Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT05828160
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05828160
Study Brief:
Protocol Section:
NCT05828160