Cross-cultural Adaptation to the Spanish Population and Validation of the Community Balance & Mobility Scale (S-CB&M)
S-CB&M
S-CB&M
Sponsor study identifier
observational
100
1 country
1
Study Start
February 9, 2021
Actual (reported)Primary Completion
June 15, 2022
Actual (reported)Study Completion
August 30, 2022
Actual (reported)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. 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 30, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 12, 2021
Actual (reported)January 14, 2021
Actual (reported)February 9, 2021
Actual (reported)June 15, 2022
Actual (reported)August 30, 2022
Actual (reported)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.
2 months
Validity
To analyze the convergent validity, it will be applied on the first day of the week and before receiving treatment.
2 months
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
2 months
Sensitivity to change
2 months
Spanish population with Acquired Brain Injury.
Cristina Lirio-Romero
Toledo, 45001, Spain
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.
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.
Cristina Lirio-Romero, PhD
University of Castilla-La Mancha
Marta Fernández-Hontoria, BsC
Centro de Referencia Estatal de Atención Al Daño Cerebral
100 participants (actual enrollment reported by the registry).
First Submitted
January 12, 2021
First Posted
January 14, 2021
Study Start
February 9, 2021
Actual (reported)Traumatic Brain Injury and the Gut Microbiome
Contact the study team to confirm eligibility.
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.
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.
Primary Completion
June 15, 2022
Actual (reported)Study Completion
August 30, 2022
Actual (reported)Last Updated
November 4, 2022
Record last verified: 2022-11
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