTest
Measured: Baseline
Mini-BESTest
Measured: Baseline
Berg Balance Test
Measured: Baseline
Time Up and Go Test
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start1 Oct 2021
- Primary completion30 Oct 2022
- Study completion30 Jun 2023
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.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inés Llamas-Ramos, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673539
- Sponsor's protocol ID
- NEUROUSAL01/2020
- Status last verified
- Nov 2023
- First submitted
- 9 Dec 2020
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation and Validation of the Spanish Version of the Brief-BESTest in Stroke Patients
- ClinicalTrials.gov ID
- NCT04673539
- Acronym / sponsor ID
- NEUROUSAL01/2020
- Conditions
- Stroke
- Keywords
- Stroke, Validation Study, Postural Balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 17 Dec 2020 (actual)
- 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.
The aim of this study is to adapt and validate the Spanish version of the Brief-BESTest in stroke patients
Detailed description
Balance disorder is a major risk factor for falls. The population that has suffered a cerebrovascular accident (CVA) or stroke has balance disorders. Over the last few years the assessment of balance has taken on special importance, carrying out the development, adaptation and validation of various tools that assess it.
The Brief-BESTest has 6 items, it has demonstrated comparable reliability to the Mini-BESTest and potentially superior sensitivity. This version represents all dimensions based on the original BESTest theory.
The purpose is to adapt and validate the Spanish version of the Brief-BESTest in stroke patients in order to have a brief tool, appropriate to the clinical environment and to the characteristics and limitations of these patients.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group | – | Diagnostic Test: Spanish version of the Brief-BESTest in stroke patientsInstrument validation in stroke patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Stroke patients
Key inclusion criteria (2 listed)
- Older than 18 years old
- Diagnosis of stroke
Key exclusion criteria (3 listed)
- Cognitive impairment
- Physical disability that prevents them from completing the assessment
- No cooperation and communication problems
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 |
|---|---|---|
| Spanish version of the Brief-BESTest in stroke patientsAdaptation and validation of the Spanish version of the Brief-BESTest in stroke Patients | Diagnostic test | Single group |
Primary outcome
BESTest
Time frame: Baseline
Mini-BESTest
Time frame: Baseline
Berg Balance Test
Time frame: Baseline
Time Up and Go Test
Time frame: Baseline
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 30 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 of Salamanca at 1 site in Spain.
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 2 inclusion and 3 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 30 Nov 2023. 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 Spain. 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?
BESTest (time frame: Baseline). The study lists 4 primary outcomes in all. 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 30 Nov 2023.