NCT05522530

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2022

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

August 31, 2022

Status Verified

August 1, 2022

Enrollment Period

1.3 years

First QC Date

August 28, 2022

Last Update Submit

August 28, 2022

Conditions

Vestibular DiseasePeripheral Vestibular Disorder

Outcome Measures

Primary Outcomes (1)

  • Mini BESTest

    Assessment scale of postural balance

    1 hour

Interventions

Assessment scaleOTHER

Evaluation scale to carry out its cross-cultural adaptation and study its validity

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People with peripheral vestibular disorders

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marcos Ceferino Gabriel Valdez

Almagro, Buenos Aires F.D., 1212, Argentina

Location

MeSH Terms

Conditions

Vestibular Diseases

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Therapist

Study Record Dates

First Submitted

August 28, 2022

First Posted

August 31, 2022

Study Start

January 10, 2021

Primary Completion

May 1, 2022

Study Completion

May 1, 2024

Last Updated

August 31, 2022

Record last verified: 2022-08

Locations

AR(1)