Brain DamageBESTestNCT04052087
Cross-cultural Adaptation to the Spanish Population and Validation of the BESTest and Mini-BESTest
An observational study of Brain Damage, run by Centro de Referencia Estatal de Atención Al Daño Cerebral at 1 site in Spain.
Trial summary
Due to brain damage acquired (BDA), is often difficulty in gait and balance alterations, as problems that patients designated as the most disabling. It is essential to an effective assessment of the balance. Read more about this study
- Who is it for?
- Ages 16 to 54 years
- Conditions the study is for
- Brain Damage
- How many people
- 104 participants
- Where
- 1 siteSpain
- Study dates
- 15 Mar 2021to 30 Jun 2022
- How long will I take part?
- 2 Months
- Phase
- Observational
- 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 16 to 54 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Spanish population with Brain Damage Acquired.
Who may be able to join
- The participants will be all Ceadac's users.
- Adults who had suffered a BDA, at least 2 months before.
- The disability before suffering BDA was less than or equal to three on the scale modified Rankin.
- Lack of cognitive impairment scale Minimental State Examination, with a score is > 24.
- No previous diseases that alter the balance.
- Clinically stable and without fever-
- Ability to walk with technical support or without it.
- Signing an informed consent.
Who cannot join
- Medical contraindications to perform physical tests (acute or peripheral nervous system musculoskeletal disorders).
- Not understand the instructions.
- Subjects with severe aphasia.
- Subjects with acute processes of any added pathology.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cross-cultural Adaptation to the Spanish Population and Validation of the Test of Systems of Evaluation of Balance (BESTest) and Its Version Reduced in Persons With Acquired Brain Injury in Subacute and Chronic Phase
Due to brain damage acquired (BDA), is often difficulty in gait and balance alterations, as problems that patients designated as the most disabling. It is essential to an effective assessment of the balance.
Objective: The purpose of the present project adapt and verify the validity of the scale MiniBESTest, version of the BESTest, in patients with BDA in subacute and chronic stage, since that is postulated as a brief tool and covering the peculiarities of the specific alterations of the patient after suffering brain damage.
Read more
Methodology: Between September 2019 and December 2020 will be transcultural adaptation to the BDA and validation of psychometric scale Mini-BESTest in three phases. 60 subjects who receive treatment in the center of attention State reference to brain damage (CEADAC), together with the comunidad de Madrid private neurological rehabilitation centers will be recruited.
Results: validity and reliability parameters shall be calculated by means of descriptive statistics for each item of the scales and the set of scale score. You will also analyze the internal consistency using Cronbach's alpha, the interclass correlation coefficient will be used to determine the reliability, and the items will be scanned with the Pearson coefficient: > 0.20, among other parameters.
Read the detailed description
Marta Fernández Hontoria, physiotherapist at the State Reference Center of Attention to Brain Injury (CEADAC), will develop, together with her team formed by Cristina Lirio Romero and María Torres Lacomba of the Department of Physiotherapy at the University of Alcalá, a cross-cultural adaptation to the Spanish population with Adquired Brain Injury (ABI) and psychometric validation of the Mini-BESTest scale. Previously, the author of the scale has been asked for consent. The study will take place at the CEADAC. After receiving the approval of the Ethics and Clinical Research Committee of the University of Alcalá (Madrid), it is proposed to implement the study between September 2019 and May 2020. A minimum of 100 adults, aged between 18 and 65, will be recruited subacute or chronic state after suffering brain damage. The sample size conforms to COSMIN recommendations.
After verifying that there are no parallel studies on the subject in progress, the possible participants will be informed of the development of the investigation (ANNEX 1), who must sign the informed consent (ANNEX 2) before being recruited into the study. In addition, a coding sheet (ANNEX 3) of the participants will be filled in so that from now on the data related to the proper name does not appear but with a number that ensures the protection of their data.
