Implementation of a Registry for Patients With Stroke

Study Overview
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Brief Summary
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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
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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

Official Title
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STroke RehabilitATion rEgistrY for Predicting Functional Outcomes

Conditions
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Stroke

Intervention / Treatment
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* Other: rehabilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stroke group<br>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<br>* 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<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Registry, Outcome, Predictors