Implementation of a Registry for Patients with Stroke

NCT05389878 | Recruiting

• 1 other identifier: STRATEGY
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 4

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.

Conditions

Stroke

Keywords

Registry; Outcome; Predictors

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (7)

• Change in modified Rankin Score

  Admission, discharge (average 30 days from admission), follow-up (6 months after stroke)

• Change in Functional Ambulation Category

  Admission, discharge (average 30 days from admission), follow-up (6 months after stroke)

• Change in Trunk Control Test

  Admission, discharge (average 30 days from admission)

• Change in Short Physical Performance Battery

  Admission, discharge (average 30 days from admission)

• Change in Motricity Index

  Admission, discharge (average 30 days from admission)

Study Arms (1)

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.

Other: rehabilitation

Interventions

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

Stroke group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with stroke consecutively admitted in the centers involved

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (4)

IRCCS Fondazione Don Carlo Gnocchi

Florence, 50143, Italy

RECRUITING

IRCCS Fondazione Don Carlo Gnocchi Santa Maria Rinascente

Milan, Italy

NOT YET RECRUITING

Fondazione Don Gnocchi, Centro Santa Maria ai Servi

Parma, Italy

NOT YET RECRUITING

Fondazione Don Carlo Gnocchi Centro "Spalenza"

Rovato, Italy

NOT YET RECRUITING

Related Publications (3)

• 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.

  PMID: 34042407 BACKGROUND

• 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.

  PMID: 33494558 BACKGROUND

• 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.

  PMID: 40341247 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Francesca Cecchi, MD

  IRCCS Fondazione don Carlo Gnocchi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesca Cecchi, MD

CONTACT

+393388627184; fcecchi@dongnocchi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: May 25, 2022
• Study Start: January 12, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4)