Italian Version of the Motricity Index

NCT05828160 | Unknown

• 1 other identifier: mBI - MI - Part A
• Study Type: observational
• Target: 115
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

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

  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.

• 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)

  Admission assessment conducted independently by two 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.

  Admission assessment conducted independently by two 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.

  Admission assessment conducted independently by two raters 30-60 minutes apart.

• 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).

• 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.

• 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).

• 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.

• 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.

• 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.

• 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A) In the pilot-testing, the pre-final MI-Italian will be tested for clarity on a sample of 10 health professionals (physicians and physiotherapists) working in stroke rehabilitation. B) The metric properties of the final MI-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:

• 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

You may not qualify if:

• 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.
• 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)
• 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.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Related Publications (13)

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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.

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  PMID: 10763800 BACKGROUND

• Collin C, Wade D. Assessing motor impairment after stroke: a pilot reliability study. J Neurol Neurosurg Psychiatry. 1990 Jul;53(7):576-9. doi: 10.1136/jnnp.53.7.576.

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  PMID: 7439211 BACKGROUND

• 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.

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• 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.

  PMID: 24582618 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 35094664 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

• Sunderland A, Tinson D, Bradley L, Hewer RL. Arm function after stroke. An evaluation of grip strength as a measure of recovery and a prognostic indicator. J Neurol Neurosurg Psychiatry. 1989 Nov;52(11):1267-72. doi: 10.1136/jnnp.52.11.1267.

  PMID: 2592969 BACKGROUND

• Vos-Vromans DC, de Bie RA, Erdmann PG, van Meeteren NL. The responsiveness of the ten-meter walking test and other measures in patients with hemiparesis in the acute phase. Physiother Theory Pract. 2005 Jul-Sep;21(3):173-80. doi: 10.1080/09593980500212920.

  PMID: 16389698 BACKGROUND

• Wade DT, Hewer RL. Functional abilities after stroke: measurement, natural history and prognosis. J Neurol Neurosurg Psychiatry. 1987 Feb;50(2):177-82. doi: 10.1136/jnnp.50.2.177.

  PMID: 3572432 BACKGROUND

Central Study Contacts

Marco Baccini, MSc

CONTACT

00393355911183; mbaccini@dongnocchi.it

Diego Longo, PhD

CONTACT

00393337664031; diego.longo@unifi.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 25, 2023
• Study Start: May 15, 2023
• Primary Completion: December 15, 2023
• Study Completion: February 15, 2024
• Last Updated: April 25, 2023

Record last verified: 2023-01