The participants will be all users of CEADAC and the selection criteria to enter to participate in the study will be: adults who had suffered a ABI at least 2 months ago, that their disability before suffering it was less than or equal to three on the scale modified by Rankin, who have an absence of cognitive impairment according to the Minimental State Examination scale, that is, a score in it greater than 24, without previous diseases that alter the balance, that were clinically stable and without fever, with the ability to walk with help technical or without it, and that they gave their informed consent.
On the other hand, those people with medical contraindications for physical tests (acute musculoskeletal or peripheral nervous system disorders), who did not understand the instructions, severe aphasias or with subjects with acute processes of any added pathology will be excluded.
The study was developed in 3 phases:
Phase 1: Transcultural adaptation process. Phase 2: Pre-Test: collected , as well as the ease of interpretation of the results.
Phase 3: Psychometric validation process.
- Conditions
- Brain Damage
- Keywords
- Brain Damage Acquired, BDA in subacute and chronic stage, BESTest, Mini-BESTest, Balance, Postural control, Brain Stroke, Stroke, Cross-cultural adaptation
- Medical subject headings
- Brain Injuries, Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Test-retest Reliability
the overall consistency measures the homogeneity of the scale and the interdependence of the items, indicating the relationship between them.
To determine test-retest test reliability, the intraclass correlation coefficient (ICC) will be used. Derived from the test-retest reliability study, the measurement error will be calculated, using the formula ED (estandar deviation) x √1-ICC.
Measured: 2 months
Validity
To analyze the convergent validity, it will be applied on the first day of the week and before receiving treatment. Along with the scales to be evaluated, other balance scales will be administered.
Measured: 2 months
Secondary outcomes (1)
Sensitivity to change
Ability of the instrument to detect real changes in the health of the subjects, whether positive or negative.
The differences in the scores between the periods of the beginning of any proposed treatment and at the end of this will be evaluated by the effect size and the standardized response to the change.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start15 Mar 2021
- Primary completion20 Jan 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain DamageStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 104 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Centro de Referencia Estatal de Atención Al Daño Cerebral
- Sponsor type
- University, hospital or other
- Collaborators
- University of Castilla-La Mancha, University of Alcala
- Responsible party
- Principal investigator, MARTA FERNANDEZ HONTORIA, Centro de Referencia Estatal de Atención Al Daño Cerebral
- Investigators
- Cristina Lirio Romero, PhD, Study director, University of Castilla-La Mancha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04052087
- Sponsor's protocol ID
- Ceadac
- Acronym
- BESTest
- Status last verified
- Mar 2022
- First submitted
- 6 Aug 2019
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-cultural Adaptation to the Spanish Population and Validation of the Test of Systems of Evaluation of Balance (BESTest) and Its Version Reduced in Persons With Acquired Brain Injury in Subacute and Chronic Phase
- ClinicalTrials.gov ID
- NCT04052087
- Acronym / sponsor ID
- BESTest / Ceadac
- Conditions
- Brain Damage
- Keywords
- Brain Damage Acquired, BDA in subacute and chronic stage, BESTest, Mini-BESTest, Balance, Postural control, Brain Stroke, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Centro de Referencia Estatal de Atención Al Daño CerebralUniversity, hospital or other
- Collaborators
- University of Castilla-La Mancha, University of Alcala
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 9 Aug 2019 (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.
Due to brain damage acquired (BDA), is often difficulty in gait and balance alterations, as problems that patients designated as the most disabling. It is essential to an effective assessment of the balance.
Objective: The purpose of the present project adapt and verify the validity of the scale MiniBESTest, version of the BESTest, in patients with BDA in subacute and chronic stage, since that is postulated as a brief tool and covering the peculiarities of the specific alterations of the patient after suffering brain damage.
Methodology: Between September 2019 and December 2020 will be transcultural adaptation to the BDA and validation of psychometric scale Mini-BESTest in three phases. 60 subjects who receive treatment in the center of attention State reference to brain damage (CEADAC), together with the comunidad de Madrid private neurological rehabilitation centers will be recruited.
