Status:
UNKNOWN
Post-stroke Recovery (PSR_e2020)
Lead Sponsor:
Universita di Verona
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study presented is part of the departmental project entitled: BEHAVIORS AND WELLNESS: A MULTIDISCIPLINARY APPROACH TO PROMOTE THE QUALITY OF LIFE IN VULNERABILITY CONDITIONS - winner of the MIUR g...
Detailed Description
Cerebral stroke is the world's second leading cause of death with an incidence of 6.7 million deaths caused each year. Despite the progress made in the prevention and treatment of acute stroke, it rem...
Eligibility Criteria
Inclusion
- The population involved in work-package (WP) 1 will be the starting population from which to derive the population of the other WPs. As for WP 5, 6, 7, the population will follow that of WP1, while the involvement of patients in WP 2, 3, 4 will take place on the basis of further inclusion/exclusion criteria. This means that not all patients enrolled in WP1 will be involved in WP 2, 3, 4.
- WP 1, 5, 6, 7 Inclusion criteria
- Age over 18 years;
- First diagnosis of ischemic brain stroke (ICD9-CM 446, 434) documented radiologically (CT or MRI).
- Presence of post-stroke multidomain disability assessed with Fugl-Meyer assessment (FMA) and with Oxford Cognitive Screen (OCS).
- Patients in the sub-acute phase of cerebral stroke (\<3 months from the event) inpatients of the UOC Neurorehabilitation of the Integrated University Hospital of Verona for which the need to continue taking care of post-hospitalization rehabilitation was found.
- The ability of the subject and/or caregiver to understand the instructions provided for the self-management of home disability
- Signature of informed consent
- Exclusion criteria
- Contemporary participation in other clinical studies.
- Cognitive impairment defined as a score (corrected) for the Mini-Mental State Examination \<23.8.
- Substance abuse.
- Other neurological and orthopaedic pathologies capable of interfering with the study.
- Particularly vulnerable populations cannot be included in the study:
- patients with judicial interdiction
- patients for whom a legal guardian has been appointed
- institutionalized patients
- Criteria for exit from the study
- Relapse of disease during the study period
- Withdrawal of informed consent to participate in the study
- Impossibility to carry out the assessments foreseen by the study protocol or the rehabilitation treatment according to the defined schedule.
- Description of the pathologies studied Outcomes of cerebral stroke with ischemic aetiology (ICD9-CM 446, 434).
- WP2 criteria Inclusion criteria
- See inclusion criteria WP 1
- Presence of specific cognitive disorders as assessed by OCS
- Adequate comprehension skills as assessed through the OCS Semantic Test Exclusion criteria
- See exclusion criteria WP 1
- Limited sustained attention span as assessed during the neuropsychological assessment.
- WP3 criteria Inclusion criteria
- See inclusion criteria WP 1
- patients suffering from cerebral stroke outcomes in chronic phase (after 3 months from the acute event) or post-hospital discharge
- independent gait or by means of aids (eg cane)
- Adequate comprehension skills as assessed through the OCS Semantic Test Exclusion criteria
- See exclusion criteria WP 1
- WP4 criteria Inclusion criteria
- See inclusion criteria WP 1
- Presence of pain following a stroke assessed by Brief Pain Inventory -I
- Adequate understanding and production skills as assessed through OCS language tests Exclusion criteria
- See exclusion criteria WP 1
- Presence of moderate/severe cognitive disorders assessed by OCS which could compromise the insight and communication skills necessary to fill in specific psychological questionnaires.
Exclusion
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2024
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT04323501
Start Date
May 1 2021
End Date
June 30 2024
Last Update
May 23 2022
Active Locations (1)
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1
Section of Clinical Neurology, Department Neurological, Neuropsychological, Morphological and Movement Sciences, University of Verona, Verona, Italy
Verona, Italy, 37124