Cross-Cultural ComparisonNCT05831215
Italian Version of the Modified Barthel Index
An observational study of Cross-Cultural Comparison and Validation Study, run by Fondazione Don Carlo Gnocchi ETS.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cross-Cultural Comparison, Validation Study, Reliability and Validity
- How many people
- 145 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2023to 15 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 16Show fewer
- 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)
Who cannot join
- 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
Show all 17Show fewer
- 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.
- 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.
- 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
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Development and Validation of the Italian Version of the Modified Barthel Index and of the Motricity Index Scales
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
Read the 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Internal Consistency - Baseline assessment
Cronbach's alpha
Measured: Assessment at admission (T0).
Internal Consistency - Discharge assessment
Cronbach's alpha
Measured: 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).
Measured: Test and Retest assessments, conducted 1-3 days apart.
Inter-rater reliability
One-way random-effects model sIngle measures Intraclass Correlation Coefficient (ICC1,1).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Assessment at admission (T0).
Criterion validity - Association with reference standard at discharge.
Estimation of the correlation between the mBI-Italian and the mRS.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start15 Jun 2023 (estimated)
- Primary completion15 Feb 2024 (estimated)
- Study completion15 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cross-Cultural ComparisonStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05831215
- Sponsor's protocol ID
- mBI - MI - part B
- Status last verified
- Dec 2022
- First submitted
- 3 Feb 2023
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 11124735Cecchi 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.
PubMed 34042407MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.
PubMed 14258950Shah 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.
PubMed 2760661Sousa 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.
PubMed 20874835
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of the Italian Version of the Modified Barthel Index and of the Motricity Index Scales
- ClinicalTrials.gov ID
- NCT05831215
- Acronym / sponsor ID
- mBI - MI - part B
- Conditions
- Cross-Cultural Comparison, Validation Study, Reliability and Validity, Disability Physical
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 15 Jun 2023 (estimated)
- Primary completion
- 15 Feb 2024 (estimated)
- Study completion
- 15 Apr 2024 (estimated)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (16 listed)
- 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.
- age 18 years or older
- stroke outcomes such that they impact the person's ability to independently perform various basic activities of daily living
Key exclusion criteria (17 listed)
- Health professionals: none
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Internal Consistency - Baseline assessment
Time frame: Assessment at admission (T0).
Cronbach's alpha
Internal Consistency - Discharge assessment
Time frame: 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.
Cronbach's alpha
Intra-rater reliability
Time frame: Test and Retest assessments, conducted 1-3 days apart.
One-way random-effects model sIngle measures Intraclass Correlation Coefficient (ICC1,1).
Inter-rater reliability
Time frame: Assessment at admission conducted independently by two independent raters 30-60 minutes apart.
One-way random-effects model sIngle measures Intraclass Correlation Coefficient (ICC1,1).
Intra-rater reliability (error of measurement)
Time frame: Test and Retest assessments, conducted 1-3 days apart.
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.
Inter-rater reliability (error of measurement)
Time frame: Assessment at admission conducted independently by two independent raters 30-60 minutes apart.
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.
Intra-rater reliability (Minimal Detectable Change)
Time frame: Test and Retest assessments, conducted 1-3 days apart.
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.
Inter-rater reliability (Minimal Detectable Change)
Time frame: Assessment at admission conducted independently by two independent raters 30-60 minutes apart.
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.
Criterion Validity - Association with reference standard at admission.
Time frame: Assessment at admission (T0).
Estimation of the correlation between the mBI-Italian and the modified Rankin Scale (mRS).
Criterion validity - Association with reference standard at discharge.
Time frame: 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.
Estimation of the correlation between the mBI-Italian and the mRS.
Construct validity (hypothesis testing) - Association with sensorimotor impairment at admission.
Time frame: Assessment at admission (T0).
Estimation of the correlation between the mBI-Italian and the Fugl-Meyer Assessment (FMA) scale.
Construct validity (hypothesis testing) - Association with sensorimotor impairment at discharge.
Time frame: 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.
Estimation of the correlation between the mBI-Italian and the FMA scale.
Responsiveness (change of mBI scores from admission to discharge) - Standardized Response Mean (SRM).
Time frame: 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.
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).
Responsiveness (change of mBI scores from admission to discharge) - Guyatt Responsiveness Index (GRI).
Time frame: 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.
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.
Responsiveness (change of mBI-Italian scores from admission to discharge) - Minimal Clinically Important Difference (MCID).
Time frame: 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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Background: PubMed 11124735Beaton 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.
- Background: PubMed 34042407Cecchi 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.
- Background: PubMed 14258950MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.
- Background: PubMed 2760661Shah 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.
- Background: PubMed 20874835Sousa 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Cross-Cultural Comparison and Validation Study, run by Fondazione Don Carlo Gnocchi ETS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marco Baccini, MSc (00393355911183, mbaccini@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Internal Consistency - Baseline assessment (time frame: Assessment at admission (T0).). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05831215, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.