Cross-cultural Adaptation to the Spanish Population and Validation of the BESTest and Mini-BESTest

NCT04052087 | Completed

• 1 other identifier: Ceadac
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

Due to brain damage acquired (BDA), 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 MiniBESTest, version of the BESTest, in patients with BDA 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 damage. Methodology: Between September 2019 and December 2020 will be transcultural adaptation to the BDA and validation of psychometric scale Mini-BESTest in three phases. 60 subjects who receive treatment in the center of attention State reference to brain damage (CEADAC), together with the comunidad de Madrid private neurological rehabilitation centers 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. You 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 Damage

Keywords

Brain Damage Acquired; BDA in subacute and chronic stage; BESTest; Mini-BESTest; Balance; Postural control; Brain Stroke; Stroke; Cross-cultural adaptation

Outcome Measures

Primary Outcomes (2)

• 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 ED (estandar deviation) 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. Along with the scales to be evaluated, other balance scales will be administered.

  2 months

Secondary Outcomes (1)

• Sensitivity to change

  2 months

Eligibility Criteria

• Age: 16 Years - 54 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Spanish population with Brain Damage Acquired.

You may qualify if:

• The participants will be all Ceadac's users.
• Adults who had suffered a BDA, at least 2 months before.
• The disability before suffering BDA 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

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

Study Sites (1)

Ceadac

Madrid, 28034, Spain

Location

MeSH Terms

Conditions

Brain Injuries; Stroke

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Cristina Lirio Romero, PhD

  University of Castilla-La Mancha

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 9, 2019
• Study Start: March 15, 2021
• Primary Completion: January 20, 2022
• Study Completion: June 30, 2022
• Last Updated: July 27, 2022

Record last verified: 2022-03

Locations

ES (1)