BalanceBESTestNCT03403218
Spanish Version of the Balance Evaluation Systems Test and Mini Balance Evaluation Systems Test
A study testing Case group in people with Balance, run by Universidad de Zaragoza at 1 site in Spain.
Trial summary
This study aim to translate the BESTest and mini-BESTest to Spanish, adapt it and investigate its validity in spanish population. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Balance
- What is being tested?
- Case group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- 18 Sep 2017to 30 Dec 2017
- Phase
- Interventional
- 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 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
None listed.
Who cannot join
- Diagnosed balance problems.
- One falling in the last three months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Balance
- Being tested
- Case group
- Keywords
- balance, risk of falling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case groupBehavioural
assessment of quality on posture, transfers and displacement
| Study group | Role | What they receive |
|---|---|---|
| case group | Experimental | BESTest, mini-BESTest, Berg scale and FES (falls efficacy scale) (in Spanish version is administrated in case group. Receives: Behavioral: Case group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concurrent validity of Best test- 1
concurrent validity of BESTest compare to other model balance tests
Measured: 1 month
Secondary outcomes (2)
Psychometric properties of Spanish version of BESTest.
To perform a detailed analysis of the psychometric properties of the BESTest Spanish version.
Measured: 1 year
Psychometric properties of Spanish version of mini-BESTest.
To perform a detailed analysis of the psychometric properties of the mini-BESTest Spanish version.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start18 Sep 2017
- Primary completion16 Nov 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BalanceStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single group assignment. cross-sectional survey.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Zaragoza
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Aragones de Ciencias de la Salud
- Responsible party
- Principal investigator, Pilar Dominguez-Olivan, Universidad de Zaragoza
- Investigators
- Angel Mr Lanas-Arbeloa, Study chair, Instituto de Investigacion Sanitaria de Aragon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03403218
- Sponsor's protocol ID
- PI17/0282
- Acronym
- BESTest
- Status last verified
- Jan 2018
- First submitted
- 23 Sep 2017
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Blind date analysis researcher. By coding affiliation information.
Publications
Dominguez-Olivan P, Gasch-Gallen A, Aguas-Garcia E, Bengoetxea A. Validity and reliability testing of the Spanish version of the BESTest and mini-BESTest in healthy community-dwelling elderly. BMC Geriatr. 2020 Nov 4;20(1):444. doi: 10.1186/s12877-020-01724-3.
PubMed 33148216
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation and Validation of the Spanish Version of the BESTest and Mini-BESTest
- ClinicalTrials.gov ID
- NCT03403218
- Acronym / sponsor ID
- BESTest / PI17/0282
- Conditions
- Balance
- Keywords
- balance, risk of falling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Universidad de ZaragozaUniversity, hospital or other
- Collaborators
- Instituto Aragones de Ciencias de la Salud
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 16 Nov 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 18 Jan 2018 (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.
This study aim to translate the BESTest and mini-BESTest to Spanish, adapt it and investigate its validity in spanish population.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single group assignment. cross-sectional survey.
| Arm | Type | Receives |
|---|---|---|
| case group | Experimental | Behavioral: Case groupBESTest, mini-BESTest, Berg scale and FES (falls efficacy scale) (in Spanish version is administrated in case group. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Diagnosed balance problems.
- One falling in the last three months.
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 |
|---|---|---|
| Case groupassessment of quality on posture, transfers and displacement | Behavioural | case group |
Primary outcome
Concurrent validity of Best test- 1
Time frame: 1 month
concurrent validity of BESTest compare to other model balance tests
2 secondary outcomes
Psychometric properties of Spanish version of BESTest.
Time frame: 1 year
Psychometric properties of Spanish version of mini-BESTest.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
- Derived from this study: PubMed 33148216Dominguez-Olivan P, Gasch-Gallen A, Aguas-Garcia E, Bengoetxea A. Validity and reliability testing of the Spanish version of the BESTest and mini-BESTest in healthy community-dwelling elderly. BMC Geriatr. 2020 Nov 4;20(1):444. doi: 10.1186/s12877-020-01724-3.
- Individual participant dataSharing planned: Yes. Blind date analysis researcher. By coding affiliation information.
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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.
Angel Mr Lanas-Arbeloa study chair
Instituto de Investigacion Sanitaria de Aragon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Case group in people with Balance, run by Universidad de Zaragoza at 1 site in Spain.
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 0 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: finished, as of the sponsor's last update on 18 Jan 2018. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Concurrent validity of Best test- 1 (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03403218, which also lists 1 linked publication.
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 18 Jan 2018.