Italian Version of the Modified Barthel Index

NCT ID: NCT05831215

Last Updated: 2023-04-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 145 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-15
• Study Completion Date: 2024-04-15

Brief Summary

This study aims to develop and validate the Italian version of the modified Barthel Index (mBI-Italian), through the following steps:

• translation of the mBI into Italian, by using the froward-backward translation approach, to produce a pre-final mBI-Italian
• pre-pilot testing of the pre-final mBI-Italian in a sample of ten health professionals (physicians and physiotherapists), ten subjects who had a stroke, and 10 caregivers, i.e. subjects who take care of a person who had a stroke. All participants will be asked to judge the clarity of each item of the scale, including scoring instructions
• evaluation of the metric properties (internal consistency, inter- and intra-rater reliability, validity and responsiveness) of the final mBI-Italian in a sample of subjects admitted to the Don Gnocchi Foundation in Florence for rehabilitation after stroke

Detailed Description

The modified Barthel Index (mBI) (Shah et al (1989) is a worldwide adopted scale which investigates independence in the basic activities of daily living. It comprises ten items as the original version (personal hygiene, bathing, feeding, toilet, stairs, dressing, bowels, bladder, transfers, ambulation/wheelchair management), with a modification to the scoring to enhance its responsiveness. The mBI has been cross-culturally adapted in several countries and languages, However, despite unofficial versions circulating in clinical settings, there is currently no validated Italian version of the scale. This study aims to develop this version and to evaluate its metric properties in a sample of subjects who had a stroke.

A pre-final mBI-Italian will be produced following established international guidelines (forward-backward translation, each step involving two different translators). This version will be tested in a group of ten health professionals (physicians and physiotherapists), ten subjects who had a stroke and ten caregivers, All participants will be asked to judge the clarity of each item of the scale, including scoring instructions, using a dichotomous response (clear/unclear). Items that are judged unclear by more than 20 percent of evaluators will be revised by the multidisciplinary translation team to produce the final mBI-Italian.

The final mBI-Italian will then be administered to a sample of at least 100 subjects with stroke to assess its metric properties in this population. Participants will be enrolled among patients admitted to the Don Gnocchi Foundation in Florence for stroke rehabilitation. To assess reliability, upon admission each patient will be independently assessed using the mBI-Italian by two examiners, drawn at random from a group of ten physiotherapists. One of the two raters will administer the scale twice on consecutive days. Other evaluators will administer other clinical scales (Fugl-Meyer assessment, FMA; modified Rankin scale, mRS) to assess the validity of the mBI-Italian. All raters will be blinded to all other assessments and to their previous assessment, if any. All the scales will be administered again at discharge, when participants will also be asked to indicate the perceived change since admission in their ability to autonomously manage the basic activities of daily living (ADLs). For the latter, a 7-points Global Rating of Perceived Change (GRPC) Lickert scale will be used.

The Cronbach's alpha will be used to estimate the internal consistency of the scale. To assess intra-rater and inter-rater reliability, the Intraclass Correlation Coefficient (ICC1,1), Standard Error of the Measurement (SEM) and Minimal Detectable Change with 95% Confidence (MDC95) will be computed. Criterion and construct validity will be assessed by computing the association between the mBI-Italian and the FMA and the mRS, at both admission and discharge. For responsiveness, the following indices will be calculated: 1) Guyatt Responsiveness Index (GRI); 2) Standardized Response Mean (SMR), both in the whole sample and in subgroups of participants with different outcome (improved, unchanged, worsened) based on the GPRC; 3) Minimal Clinically Important Difference (MCID). The latter will be derived using the ROC curve approach, using the patient's perceived change in his/her autonomy in basic ADLs as an anchor.

Conditions

Cross-Cultural Comparison; Validation Study; Reliability and Validity; Disability Physical

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

Health professionals:

• Being a physician or a physiotherapist with at least three
• years of experience in the functional assessment of subjects with stroke;
• willingness to participate in the study.

