Implementation of a Registry for Patients With Stroke (STRATEGY)

STroke RehabilitATion rEgistrY for Predicting Functional Outcomes

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: rehabilitation

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

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Francesca Cecchi, MD; Phone Number: +393388627184; Email: fcecchi@dongnocchi.it

Study Locations

• Italy
  • Florence, Italy, 50143
    • Recruiting
    • IRCCS Fondazione Don Carlo Gnocchi
    • Contact: Francesca Cecchi, MD; Email: fcecchi@dongnocchi.it
  • Milan, Italy
    • Not yet recruiting
    • IRCCS Fondazione Don Carlo Gnocchi Santa Maria Rinascente
    • Contact: Mariangela Bianco, MD; Email: mbianco@dongnocchi.it
  • Parma, Italy
    • Not yet recruiting
    • Fondazione Don Gnocchi, Centro Santa Maria ai Servi
    • Contact: Lucia Falco, MD; Email: lfalco@dongnocchi.it
  • Rovato, Italy
    • Not yet recruiting
    • Fondazione Don Carlo Gnocchi Centro "Spalenza"
    • Contact: Silvia Galeri, MD; Email: sgaleri@dongnocchi.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with stroke consecutively admitted in the centers involved

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Fondazione Don Carlo Gnocchi Onlus
• Investigators: Principal Investigator: Francesca Cecchi, MD, IRCCS Fondazione Don Carlo Gnocchi

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2022
• Primary Completion (Anticipated): January 12, 2025
• Study Completion (Anticipated): January 12, 2025

Study Registration Dates

• First Submitted: February 23, 2022
• First Submitted That Met QC Criteria: May 21, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Actual): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 21, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Registry; Outcome; Predictors
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: STRATEGY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO