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Spanish Version of the Balance Evaluation Systems Test and Mini Balance Evaluation Systems Test (BESTest)

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ClinicalTrials.gov Identifier: NCT03403218
Recruitment Status : Completed
First Posted : January 18, 2018
Last Update Posted : January 18, 2018
Sponsor:
Collaborator:
Instituto Aragones de Ciencias de la Salud
Information provided by (Responsible Party):
Pilar Dominguez-Olivan, Universidad de Zaragoza

Brief Summary:
This study aim to translate the BESTest and mini-BESTest to Spanish, adapt it and investigate its validity in spanish population.

Condition or disease Intervention/treatment Phase
Balance Behavioral: Case group Not Applicable

Detailed Description:
To translate the BESTest and mini-BESTest to Spanish, adapt it and investigate its validity in spanish. Check its metric properties in relation to other balance tests.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Intervention Model Description: single group assignment. cross-sectional survey.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Translation and Validation of the Spanish Version of the BESTest and Mini-BESTest
Actual Study Start Date : September 18, 2017
Actual Primary Completion Date : November 16, 2017
Actual Study Completion Date : December 30, 2017

Arm Intervention/treatment
Experimental: case group
BESTest, mini-BESTest, Berg scale and FES (falls efficacy scale) (in Spanish version is administrated in case group.
Behavioral: Case group
assessment of quality on posture, transfers and displacement



Primary Outcome Measures :
  1. Concurrent validity of Best test- 1 [ Time Frame: 1 month ]
    concurrent validity of BESTest compare to other model balance tests


Secondary Outcome Measures :
  1. Psychometric properties of Spanish version of BESTest. [ Time Frame: 1 year ]
    To perform a detailed analysis of the psychometric properties of the BESTest Spanish version.

  2. Psychometric properties of Spanish version of mini-BESTest. [ Time Frame: 1 year ]
    To perform a detailed analysis of the psychometric properties of the mini-BESTest Spanish version.


Other Outcome Measures:
  1. concurrent validity of mini-BESTest [ Time Frame: 1 month ]
    concurrent validity of mini-BESTest compare to Berg scale and FES.



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Ages Eligible for Study:   65 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: healthy subjects without diagnosed balance problems.

Exclusion Criteria:

  • Diagnosed balance problems.
  • One falling in the last three months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03403218


Locations
Spain
Facultad de Ciencias de la Salud
Zaragoza, Spain, 50009
Sponsors and Collaborators
Universidad de Zaragoza
Instituto Aragones de Ciencias de la Salud
Investigators
Study Chair: Angel Mr Lanas-Arbeloa Instituto de Investigacion Sanitaria de Aragon
  Study Documents (Full-Text)

Documents provided by Pilar Dominguez-Olivan, Universidad de Zaragoza:
Statistical Analysis Plan  [PDF] September 23, 2017
Informed Consent Form  [PDF] September 23, 2017
Study Protocol  [PDF] January 9, 2018


Responsible Party: Pilar Dominguez-Olivan, PhD. Titular de Universidad., Universidad de Zaragoza
ClinicalTrials.gov Identifier: NCT03403218     History of Changes
Other Study ID Numbers: PI17/0282
First Posted: January 18, 2018    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Blind date analysis researcher. By coding affiliation information.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: data will become available from October 2017 and for three months.
Access Criteria: affiliation date are code. The rest of registration is shared.
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pilar Dominguez-Olivan, Universidad de Zaragoza:
balance, risk of falling