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Brain Injury, ChronicS-CB&MNCT04710147

Cross-cultural Adaptation to the Spanish Population and Validation of the Community Balance & Mobility Scale (S-CB&M)

An observational study of Brain Injury, Chronic, run by University of Castilla-La Mancha at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Due to acquired brain injury (ABI), 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 18 to 65 years
Conditions the study is for
Brain Injury, Chronic
How many people
100 participants
Where
1 siteSpain
Study dates
9 Feb 2021to 30 Aug 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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Spanish population with Acquired Brain Injury.

Who may be able to join

  • The participants will be users from centers of attention to brain injury.
  • Adults who had suffered a ABI, at least 2 months before.
  • The disability before suffering ABI 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.

Spain1 site

  • Cristina Lirio-Romero

    Toledo, 45001

Other trials in Spain

About this study

Official title: Cross-cultural Adaptation to the Spanish Population and Validation of Community Balance & Mobility Scale in Persons With Acquired Brain Injury in Subacute and Chronic Phase

Due to acquired brain injury (ABI), 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 Community Balance and Mobility (CB\&M), in patients with ABI 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 injury.

Read more

Methodology: Between February 2021 and June 2022 will be transcultural adaptation to the ABI population and validation of psychometric scale CB\&M in three phases. 100 subjects who receive treatment in centers of attention to brain injury in Spain 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. Investigators 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

Cristina Lirio-Romero et al., will develop a cross-cultural adaptation to the Spanish population with Acquired Brain Injury (ABI) and psychometric validation of the Community Balance and Mobility (CB\&M) scale. The author of the scale has consented the adaptation of the scale. The study will take place at several centers of attention to brain injury in Spain. 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 February 2021 and June 2022. A minimum of 100 adults, aged between 18 and 65, will be recruited subacute or chronic state after suffering brain injury. 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.

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.

Keywords
Acquired Brain Injury, Balance Assessment, Central Nervous System Diseases
Medical subject headings
Brain Injury, Chronic, Brain Injuries, Central Nervous System Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1. 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 standard deviation (SD) x √1-ICC.

    Measured: 2 months

  2. Validity

    To analyze the convergent validity, it will be applied on the first day of the week and before receiving treatment.

    Measured: 2 months

  3. Berg Balance Scale

    It evaluates deficiencies in balance in response to 14 points ranging from 0-worst balance to 4-best balance (total 56 points). Berg Balance Scale is the gold standard of comparison for obtaining validity

    Measured: 2 months

Secondary outcomes (1)

  1. Sensitivity to change

    Ability of Community Balance and Movility to detect real changes in the health of the subjects, whether positive or negative (from 0-worse to 96-better balance and mobility).

    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.

  1. First posted14 Jan 2021
  2. Study start9 Feb 2021
  3. Primary completion15 Jun 2022
  4. Study completion30 Aug 2022

Resources

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
100 participants (actual)
Target duration
2 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04710147
Sponsor's protocol ID
CLirio05
Acronym
S-CB&M
Status last verified
Nov 2022
First submitted
12 Jan 2021
Last updated
4 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Perennou D, Decavel P, Manckoundia P, Penven Y, Mourey F, Launay F, Pfitzenmeyer P, Casillas JM. [Evaluation of balance in neurologic and geriatric disorders]. Ann Readapt Med Phys. 2005 Jul;48(6):317-35. doi: 10.1016/j.annrmp.2005.04.009. French.

    PubMed 15932776

  • Wild D, Grove A, Martin M, Eremenco S, McElroy S, Verjee-Lorenz A, Erikson P; ISPOR Task Force for Translation and Cultural Adaptation. Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health. 2005 Mar-Apr;8(2):94-104. doi: 10.1111/j.1524-4733.2005.04054.x.

    PubMed 15804318

  • Howe JA, Inness EL, Venturini A, Williams JI, Verrier MC. The Community Balance and Mobility Scale--a balance measure for individuals with traumatic brain injury. Clin Rehabil. 2006 Oct;20(10):885-95. doi: 10.1177/0269215506072183.

    PubMed 17008340

  • Inness EL, Howe JA, Niechwiej-Szwedo E, Jaglal SB, McIlroy WE, Verrier MC. Measuring Balance and Mobility after Traumatic Brain Injury: Validation of the Community Balance and Mobility Scale (CB&M). Physiother Can. 2011 Spring;63(2):199-208. doi: 10.3138/ptc.2009-45. Epub 2011 Apr 13.

    PubMed 22379260

Questions about this trial

What is this clinical trial studying?

An observational study of Brain Injury, Chronic, run by University of Castilla-La Mancha 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 4 Nov 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?

1. Test-retest Reliability (time frame: 2 months). The study lists 3 primary outcomes in all. 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 NCT04710147, which also lists 4 linked publications.

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 4 Nov 2022.

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