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 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 12:19 AM
NCT ID:
NCT03530358
Eligibility Criteria:
Inclusion Criteria:
* diagnosis of first stroke;
* a score between 1 and 3 (included) at the upper limb sub-item on the Italian version of the National Institute of Health stroke scale (IT - NIHSS) (Pezzella et al., 2009)
* a score higher than 6 out of 66 on the Fugl - Meyer upper extremity (F-M UE) scale (Fugl-Meyer et al., 1975).
Exclusion Criteria:
* the presence of a moderate cognitive decline defined as a Mini Mental State Examination (Folstein et al., 1975) score \< 20/30 points;
* the finding of severe verbal comprehension deficit defined as a number of errors \> 13 (Tau Points \< 58/78) on the Token Test (Huber et al., 1984);
* evidence of apraxia and visuospatial neglect interfering with upper arm movements and manipulation of simple objects in all the directions within the visual field, as assessed through neurological examination;
* report in the patient's clinical history or evidence from the neurological examination of behavioural disturbances (i.e. delusions, aggressiveness and severe apathy/depression) that could affect compliance with the rehabilitation programs;
* non stabilised fractures;
* diagnosis of depression/delusion;
* associated traumatic brain injury;
* drug resistant epilepsy;
* evidence of ideomotor apraxia;
* evidence of visuospatial neglect;
* severe impairment of verbal comprehension defined as a score higher than 13 errors on Token test (i.e. score\<58 out of 78 Tau points).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03530358
Study Brief:
Protocol Section:
NCT03530358