Stroke Rehabilitation
Conditions
Keywords
Stroke, Predictors of recovery, Neurological Rehabilitation, Genetic, Epigenetic, Mirror Therapy, Neurophysiopathology
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.
Interventions
None listed
Sponsors
Fondazione Don Carlo Gnocchi Onlus
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in Modified Barthel Index (mBI) | Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2 | Functional recovery; Score from 0 to 100; higher values represent a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in Fugl Meyer Assessment (FMA) | Admission: Time 0; Discharge,up to 3/4 weeks: Time 1; 6-months Follow up: Time 2 | Sensomotor recovery; Total score from 0 to 64, Upper-limb subscale 0-36; lower-limb subscale 0-28. Higher values represent a better outcome. |
| change in communication ability (Scala di disabilità comunicativa -SDC) | Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2 | Communication recovery; Score from 0 to 4; higher values represent a better outcome. |
| change in Oxford Cognitive Score (OCS) | Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2 | 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. |
| change in Hospital Anxiety and Depression Scale (HADS) | Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2 | depression and anxiety; Score from 0 to 21, subitems Depression and Anxiety. Higher values represent a worse outcome. |
| change in Functional Ambulation Classification (FAC) | Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2 | Walking recovery; Score from 0 to 5. Higher values represent a better outcome. |
| change in Modified Rankin score | Admission: Time 0; Discharge,up to 3/4 weeks: Time 1; 6-months Follow up: Time 2 | Functional recovery; Score from 0 to 6; higher values represent a worse outcome. |
| change in Numeric Rating Score (NRS) -Pain | Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2 | Pain assessment; Score from 0 to 10; Higher values represent a worse outcome. |
| change in Ashworth spasticity scale | Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2 | Spasticity; Score from 0 to 4; Higher values represent a worse outcome. |
| change in National Institute of Health Stroke Scale (NIHSS) | Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2 | clinical recovery; 15 items scored from 3 to 4 ( total score from 0 to 42). Higher values represent a worse outcome. |
| Post Stroke Epilepsy | Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2 | We will report possible post stroke seizures. |
| change in serum Brain Derived Neurotrophic factor (BDNF) epigenetic profile | Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2 | Neural plasticity |
| change in Trunk Control Test (TCT) | Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2 | Trunk control recovery; Score from 0 to 100;Higher values represent a better outcome. |
Countries
Italy
Contacts
Primary ContactFrancesca Cecchi, Physician
Outcome results
None listed