Disability Physical Clinical Trial
Official title:
Development and Validation of the Italian Version of Modified Barthel Index and of the Motricity Index Scales
This study aims to develop and validate the Italian version of the Motricity Index (MI-Italian), through the following steps: - translation of the MI into Italian, by using the forward-backward translation approach, to produce a pre-final MI-Italian - pre-pilot testing of the pre-final MI-Italian in a sample of ten health professionals (physicians and physiotherapists), who will be asked to judge the clarity of each item of the MI, including scoring instructions, to produce a final MI-Italian - evaluation of the metric properties (internal consistency, inter- and intra-rater reliability, validity and responsiveness) of the final MI-Italian in a sample of subjects admitted to the Don Gnocchi Foundation in Florence for rehabilitation after stroke.
Status | Not yet recruiting |
Enrollment | 115 |
Est. completion date | February 15, 2024 |
Est. primary completion date | December 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | The study is divided in two phases: A) pilot-testing of the pre-final MI-Italian, and B) verification of the metric properties (reliability, validity and responsiveness) of the final MI-Italian. A) Pilot-test of the pre-final MI-Italian (verification of clarity of all items) Inclusion criteria: - 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 Exclusion criteria: none. B) Study on the metric properties of the final MI-Italian Participants (subjects who had a stroke): all subject 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. Inclusion: - 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: - 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 MI-Italian Other examiners, also randomly drawn from the list of ten raters, will administer other clinical scales to participants to assess the validity of the MI-Italian. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Fondazione Don Carlo Gnocchi Onlus |
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Bertrand AM, Fournier K, Wick Brasey MG, Kaiser ML, Frischknecht R, Diserens K. Reliability of maximal grip strength measurements and grip strength recovery following a stroke. J Hand Ther. 2015 Oct-Dec;28(4):356-62; quiz 363. doi: 10.1016/j.jht.2015.04.004. Epub 2015 May 9. — View Citation
Cameron D, Bohannon RW. Criterion validity of lower extremity Motricity Index scores. Clin Rehabil. 2000 Apr;14(2):208-11. doi: 10.1191/026921500675786655. — View Citation
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Fayazi M, Dehkordi SN, Dadgoo M, Salehi M. Test-retest reliability of Motricity Index strength assessments for lower extremity in post stroke hemiparesis. Med J Islam Repub Iran. 2012 Feb;26(1):27-30. — View Citation
Gor-Garcia-Fogeda MD, Molina-Rueda F, Cuesta-Gomez A, Carratala-Tejada M, Alguacil-Diego IM, Miangolarra-Page JC. Scales to assess gross motor function in stroke patients: a systematic review. Arch Phys Med Rehabil. 2014 Jun;95(6):1174-83. doi: 10.1016/j.apmr.2014.02.013. Epub 2014 Feb 28. — View Citation
Jacob-Lloyd HA, Dunn OM, Brain ND, Lamb SE. Effective Measurement of the Functional Progress of Stroke Clients. British Journal of Occupational Therapy. 2005;68(6):253-259. doi:10.1177/030802260506800603
Lin C, Arevalo YA, Harvey RL, Prabhakaran S, Martin KD. The minimal clinically important difference of the motricity index score. Top Stroke Rehabil. 2023 Apr;30(3):298-303. doi: 10.1080/10749357.2022.2031532. Epub 2022 Jan 30. — View Citation
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. — View Citation
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Internal Consistency - Baseline assessment | Cronbach's alpha | Assessment at admission (T0), | |
Primary | Internal Consistency - Discharge assessment | Cronbach's alpha | Discharge (T1) assessment. Time of discharge will vary among participants, so a definite time point cannot be stated. On average, discharge is expected after 30 days from admission. | |
Primary | Intra-rater reliability | One-way random-effects model sIngle measures Intraclass Correlation Coefficient (ICC1,1) | Test and Retest assessments, conducted 1-3 days apart. | |
Primary | Inter-rater reliability | One-way random-effects model sIngle measures Intraclass Correlation Coefficient (ICC1,1) | Admission assessment conducted independently by two raters 30-60 minutes apart. | |
Primary | 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. | |
Primary | 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. | Admission assessment conducted independently by two raters 30-60 minutes apart. | |
Primary | 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. | |
Primary | 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. | Admission assessment conducted independently by two raters 30-60 minutes apart. | |
Primary | Criterion Validity - Association with reference standard at admission. | Estimation of the correlation between the MI-Italian and Motricity subsection of the Fugl Meyer Assessment (FMA) scale, separately for upper limb and lower limb. | Admission assessment (T0). | |
Primary | Criterion Validity - Association with reference standard at discharge | Estimation of the correlation between the MI-Italian and Motricity subsection of the Fugl Meyer Assessment (FMA) scale, separately for upper limb and lower limb. | Discharge (T1) assessment. Time of discharge will vary among participants, so a definite time point cannot be stated. On average, discharge is expected after 30 days from admission. | |
Primary | Construct validity (Hypothesis testing) - Association with function at admission | Estimation of the correlation between the total scores of the MI-Italian and the modified Barthel Index (mBI). | Admission assessment (T0). | |
Primary | Construct validity (Hypothesis testing) - Association with function at discharge. | Estimation of the correlation between the total scores of the MI-Italian and the modified Barthel Index (mBI). | Discharge (T1) assessment. Time of discharge will vary among participants, so a definite time point cannot be stated. On average, discharge is expected after 30 days from admission. | |
Primary | Responsiveness (change of MI-Italian scores from admission to discharge) - Standardized Response Mean (SRM). | For each subject, the change score at the MI-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 30 days from admission. | |
Primary | Responsiveness (change of MI-Italian scores from admission to discharge) - Guyatt Responsiveness Index (GRI) | For each subject, the change score at the MI-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 30 days from admission. | |
Primary | Responsiveness (change of MI-Italian scores from admission to discharge) - Minimal Clinically Important Difference (MCID). | For each subject, the change score at the MI-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 30 days from admission. |
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