Clinical trial NCT05389878: Implementation of a Registry for Patients with Stroke
Official title: STroke RehabilitATion REgistrY for Predicting Functional Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Keywords: Registry
Outcome
Predictors
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stroke consecutively admitted in the centers involved

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* Adult patients (over 18 years of age) with ischemic or haemorrhagic stroke, first event or with relapse, time to onset of stroke less than 6 months, signature of informed consent by the patient or family member.

Exclusion Criteria:

* Patients from Severe Acquired Brain Injuries units and / or with diseases that threaten the patient's life

Primary outcomes:
measure: Change in modified Barthel Index
timeFrame: Admission, discharge (average 30 days from admission), follow-up (6 months after stroke)
Secondary outcomes:
measure: Change in modified Rankin Score
timeFrame: Admission, discharge (average 30 days from admission), follow-up (6 months after stroke)
measure: Change in Functional Ambulation Category
timeFrame: Admission, discharge (average 30 days from admission), follow-up (6 months after stroke)
measure: Change in Trunk Control Test
timeFrame: Admission, discharge (average 30 days from admission)
measure: Change in Short Physical Performance Battery
timeFrame: Admission, discharge (average 30 days from admission)
measure: Change in Motricity Index
timeFrame: Admission, discharge (average 30 days from admission)
measure: Change in Modified Ashworth Scale
timeFrame: Admission, discharge (average 30 days from admission)
measure: Change of Mini Mental State Examination
timeFrame: Admission, discharge (average 30 days from admission)
Other outcomes:
Locations:
city: Florence
country: Italy
facility: IRCCS Fondazione Don Carlo Gnocchi
city: Milan
country: Italy
facility: IRCCS Fondazione Don Carlo Gnocchi Santa Maria Rinascente
city: Parma
country: Italy
facility: Fondazione Don Gnocchi, Centro Santa Maria ai Servi
city: Rovato
country: Italy
facility: Fondazione Don Carlo Gnocchi Centro "Spalenza"
Study officials:
affiliation: IRCCS Fondazione don Carlo Gnocchi
name: Francesca Cecchi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.