Implementation of a Registry for Patients With Stroke

Stroke Clinical Trial

— STRATEGY  

Official title:

STroke RehabilitATion rEgistrY for Predicting Functional Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05389878
• Other study ID #: STRATEGY
• Status: Recruiting
• Start date: January 12, 2022
• Est. completion date: January 12, 2025

Study information

• Verified date: May 2022
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: Francesca Cecchi, MD
• Phone: +393388627184
• Email: fcecchi[@]dongnocchi.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: January 12, 2025
• Est. primary completion date: January 12, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
Italy	IRCCS Fondazione Don Carlo Gnocchi	Florence
Italy	IRCCS Fondazione Don Carlo Gnocchi Santa Maria Rinascente	Milan
Italy	Fondazione Don Gnocchi, Centro Santa Maria ai Servi	Parma
Italy	Fondazione Don Carlo Gnocchi Centro "Spalenza"	Rovato

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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 — View Citation

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, P — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	Change in Trunk Control Test	measure of trunk control range 0 worst- 100 best	Admission, discharge (average 30 days from admission)
Secondary	Change in Short Physical Performance Battery	measure of lower limbs physical performance range 0 worst-12 best	Admission, discharge (average 30 days from admission)
Secondary	Change in Motricity Index	Measure of motricity in upper and lower limb range 0 worst-100 best	Admission, discharge (average 30 days from admission)
Secondary	Change in Modified Ashworth Scale	Measure of upper and lower limb spasticity range range 0 best 100	Admission, discharge (average 30 days from admission)
Secondary	Change of Mini Mental State Examination	Cogntive level, range from 0 worst - 30 best	Admission, discharge (average 30 days from admission)