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Implementation of a Registry for Patients with Stroke

STroke RehabilitATion REgistrY for Predicting Functional Outcomes

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05389878
Acronym
STRATEGY
Enrollment
600
Registered
2022-05-25
Start date
2022-01-12
Completion date
2026-06-30
Last updated
2025-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Registry, Outcome, Predictors

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.

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

OTHERrehabilitation

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

Sponsors

Fondazione Don Carlo Gnocchi Onlus
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in modified Barthel IndexAdmission, 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

Secondary

MeasureTime frameDescription
Change in Functional Ambulation CategoryAdmission, discharge (average 30 days from admission), follow-up (6 months after stroke)measure of functional ambulation range 0 worst- 6 best
Change in Trunk Control TestAdmission, discharge (average 30 days from admission)measure of trunk control range 0 worst- 100 best
Change in Short Physical Performance BatteryAdmission, discharge (average 30 days from admission)measure of lower limbs physical performance range 0 worst-12 best
Change in modified Rankin ScoreAdmission, discharge (average 30 days from admission), follow-up (6 months after stroke)measure of global disability range 0 best-5 worst
Change in Modified Ashworth ScaleAdmission, discharge (average 30 days from admission)Measure of upper and lower limb spasticity range range 0 best 100
Change of Mini Mental State ExaminationAdmission, discharge (average 30 days from admission)Cogntive level, range from 0 worst - 30 best
Change in Motricity IndexAdmission, discharge (average 30 days from admission)Measure of motricity in upper and lower limb range 0 worst-100 best

Countries

Italy

Contacts

Primary ContactFrancesca Cecchi, MD
fcecchi@dongnocchi.it+393388627184

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026