Implementation of a Registry for Patients with Stroke

NCT ID: NCT05389878

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-12
• Study Completion Date: 2026-06-30

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

Conditions

Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

rehabilitation

Intervention Type: 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

Interventions

rehabilitation

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role: lead

Responsible Party

Francesca Cecchi

Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francesca Cecchi, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Fondazione don Carlo Gnocchi

Locations

IRCCS Fondazione Don Carlo Gnocchi

Florence, , Italy

Site Status: RECRUITING

IRCCS Fondazione Don Carlo Gnocchi Santa Maria Rinascente

Milan, , Italy

Site Status: NOT_YET_RECRUITING

Fondazione Don Gnocchi, Centro Santa Maria ai Servi

Parma, , Italy

Site Status: NOT_YET_RECRUITING

Fondazione Don Carlo Gnocchi Centro "Spalenza"

Rovato, , Italy

Site Status: NOT_YET_RECRUITING

Countries

Italy

Central Contacts

Francesca Cecchi, MD

Role: CONTACT

fcecchi@dongnocchi.it

+393388627184

Facility Contacts

Francesca Cecchi, MD

Role: primary

fcecchi@dongnocchi.it

Mariangela Bianco, MD

Role: primary

mbianco@dongnocchi.it

Lucia Falco, MD

Role: primary

lfalco@dongnocchi.it

Silvia Galeri, MD

Role: primary

sgaleri@dongnocchi.it

References

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.

Reference Type: BACKGROUND

PMID: 34042407 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33494558 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40341247 (View on PubMed)

Other Identifiers

STRATEGY

Identifier Type: -

Identifier Source: org_study_id