Post Stroke Intensive Rehabilitation

NCT ID: NCT03866057

Last Updated: 2019-05-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 270 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2020-12-31

Brief Summary

Prospective observational cohort study, with 6 months follow up, to identify clinical, instrumental and genetic predictors of functional recovery in hospitalized patients undergoing intensive rehabilitation after stroke. All patients will be evaluated with a standardized protocol. Functional recovery will be assessed at the discharge and after a period of 6 months.

Detailed Description

Despite progress in the treatment of cerebrovascular diseases in the acute phase, stroke remains a catastrophic event with important public health implications. Post-acute intensive rehabilitation is recommended in patients with neurological deficits, but standardized evaluation protocols are essential for evaluate the efficacy of rehabilitation and for the early identification of prognostic factors of recovery. The search for biomarkers of response to specific treatments aimed to customizing the intervention. Recent studies highlight the importance of neurophysiological markers as predictors of post-stroke epilepsy onset and prognosis. Also genetic substrate and epigenetic mechanisms have a prognostic role; the latter may be modified by the administration of Selective Serotonin Reuptake Inhibitor (SSRI) drugs, largely prescribed according to guidelines in post-stroke depression, confirming the neurotrophic role of these drugs postulated in many studies but never demonstrated in vivo in humans. Specific physiotherapeutic interventions also seem to stimulate optimal functional recovery and brain neuroplasticity, in particular those based on the intensive repetition of tasks, such as robotics and Mirror Therapy. Given that the mechanisms of neuronal plasticity activated by these interventions are presumably different, it is hypothesizable that there are specific predictors of response for each of them.

The primary endpoint of this study is to identify clinical, instrumental and genetic predictors of functional recovery in hospitalized patients undergoing intensive rehabilitation after stroke, evaluated with standardized protocol. Recovery will be assessed at discharge and at follow-up after 6 months.

Secondary endpoints are:

• evaluate the development of post-stroke epilepsy according to the presence of early clinical seizures or electroencephalographic (EEG) anomalies identified at admission to rehabilitation;
• demonstrate in vivo the activation of neuroplasticity by serotonin reuptake inhibitors drugs;
• evaluate in patients with hemiplegia / hemiparesis of upper limb undergoing Mirror Therapy, robotic rehabilitation and traditional physiotherapy, the presence of specific factors predictive of functional recovery, and of response to different treatments.

Conditions

Stroke Rehabilitation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1 study group

All patients hospitalized in 4 intensive rehabilitation Structures of Don Gnocchi Foundation during the enrollment period, suffering from acute (within 30 days) ischemic or emorragic stroke

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• age 18-90
• acute ischemic or hemorrhagic stroke (within 30 days)
• consent to participate and to anonymous processing of data.

-signing of informed consent for the participation in the sub-project.

-signing of informed consent for participation in the subproject.

Exclusion Criteria

-Stroke occurred more than 30 days after the transfer to intensive rehabilitation

• history of major psychiatric disorder or recent exacerbation
• global aphasia
• refusal of the patient to participate in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role: lead

Responsible Party

Francesca Cecchi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francesca Cecchi, Physician

Role: PRINCIPAL_INVESTIGATOR

IRCCS Don Carlo Gnocchi

Locations

Fondazione don Gnocchi

Florence, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Francesca Cecchi, Physician

Role: CONTACT

fcecchi@dongnocchi.it

05573931

Facility Contacts

Francesca Cecchi, Physician

Role: primary

fcecchi@dongnocchi.it

05573931

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Other Identifiers

FDG_STROKE

Identifier Type: -

Identifier Source: org_study_id