Cross-cultural Adaptation and Validity of Mini Bestest in Balance Disorders in the Autonomous City of Buenos Aires: Validation Study Protocol

August 28, 2022 updated by: Marcos Ceferino Gabriel Valdez, Hospital de Rehabilitacion Manuel Rocca

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Autonomous City Of Buenos Aires
      • Almagro, Autonomous City Of Buenos Aires, Argentina, 1212
        • Marcos Ceferino Gabriel Valdez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

People with peripheral vestibular disorders

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Who have suffered amputation in one of their lower limbs,
  • History of neurological pathologies (stroke, multiple sclerosis, neuromuscular disease)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mini BESTest
Time Frame: 1 hour
Assessment scale of postural balance
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Rehabilitacion Manuel Rocca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 10, 2021

Primary Completion (ACTUAL)

May 1, 2022

Study Completion (ANTICIPATED)

May 1, 2024

Study Registration Dates

First Submitted

August 28, 2022

First Submitted That Met QC Criteria

August 28, 2022

First Posted (ACTUAL)

August 31, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 31, 2022

Last Update Submitted That Met QC Criteria

August 28, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5884

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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