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

Brain Injury, Chronic Clinical Trial

— S-CB&M  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04710147
• Other study ID #: CLirio05
• Status: Completed
• Start date: February 9, 2021
• Est. completion date: August 30, 2022

Study information

• Verified date: November 2022
• Source: University of Castilla-La Mancha
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 30, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury, Chronic

Locations

Country	Name	City	State
Spain	Cristina Lirio-Romero	Toledo

Sponsors (2)

Lead Sponsor	Collaborator
University of Castilla-La Mancha	Centro de Referencia Estatal de Atención Al Daño Cerebral

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View Citation

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. — View Citation

Pérennou 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. Review. French. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 v1-ICC.	2 months
Primary	Validity	To analyze the convergent validity, it will be applied on the first day of the week and before receiving treatment.	2 months
Primary	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	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.	2 months