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Recruiting NCT05389878

Implementation of a Registry for Patients With Stroke

— Observational Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: rehabilitation.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

STroke RehabilitATion rEgistrY for Predicting Functional Outcomes

Overview

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

Interventions

  • Other 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

Primary outcome measures

  • Change in modified Barthel Index [Time frame: Admission, discharge (average 30 days from admission), follow-up (6 months after stroke)]
Secondary outcome measures (7)
  • Change in modified Rankin Score [Time frame: Admission, discharge (average 30 days from admission), follow-up (6 months after stroke)]
  • Change in Functional Ambulation Category [Time frame: Admission, discharge (average 30 days from admission), follow-up (6 months after stroke)]
  • Change in Trunk Control Test [Time frame: Admission, discharge (average 30 days from admission)]
  • Change in Short Physical Performance Battery [Time frame: Admission, discharge (average 30 days from admission)]
  • Change in Motricity Index [Time frame: Admission, discharge (average 30 days from admission)]
  • Change in Modified Ashworth Scale [Time frame: Admission, discharge (average 30 days from admission)]
  • Change of Mini Mental State Examination [Time frame: Admission, discharge (average 30 days from admission)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 4 centers
  • IRCCS Fondazione Don Carlo Gnocchi — Florence
  • IRCCS Fondazione Don Carlo Gnocchi Santa Maria Rinascente — Milan
  • Fondazione Don Gnocchi, Centro Santa Maria ai Servi — Parma
  • Fondazione Don Carlo Gnocchi Centro "Spalenza" — Rovato

Publications

  • 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
  • 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, PMID 33494558
  • 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

Identifiers

NCT: NCT05389878 · STRATEGY

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