Results: validity and reliability parameters shall be calculated by means of descriptive statistics for each item of the scales and the set of scale score. You will also analyze the internal consistency using Cronbach's alpha, the interclass correlation coefficient will be used to determine the reliability, and the items will be scanned with the Pearson coefficient: > 0.20, among other parameters.
Detailed description
Marta Fernández Hontoria, physiotherapist at the State Reference Center of Attention to Brain Injury (CEADAC), will develop, together with her team formed by Cristina Lirio Romero and María Torres Lacomba of the Department of Physiotherapy at the University of Alcalá, a cross-cultural adaptation to the Spanish population with Adquired Brain Injury (ABI) and psychometric validation of the Mini-BESTest scale. Previously, the author of the scale has been asked for consent. The study will take place at the CEADAC. After receiving the approval of the Ethics and Clinical Research Committee of the University of Alcalá (Madrid), it is proposed to implement the study between September 2019 and May 2020. A minimum of 100 adults, aged between 18 and 65, will be recruited subacute or chronic state after suffering brain damage. The sample size conforms to COSMIN recommendations.
After verifying that there are no parallel studies on the subject in progress, the possible participants will be informed of the development of the investigation (ANNEX 1), who must sign the informed consent (ANNEX 2) before being recruited into the study. In addition, a coding sheet (ANNEX 3) of the participants will be filled in so that from now on the data related to the proper name does not appear but with a number that ensures the protection of their data.
The participants will be all users of CEADAC and the selection criteria to enter to participate in the study will be: adults who had suffered a ABI at least 2 months ago, that their disability before suffering it was less than or equal to three on the scale modified by Rankin, who have an absence of cognitive impairment according to the Minimental State Examination scale, that is, a score in it greater than 24, without previous diseases that alter the balance, that were clinically stable and without fever, with the ability to walk with help technical or without it, and that they gave their informed consent.
On the other hand, those people with medical contraindications for physical tests (acute musculoskeletal or peripheral nervous system disorders), who did not understand the instructions, severe aphasias or with subjects with acute processes of any added pathology will be excluded.
The study was developed in 3 phases:
Phase 1: Transcultural adaptation process. Phase 2: Pre-Test: collected , as well as the ease of interpretation of the results.
Phase 3: Psychometric validation process.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 2 Months
Who may qualify
- Ages
- 16 to 54 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Spanish population with Brain Damage Acquired.
Key inclusion criteria (8 listed)
- The participants will be all Ceadac's users.
- Adults who had suffered a BDA, at least 2 months before.
- The disability before suffering BDA was less than or equal to three on the scale modified Rankin.
- Lack of cognitive impairment scale Minimental State Examination, with a score is > 24.
- No previous diseases that alter the balance.
Key exclusion criteria (4 listed)
- Medical contraindications to perform physical tests (acute or peripheral nervous system musculoskeletal disorders).
- Not understand the instructions.
- Subjects with severe aphasia.
- Subjects with acute processes of any added pathology.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Test-retest Reliability
Time frame: 2 months
the overall consistency measures the homogeneity of the scale and the interdependence of the items, indicating the relationship between them. To determine test-retest test reliability, the intraclass correlation coefficient (ICC) will be used. Derived from the test-retest reliability study, the measurement error will be calculated, using the formula ED (estandar deviation) x √1-ICC.
Validity
Time frame: 2 months
To analyze the convergent validity, it will be applied on the first day of the week and before receiving treatment. Along with the scales to be evaluated, other balance scales will be administered.
1 secondary outcome
Sensitivity to change
Time frame: 2 months
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 27 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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.
Cristina Lirio Romero, PhD study director
University of Castilla-La Mancha
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Damage, run by Centro de Referencia Estatal de Atención Al Daño Cerebral 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 8 inclusion and 4 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 27 Jul 2022. 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?
Test-retest Reliability (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2022.