Cross-Cultural ComparisonNCT05828160
Italian Version of the Motricity 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 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cross-Cultural Comparison, Validation Study, Reliability and Validity
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2023to 15 Feb 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
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
- willingness to participate in the study, with informed consent signed (by the support administrator/legal guardian, if necessary)
Who cannot join
- 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.
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
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: 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)
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: 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.
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: 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.
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: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
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 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.
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 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.
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 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 posted25 Apr 2023
- Study start15 May 2023 (estimated)
- Primary completion15 Dec 2023 (estimated)
- Study completion15 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)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
- 115 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
- NCT05828160
- Sponsor's protocol ID
- mBI - MI - Part A
- Status last verified
- Jan 2023
- First submitted
- 3 Feb 2023
- Last updated
- 25 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 11124735Bertrand 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.
PubMed 26206167Cameron D, Bohannon RW. Criterion validity of lower extremity Motricity Index scores. Clin Rehabil. 2000 Apr;14(2):208-11. doi: 10.1191/026921500675786655.
PubMed 10763800Collin 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.
PubMed 2391521Demeurisse G, Demol O, Robaye E. Motor evaluation in vascular hemiplegia. Eur Neurol. 1980;19(6):382-9. doi: 10.1159/000115178.
PubMed 7439211Fayazi 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.
PubMed 23483112Gor-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.
PubMed 24582618Jacob-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.
PubMed 35094664Sousa 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 20874835Sunderland 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.
PubMed 2592969Vos-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.
PubMed 16389698Wade 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.
PubMed 3572432
Study at a glance
From the registry record, last updated by the sponsor on 25 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 Modified Barthel Index and of the Motricity Index Scales
- ClinicalTrials.gov ID
- NCT05828160
- Acronym / sponsor ID
- mBI - MI - Part A
- Conditions
- Cross-Cultural Comparison, Validation Study, Reliability and Validity, Disability Physical
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 15 May 2023 (estimated)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 15 Feb 2024 (estimated)
- First posted
- 25 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 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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 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
- willingness to participate in the study, with informed consent signed (by the support administrator/legal guardian, if necessary)
Key exclusion criteria (6 listed)
- 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.
- 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
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: 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
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: Admission assessment conducted independently by two 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: 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.
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: 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.
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.
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.
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).
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).
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).
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 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 26206167Bertrand 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.
- Background: PubMed 10763800Cameron D, Bohannon RW. Criterion validity of lower extremity Motricity Index scores. Clin Rehabil. 2000 Apr;14(2):208-11. doi: 10.1191/026921500675786655.
- Background: PubMed 2391521Collin 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.
- Background: PubMed 7439211Demeurisse G, Demol O, Robaye E. Motor evaluation in vascular hemiplegia. Eur Neurol. 1980;19(6):382-9. doi: 10.1159/000115178.
- Background: PubMed 23483112Fayazi 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.
- Background: PubMed 24582618Gor-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.
- BackgroundJacob-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: PubMed 35094664Lin 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.
- 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.
- Background: PubMed 2592969Sunderland 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.
- Background: PubMed 16389698Vos-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.
- Individual participant dataSharing planned: Undecided
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Food Hypersensitivity, Allergy
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 5 inclusion and 6 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 25 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 NCT05828160, which also lists 13 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 25 Apr 2023.