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Pathology registers are scientific research tools for the development of epidemiological and clinical studies and health planning, which allows access to useful elements for planning adequate health services. The Registry collects demographic, clinical and functional data of stroke patients and arises from the need to order and update this information for epidemiological and research purposes, for a better knowledge of this pathology from a rehabilitation point of view and to accelerate the development of new treatments.
The Italian Society of Physical and Rehabilitation Medicine has published a minimal assessment protocol for stroke patients1 (PMIC2020) to share the evaluation of stroke rehabilitation needs and outcomes at any time of the rehabilitation pathway, as grounds for a National Stroke Rehabilitation Registry (SRR).
The STRATEGY multicentric study aims to verify the feasibility of implementing a PMIC2020-based SRR in a routine clinical setting, and develop data-driven prognosis prediction models.
Demographic, functional and clinical variables will be collected at the admission and the discharge of the patient; in addition, two telephone follow-ups (three months and six months from the event) will be carried out
The study will involve several rehabilitation centers of the Don Gnocchi Foundation, Italy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stroke group | Patients with stroke addressing intensive inpatient rehabilitation, including and treatment, delivered according to an Individual Rehabilitation Project (IRP), defined according AHA ASA Stroke rehabilitation Guidelines (2016. The IRP was defined by an interdisciplinary team, coordinated by a physiatrist and designed according to patients' and caregivers' needs. The team included internists, physiotherapists, occupational therapists, nurses, speech therapists, and psychologists. The assessment protocol aimed to provide a reliable and synthetic assessment of patients' clinical conditions and function at admission and discharge. Each patient received at least three hours of specific rehabilitation per day. All patients received clinical observation and management, nurse management, physiotherapy. Speech, neuropsychological, and occupational therapy treatment were prescribed by physiatrist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rehabilitation | Other | All patients addressing intemsive inpatient post stroke rehabilitation undergo a shared evidence based Integrated Care pathway that is routinely adopted in all the participating Centres |
| Measure | Description | Time Frame |
|---|---|---|
| Change in modified Barthel Index | measure of ability in activity of daily living range 0 worst- 100 best | Admission, discharge (average 30 days from admission), follow-up (6 months after stroke) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in modified Rankin Score | measure of global disability range 0 best-5 worst | Admission, discharge (average 30 days from admission), follow-up (6 months after stroke) |
| Change in Functional Ambulation Category |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with stroke consecutively admitted in the centers involved
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesca Cecchi, MD | Contact | +393388627184 | fcecchi@dongnocchi.it |
| Name | Affiliation | Role |
|---|---|---|
| Francesca Cecchi, MD | IRCCS Fondazione don Carlo Gnocchi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Fondazione Don Carlo Gnocchi | Recruiting | Florence | 50143 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34042407 | Result | Cecchi F, Cassio A, Lavezzi S, Scarponi F, Gatta G, Montis A, Bernucci C, Franceschini M, Bargellesi S, Paolucci S, Taricco M. Redefining a minimal assessment protocol for stroke rehabilitation: the new "Protocollo di Minima per l'ICtus" (PMIC2020). Eur J Phys Rehabil Med. 2021 Oct;57(5):669-676. doi: 10.23736/S1973-9087.21.06638-7. Epub 2021 May 27. | |
| 33494558 |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| ID | Term |
|---|---|
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
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measure of functional ambulation range 0 worst- 6 best
| Admission, discharge (average 30 days from admission), follow-up (6 months after stroke) |
| Change in Trunk Control Test | measure of trunk control range 0 worst- 100 best | Admission, discharge (average 30 days from admission) |
| Change in Short Physical Performance Battery | measure of lower limbs physical performance range 0 worst-12 best | Admission, discharge (average 30 days from admission) |
| Change in Motricity Index | Measure of motricity in upper and lower limb range 0 worst-100 best | Admission, discharge (average 30 days from admission) |
| Change in Modified Ashworth Scale | Measure of upper and lower limb spasticity range range 0 best 100 | Admission, discharge (average 30 days from admission) |
| Change of Mini Mental State Examination | Cogntive level, range from 0 worst - 30 best | Admission, discharge (average 30 days from admission) |
| IRCCS Fondazione Don Carlo Gnocchi Santa Maria Rinascente | Not yet recruiting | Milan | Italy |
|
| Fondazione Don Gnocchi, Centro Santa Maria ai Servi | Not yet recruiting | Parma | Italy |
|
| Fondazione Don Carlo Gnocchi Centro "Spalenza" | Not yet recruiting | Rovato | Italy |
|
| Cecchi F, Diverio M, Arienti C, Corbella E, Marrazzo F, Speranza G, Del Zotto E, Poggianti G, Gigliotti F, Polcaro P, Zingoni M, Antonioli D, Avila L, Barilli M, Romano E, Landucci Pellegrini L, Gambini M, Verdesca S, Bertolucci F, Mosca I, Gemignani P, Paperini A, Castagnoli C, Hochleitner I, Luisi ML, Lucidi G, Hakiki B, Gabrielli MA, Fruzzetti M, Bruzzi A, Bacci Bonotti E, Pancani S, Galeri S, Macchi C, Aprile I. Development and implementation of a stroke rehabilitation integrated care pathway in an Italian no profit institution: an observational study. Eur J Phys Rehabil Med. 2020 Dec;56(6):713-724. doi: 10.23736/S1973-9087.20.06195-X. |
| 40341247 | Derived | Campagnini S, Sodero A, Baccini M, Hakiki B, Grippo A, Macchi C, Mannini A, Cecchi F. Prediction of the functional outcome of intensive inpatient rehabilitation after stroke using machine learning methods. Sci Rep. 2025 May 8;15(1):16083. doi: 10.1038/s41598-025-00781-1. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |