StrokeSTRATEGYNCT05389878
Implementation of a Registry for Patients With Stroke
An observational study of Stroke, run by Fondazione Don Carlo Gnocchi ETS at 4 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- rehabilitation
- How many people
- 600 participants
- Where
- 4 sitesItaly
- Study dates
- 12 Jan 2022to 30 Jun 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stroke consecutively admitted in the centers involved
Who may be able to join
- 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.
Who cannot join
- Patients from Severe Acquired Brain Injuries units and / or with diseases that threaten the patient's life
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy4 sites, 4 recruiting
- Recruiting
IRCCS Fondazione Don Carlo Gnocchi
Florence, 50143
Francesca Cecchi, MD, fcecchi@dongnocchi.it
- Not yet recruiting
IRCCS Fondazione Don Carlo Gnocchi Santa Maria Rinascente
Milan
Mariangela Bianco, MD, mbianco@dongnocchi.it
- Not yet recruiting
Fondazione Don Gnocchi, Centro Santa Maria ai Servi
Parma
Lucia Falco, MD, lfalco@dongnocchi.it
- Not yet recruiting
Fondazione Don Carlo Gnocchi Centro "Spalenza"
Rovato
Silvia Galeri, MD, sgaleri@dongnocchi.it
About this study
Official title: 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.
Read the 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
- Being tested
- rehabilitation
- Keywords
- Registry, Outcome, Predictors
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rehabilitationOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in modified Barthel Index
measure of ability in activity of daily living range 0 worst- 100 best
Measured: Admission, discharge (average 30 days from admission), follow-up (6 months after stroke)
Secondary outcomes (7)
Change in modified Rankin Score
measure of global disability range 0 best-5 worst
Measured: 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
Measured: 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
Measured: Admission, discharge (average 30 days from admission)
Change in Short Physical Performance Battery
measure of lower limbs physical performance range 0 worst-12 best
Measured: Admission, discharge (average 30 days from admission)
Change in Motricity Index
Measure of motricity in upper and lower limb range 0 worst-100 best
Measured: Admission, discharge (average 30 days from admission)
Change in Modified Ashworth Scale
Measure of upper and lower limb spasticity range range 0 best 100
Measured: Admission, discharge (average 30 days from admission)
Change of Mini Mental State Examination
Cogntive level, range from 0 worst - 30 best
Measured: Admission, discharge (average 30 days from admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start12 Jan 2022
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesca Cecchi, Fondazione Don Carlo Gnocchi ETS
- Investigators
- Francesca Cecchi, MD, Principal investigator, IRCCS Fondazione don Carlo Gnocchi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05389878
- Sponsor's protocol ID
- STRATEGY
- Acronym
- STRATEGY
- Status last verified
- Mar 2025
- First submitted
- 23 Feb 2022
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 34042407Cecchi 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.
PubMed 33494558Campagnini 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.
PubMed 40341247
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STroke RehabilitATion rEgistrY for Predicting Functional Outcomes
- ClinicalTrials.gov ID
- NCT05389878
- Acronym / sponsor ID
- STRATEGY / STRATEGY
- Conditions
- Stroke
- Keywords
- Registry, Outcome, Predictors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke group | – | Other: rehabilitationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stroke consecutively admitted in the centers involved
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients from Severe Acquired Brain Injuries units and / or with diseases that threaten the patient's life
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rehabilitationAll patients addressing intemsive inpatient post stroke rehabilitation undergo a shared evidence based Integrated Care pathway that is routinely adopted in all the participating Centres | Other | Stroke group |
Primary outcome
Change in modified Barthel Index
Time frame: Admission, discharge (average 30 days from admission), follow-up (6 months after stroke)
measure of ability in activity of daily living range 0 worst- 100 best
7 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Results publication: PubMed 34042407Cecchi 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.
- Results publication: PubMed 33494558Cecchi 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.
- Derived from this study: PubMed 40341247Campagnini 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francesca Cecchi, MD principal investigator
IRCCS Fondazione don Carlo Gnocchi
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Fondazione Don Carlo Gnocchi ETS at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesca Cecchi, MD (+393388627184, fcecchi@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in modified Barthel Index (time frame: Admission, discharge (average 30 days from admission), follow-up (6 months after stroke)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05389878, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.