Cross-cultural Adaptation to the Spanish Population and Validation of the Community Balance & Mobility Scale (S-CB&M)
Condition: Brain Injury, Chronic
MeSH terms: Brain Injuries; Brain Injury, Chronic
Study type: Observational [Patient Registry]

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.
    

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.
    

Observational model: Other
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Spanish population with Acquired Brain Injury.
      
Keywords: Acquired Brain Injury; Balance Assessment; Central Nervous System Diseases