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

NCT04710147 | Completed

• 1 other identifier: CLirio05
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Brain Injury, Chronic

Keywords

Acquired Brain Injury; Balance Assessment; Central Nervous System Diseases

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (1)

• Sensitivity to change

  2 months

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Spanish population with Acquired Brain Injury.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Castilla-La Mancha: lead
• Centro de Referencia Estatal de Atención Al Daño Cerebral: collaborator

Study Sites (1)

Cristina Lirio-Romero

Toledo, 45001, Spain

Location

Related Publications (4)

• 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.

  PMID: 15932776 BACKGROUND

• 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.

  PMID: 15804318 BACKGROUND

• 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.

  PMID: 17008340 BACKGROUND

• 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.

  PMID: 22379260 BACKGROUND

MeSH Terms

Conditions

Brain Injury, Chronic; Brain Injuries; Central Nervous System Diseases

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Cristina Lirio-Romero, PhD

  University of Castilla-La Mancha

  PRINCIPAL INVESTIGATOR

• Marta Fernández-Hontoria, BsC

  Centro de Referencia Estatal de Atención Al Daño Cerebral

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 14, 2021
• Study Start: February 9, 2021
• Primary Completion: June 15, 2022
• Study Completion: August 30, 2022
• Last Updated: November 4, 2022

Record last verified: 2022-11

Locations

ES (1)