- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03403218
Spanish Version of the Balance Evaluation Systems Test and Mini Balance Evaluation Systems Test (BESTest)
January 17, 2018 updated by: Pilar Dominguez-Olivan, Universidad de Zaragoza
Translation and Validation of the Spanish Version of the BESTest and Mini-BESTest
This study aim to translate the BESTest and mini-BESTest to Spanish, adapt it and investigate its validity in spanish population.
Study Overview
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
Enrollment (Actual)
12
Phase
- Not Applicable
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
-
-
-
Zaragoza, Spain, 50009
- Facultad de Ciencias de la Salud
-
-
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
65 years to 85 years (OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria: healthy subjects without diagnosed balance problems.
-
Exclusion Criteria:
- Diagnosed balance problems.
- One falling in the last three months.
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
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: case group
BESTest, mini-BESTest, Berg scale and FES (falls efficacy scale) (in Spanish version is administrated in case group.
|
assessment of quality on posture, transfers and displacement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Concurrent validity of Best test- 1
Time Frame: 1 month
|
concurrent validity of BESTest compare to other model balance tests
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 year
|
|
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.
|
1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
concurrent validity of mini-BESTest
Time Frame: 1 month
|
concurrent validity of mini-BESTest compare to Berg scale and FES.
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Angel Mr Lanas-Arbeloa, Instituto de Investigacion Sanitaria de Aragon
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
September 18, 2017
Primary Completion (Actual)
November 16, 2017
Study Completion (Actual)
December 30, 2017
Study Registration Dates
First Submitted
September 23, 2017
First Submitted That Met QC Criteria
January 17, 2018
First Posted (Actual)
January 18, 2018
Study Record Updates
Last Update Posted (Actual)
January 18, 2018
Last Update Submitted That Met QC Criteria
January 17, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PI17/0282
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Blind date analysis researcher.
By coding affiliation information.
IPD Sharing Time Frame
data will become available from October 2017 and for three months.
IPD Sharing Access Criteria
affiliation date are code.
The rest of registration is shared.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
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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