Vestibular DiseaseNCT05522530
Cross-cultural Adaptation and Validity of Mini Bestest in Balance Disorders in the Autonomous City of Buenos Aires: Validation Study Protocol
An observational study of Vestibular Disease and Peripheral Vestibular Disorder, run by Hospital de Rehabilitacion Manuel Rocca at 1 site in Argentina.
Trial summary
The objective of this study is to carry out the cross-cultural adaptation of the Mini BESTest (a balance assessment scale) into Argentine Spanish, as well as to study its validation in patients with peripheral vestibular disorders in the autonomous city of Buenos Aires. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Vestibular Disease, Peripheral Vestibular Disorder
- What is being tested?
- Assessment scale
- How many people
- 100 participants
- Where
- 1 siteArgentina
- Study dates
- 10 Jan 2021to 1 May 2024
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with peripheral vestibular disorders
Who may be able to join
- Subjects >18 years of age,
- With vestibular alterations of peripheral etiology, within the second year of evolution
- Time of evolution of symptoms ≤ 2 years
- Independent walking with or without walking assistance device
- Who are at the beginning of a VR program
- No diagnoses of psychiatric disorders or cognitive impairment,
- Sign the informed consent
Who cannot join
- Who have suffered amputation in one of their lower limbs,
- History of neurological pathologies (stroke, multiple sclerosis, neuromuscular disease)
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Marcos Ceferino Gabriel Valdez
Almagro, Buenos Aires F.D., 1212
About this study
Official title: Cross-cultural Adaptation, Reliability, Validity and Viability of the Mini Bestest in Balance Disorders Upon Admission or Readmission to Vestibular Rehabilitation in the Autonomous City of Buenos Aires: Validation Study Protocol
The objective of this study is to carry out the cross-cultural adaptation of the Mini BESTest (a balance assessment scale) into Argentine Spanish, as well as to study its validation in patients with peripheral vestibular disorders in the autonomous city of Buenos Aires.
- Conditions
- Vestibular Disease, Peripheral Vestibular Disorder
- Being tested
- Assessment scale
- Medical subject headings
- Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment scaleOther
Evaluation scale to carry out its cross-cultural adaptation and study its validity
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini BESTest
Assessment scale of postural balance
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start10 Jan 2021
- Primary completion1 May 2022
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular DiseaseStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Rehabilitacion Manuel Rocca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcos Ceferino Gabriel Valdez, Hospital de Rehabilitacion Manuel Rocca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522530
- Sponsor's protocol ID
- 5884
- Status last verified
- Aug 2022
- First submitted
- 28 Aug 2022
- Last updated
- 31 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-cultural Adaptation, Reliability, Validity and Viability of the Mini Bestest in Balance Disorders Upon Admission or Readmission to Vestibular Rehabilitation in the Autonomous City of Buenos Aires: Validation Study Protocol
- ClinicalTrials.gov ID
- NCT05522530
- Acronym / sponsor ID
- 5884
- Conditions
- Vestibular Disease, Peripheral Vestibular Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital de Rehabilitacion Manuel RoccaUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 31 Aug 2022 (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 objective of this study is to carry out the cross-cultural adaptation of the Mini BESTest (a balance assessment scale) into Argentine Spanish, as well as to study its validation in patients with peripheral vestibular disorders in the autonomous city of Buenos Aires.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with peripheral vestibular disorders
Key inclusion criteria (7 listed)
- Subjects >18 years of age,
- With vestibular alterations of peripheral etiology, within the second year of evolution
- Time of evolution of symptoms ≤ 2 years
- Independent walking with or without walking assistance device
- Who are at the beginning of a VR program
Key exclusion criteria (2 listed)
- Who have suffered amputation in one of their lower limbs,
- History of neurological pathologies (stroke, multiple sclerosis, neuromuscular disease)
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 |
|---|---|---|
| Assessment scaleEvaluation scale to carry out its cross-cultural adaptation and study its validity | Other | – |
Primary outcome
Mini BESTest
Time frame: 1 hour
Assessment scale of postural balance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
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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 Vestibular Disease and Peripheral Vestibular Disorder, run by Hospital de Rehabilitacion Manuel Rocca at 1 site in Argentina.
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 7 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 31 Aug 2022. 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 Argentina. 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?
Results are not available in the source record.
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?
Mini BESTest (time frame: 1 hour). 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 31 Aug 2022.