Subjects who had a stroke:

• age 18 years or older
• stroke outcomes such that they impact the person's ability to independently perform various basic activities of daily living
• willingness to participate in the study, with informed consent signed (by the support administrator/legal guardian, if necessary)

Caregivers:

• age 18 years or older;
• Being a person who takes care of a disabled subject who had a stroke;
• willingness to participate in the study,

• age 18 years or older
• stroke outcomes such that they impact the person's
• ability to independently perform various basic activities of daily living
• willingness to participate in the study, with informed consent signed (by the support administrator/legal guardian, if necessary)

Exclusion Criteria

Health professionals: none

Subjects who had a stroke:

• severe visual and/or auditory impairment that cannot be corrected
• cognitive impairment defined by a Mini Mental State Examination (MMSE) score <21;
• severe language impairment such that comprehension and performance of the task is prevented
• presence of signs of clinical instability, defined by a score greater than zero on the Clinical Instability Scale

Caregivers:

• severe visual and/or auditory impairment that cannot be corrected
• cognitive impairment defined by a Mini Mental State Examination (MMSE) score <21
• severe language impairment such that comprehension and performance of the task is prevented.

B) Study on the metric properties of the final mBI-Italian:

1. Participants (subjects who had a stroke): all patients consecutively admitted to the Don Gnocchi Foundation of Florence for rehabilitation after stroke (until the expected sample size is completed) who meet the following criteria.

• severe visual and/or auditory impairment that cannot be corrected
• cognitive impairment defined by a Mini Mental State Examination (MMSE) score <21
• severe language impairment such that comprehension and performance of the task is prevented
• presence of signs of clinical instability, defined by a score greater than zero on the Clinical Instability Scale

2. Raters: ten physiotherapists with at least three years of experience in the evaluation and treatment of subjects with stroke outcomes. Pairs of raters, equal in number to the number of patients enrolled, will be randomly drawn from this group, and each pair will be randomly assigned to a patient to be administered the mBI-IT. Other examiners, also randomly drawn from the list of ten raters, will administer other clinical scales to participants to assess the validity of the mBI-IT.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Marco Baccini, MSc

Role: CONTACT

mbaccini@dongnocchi.it

00393355911183

Stefano Doronzio, MSc

Role: CONTACT

sdoronzio@dongnocchi.it

00393924685537

References

Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.

Reference Type: BACKGROUND

PMID: 11124735 (View on PubMed)

Cecchi F, Cassio A, Lavezzi S, Scarponi F, Gatta G, Montis A, Bernucci C, Franceschini M, Bargellesi S, Paolucci S, Taricco M. Redefining a minimal assessment protocol for stroke rehabilitation: the new "Protocollo di Minima per l'ICtus" (PMIC2020). Eur J Phys Rehabil Med. 2021 Oct;57(5):669-676. doi: 10.23736/S1973-9087.21.06638-7. Epub 2021 May 27.

Reference Type: BACKGROUND

PMID: 34042407 (View on PubMed)

MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.

Reference Type: BACKGROUND

PMID: 14258950 (View on PubMed)

Shah S, Vanclay F, Cooper B. Improving the sensitivity of the Barthel Index for stroke rehabilitation. J Clin Epidemiol. 1989;42(8):703-9. doi: 10.1016/0895-4356(89)90065-6.

Reference Type: BACKGROUND

PMID: 2760661 (View on PubMed)

Sousa VD, Rojjanasrirat W. Translation, adaptation and validation of instruments or scales for use in cross-cultural health care research: a clear and user-friendly guideline. J Eval Clin Pract. 2011 Apr;17(2):268-74. doi: 10.1111/j.1365-2753.2010.01434.x. Epub 2010 Sep 28.

Reference Type: BACKGROUND

PMID: 20874835 (View on PubMed)

Other Identifiers

mBI - MI - part B

Identifier Type: -

Identifier Source: org_study_id