Italian Version of the Modified Barthel Index

NCT05831215 | Unknown

• 1 other identifier: mBI - MI - part B
• Study Type: observational
• Target: 145
• Locations: 0 countries
• Sites: N/A

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

Conditions

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

Outcome Measures

Primary Outcomes (15)

• Internal Consistency - Baseline assessment

  Cronbach's alpha

  Assessment at admission (T0).

• Internal Consistency - Discharge assessment

  Cronbach's alpha

  Assessment at discharge (T1). Time of discharge will vary among participants, so a definite time point cannot be stated. On average, discharge is expected after about 30 days from admission.

• Intra-rater reliability

  One-way random-effects model sIngle measures Intraclass Correlation Coefficient (ICC1,1).

  Test and Retest assessments, conducted 1-3 days apart.

• Inter-rater reliability

  One-way random-effects model sIngle measures Intraclass Correlation Coefficient (ICC1,1).

  Assessment at admission conducted independently by two independent raters 30-60 minutes apart.

• Intra-rater reliability (error of measurement)

  Standard Error of the Measurements (SEM), computed as the standard deviation of the two measures collected by the same rater, multiplied by the square root of 1 minus ICC.

  Test and Retest assessments, conducted 1-3 days apart.

• Inter-rater reliability (error of measurement)

  Standard Error of the Measurements (SEM), computed as the standard deviation of the measures collected by two independent raters, multiplied by the square root of 1 minus ICC.

  Assessment at admission conducted independently by two independent raters 30-60 minutes apart.

• Intra-rater reliability (Minimal Detectable Change)

  Minimal Detectable Change at the 95 % confidence level (MDC 95), computed as the SEM multiplied by 1,96 multiplied by the square root of 2.

  Test and Retest assessments, conducted 1-3 days apart.

• Inter-rater reliability (Minimal Detectable Change)

  Minimal Detectable Change at the 95 % confidence level (MDC 95), computed as the SEM multiplied by 1,96 multiplied by the square root of 2.

  Assessment at admission conducted independently by two independent raters 30-60 minutes apart.

• Criterion Validity - Association with reference standard at admission.

  Estimation of the correlation between the mBI-Italian and the modified Rankin Scale (mRS).

  Assessment at admission (T0).

• Criterion validity - Association with reference standard at discharge.

  Estimation of the correlation between the mBI-Italian and the mRS.

  Assessment at discharge (T1). Time of discharge will vary among participants, so a definite time point cannot be stated. On average, discharge is expected after about 30 days from admission.

• Construct validity (hypothesis testing) - Association with sensorimotor impairment at admission.

  Estimation of the correlation between the mBI-Italian and the Fugl-Meyer Assessment (FMA) scale.

  Assessment at admission (T0).

• Construct validity (hypothesis testing) - Association with sensorimotor impairment at discharge.

  Estimation of the correlation between the mBI-Italian and the FMA scale.

  Assessment at discharge (T1). Time of discharge will vary among participants, so a definite time point cannot be stated. On average, discharge is expected after about 30 days from admission.

• Responsiveness (change of mBI scores from admission to discharge) - Standardized Response Mean (SRM).

  For each subject, the change score at the mBI-Italian will be calculated as the difference between T1 and T0 assessment. The SRM will be calculated as the ratio of observed change and the standard deviation reflecting the variability of the change scores, both in the whole sample and separately in groups with different outcome based on the Global Rating of Perceived Change (GRPC).

  Admission (T0) and Discharge (T1) assessment. Time of discharge will vary among participants, so a definite time point cannot be stated. On average, discharge is expected after about 30 days from admission.

• Responsiveness (change of mBI scores from admission to discharge) - Guyatt Responsiveness Index (GRI).

  For each subject, the change score at the mBI-Italian will be calculated as the difference between T1 and T0 assessment. The GRI will be calculated as the ratio of the mean change score difference between improved and stable patients and the standard deviation of the individual change scores in stable patients. Improved and stable patients will be detected based on the GRPC.

  Admission (T0) and Discharge (T1) assessment. Time of discharge will vary among participants, so a definite time point cannot be stated. On average, discharge is expected after about 30 days from admission.

• Responsiveness (change of mBI-Italian scores from admission to discharge) - Minimal Clinically Important Difference (MCID).

  For each subject, the change score at the mBI-Italian will be calculated as the difference between T1 and T0 assessment. The Receiving Operator Characteristic (ROC) curve approach will be used to estimate the minimal change score associated with clinically important change (i.e., the MCID), using the GRPC as an anchor.

  Admission (T0) and Discharge (T1) assessment. Time of discharge will vary among participants, so a definite time point cannot be stated. On average, discharge is expected after about 30 days from admission.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A) In the pilot-testing, the pre-final versione of the mBI-Italian will be tested for clarity on a sample of 10 health professionals (physicians and physiotherapists) working in stroke rehabilitation, 10 subjects who had a stroke and 10 caregivers. B) The metric properties of the final mBI-italian will be tested on a sample of at least 100 patients who had a stroke. Considering a possible dropout rate of 15 percent, 115 subjects are expected to be enrolled.

You may qualify if:

• 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,

You may not qualify if:

• 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:
• 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.
• age 18 years or older
• stroke outcomes such that they impact the person's
• ability to independently perform various basic activities of daily living

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Related Publications (5)

• 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.

  PMID: 11124735 BACKGROUND

• 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.

  PMID: 34042407 BACKGROUND

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

  PMID: 14258950 BACKGROUND

• 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.

  PMID: 2760661 BACKGROUND

• 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.

  PMID: 20874835 BACKGROUND

Central Study Contacts

Marco Baccini, MSc

CONTACT

00393355911183; mbaccini@dongnocchi.it

Stefano Doronzio, MSc

CONTACT

00393924685537; sdoronzio@dongnocchi.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: April 26, 2023
• Study Start: June 15, 2023
• Primary Completion: February 15, 2024
• Study Completion: April 15, 2024
• Last Updated: April 26, 2023

Record last verified: 2022-12