Post Stroke Intensive Rehabilitation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Post Stroke Intensive Rehabilitation: Predictors of Outcome and Response to Specific Interventions

Conditions
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Stroke Rehabilitation

Participation Criteria
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Eligibility Criteria
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Inclusion criteria: age 18-90 acute ischemic or hemorrhagic stroke (within 30 days) consent to participate and to anonymous processing of data. Additional inclusion criteria for Sub-project Neurophysiological Markers: -signing of informed consent for the participation in the sub-project. Additional inclusion criteria for Epigenetic subproject: -signing of informed consent for participation in the subproject. Exclusion Criteria: -Stroke occurred more than 30 days after the transfer to intensive rehabilitation Additional exclusion criteria for Epigenetic subproject (for retrospective analysis): history of major psychiatric disorder or recent exacerbation global aphasia refusal of the patient to participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| 1 study group<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Modified Barthel Index (mBI) | Functional recovery; Score from 0 to 100; higher values represent a better outcome. | Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Modified Rankin score | Functional recovery; Score from 0 to 6; higher values represent a worse outcome. | Admission: Time 0; Discharge,up to 3/4 weeks: Time 1; 6-months Follow up: Time 2 | 
| change in Fugl Meyer Assessment (FMA) | Sensomotor recovery; Total score from 0 to 64, Upper-limb subscale 0-36; lower-limb subscale 0-28. Higher values represent a better outcome. | Admission: Time 0; Discharge,up to 3/4 weeks: Time 1; 6-months Follow up: Time 2 | 
| change in communication ability (Scala di disabilità comunicativa -SDC) | Communication recovery; Score from 0 to 4; higher values represent a better outcome. | Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2 | 
| change in Oxford Cognitive Score (OCS) | The Oxford Cognitive Screen (OCS) describes the cognitive deficits after stroke.The scale consists of 10 tasks encompassing five cognitive domains: attention and executive function, language, memory, number processing, and praxis. | Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2 | 
| change in Hospital Anxiety and Depression Scale (HADS) | depression and anxiety; Score from 0 to 21, subitems Depression and Anxiety. Higher values represent a worse outcome. | Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2 | 
| change in Functional Ambulation Classification (FAC) | Walking recovery; Score from 0 to 5. Higher values represent a better outcome. | Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2 | 
| change in Trunk Control Test (TCT) | Trunk control recovery; Score from 0 to 100;Higher values represent a better outcome. | Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2 | 
| change in Numeric Rating Score (NRS) -Pain | Pain assessment; Score from 0 to 10; Higher values represent a worse outcome. | Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2 | 
| change in Ashworth spasticity scale | Spasticity; Score from 0 to 4; Higher values represent a worse outcome. | Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2 | 
| change in National Institute of Health Stroke Scale (NIHSS) | clinical recovery; 15 items scored from 3 to 4 ( total score from 0 to 42). Higher values represent a worse outcome. | Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2 | 
| Post Stroke Epilepsy | We will report possible post stroke seizures. | Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2 | 
| change in serum Brain Derived Neurotrophic factor (BDNF) epigenetic profile | Neural plasticity | Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Predictors of recovery, Neurological Rehabilitation, Genetic, Epigenetic, Mirror Therapy, Neurophysiopathology