Implementation of a Registry for Patients with Stroke
- Conditions
- Stroke
- Interventions
- Other: rehabilitation
- Registration Number
- NCT05389878
- Lead Sponsor
- Fondazione Don Carlo Gnocchi Onlus
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
- 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.
- Patients from Severe Acquired Brain Injuries units and / or with diseases that threaten the patient's life
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Stroke group rehabilitation 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.
- Primary Outcome Measures
Name Time Method Change in modified Barthel Index 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
- Secondary Outcome Measures
Name Time Method Change in Short Physical Performance Battery Admission, discharge (average 30 days from admission) measure of lower limbs physical performance range 0 worst-12 best
Change in Motricity Index Admission, discharge (average 30 days from admission) Measure of motricity in upper and lower limb range 0 worst-100 best
Change in Modified Ashworth Scale Admission, discharge (average 30 days from admission) Measure of upper and lower limb spasticity range range 0 best 100
Change of Mini Mental State Examination Admission, discharge (average 30 days from admission) Cogntive level, range from 0 worst - 30 best
Change in modified Rankin Score Admission, discharge (average 30 days from admission), follow-up (6 months after stroke) measure of global disability range 0 best-5 worst
Change in Functional Ambulation Category Admission, 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 Test Admission, discharge (average 30 days from admission) measure of trunk control range 0 worst- 100 best
Trial Locations
- Locations (4)
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, Italy