Italian Version of the Motricity Index

April 13, 2023 updated by: Fondazione Don Carlo Gnocchi Onlus

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

The Motricity Index (MI), developed by Demeurisse et al. in 1980, is an ordinal method for measuring motor impairment in post-stroke hemiparesis, focusing on muscle strength of proximal and distal muscle groups of upper and lower extremity. Since its introduction, it has been widely used. 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 MI-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 health professionals (physicians and physiotherapists) who 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 the professionals will be revised by the multidisciplinary translation team to produce the final MI-Italian.

The final MI-Italian will then be administered to a sample of at least 100 subjects with stroke to assess its metric properties. 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 MI-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 Barthel index, mBI; modified Rankin scale, mRS) to assess the validity of the MI-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 move and use the paretic limbs. 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 MI-Italian and the FMA, the mBI 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 ability to move and use the paretic limbs as an anchor.

Study Type

Observational

Enrollment (Anticipated)

115

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Internal Consistency - Baseline assessment
Time Frame: Assessment at admission (T0),
Cronbach's alpha
Assessment at admission (T0),
Internal Consistency - Discharge assessment
Time Frame: 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.
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
Time Frame: Test and Retest assessments, conducted 1-3 days apart.
One-way random-effects model sIngle measures Intraclass Correlation Coefficient (ICC1,1)
Test and Retest assessments, conducted 1-3 days apart.
Inter-rater reliability
Time Frame: Admission assessment conducted independently by two raters 30-60 minutes apart.
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)
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.
Test and Retest assessments, conducted 1-3 days apart.
Inter-rater reliability (error of measurement)
Time Frame: Admission assessment conducted independently by two 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.
Admission assessment conducted independently by two raters 30-60 minutes apart.
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.
Test and Retest assessments, conducted 1-3 days apart.
Inter-rater reliability (Minimal Detectable Change)
Time Frame: Admission assessment conducted independently by two 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.
Admission assessment conducted independently by two raters 30-60 minutes apart.
Criterion Validity - Association with reference standard at admission.
Time Frame: Admission assessment (T0).
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
Time Frame: 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.
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
Time Frame: Admission assessment (T0).
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.
Time Frame: 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.
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).
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 30 days from admission.
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)
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 30 days from admission.
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).
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 30 days from admission.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 15, 2023

Primary Completion (Anticipated)

December 15, 2023

Study Completion (Anticipated)

February 15, 2024

Study Registration Dates

First Submitted

February 3, 2023

First Submitted That Met QC Criteria

April 13, 2023

First Posted (Actual)

April 25, 2023

Study Record Updates

Last Update Posted (Actual)

April 25, 2023

Last Update Submitted That Met QC Criteria

April 13, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • mBI - MI - Part A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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