Clinical trial NCT03866057: Post Stroke Intensive Rehabilitation
Official title: Post Stroke Intensive Rehabilitation: Predictors of Outcome and Response to Specific Interventions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke Rehabilitation
Keywords: Stroke
Predictors of recovery
Neurological Rehabilitation
Genetic
Epigenetic
Mirror Therapy
Neurophysiopathology
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2019-03-07
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutively recruited all patients hospitalized in 4 intensive rehabilitative Structures of Don Gnocchi Foundation (IRCCS Firenze, Massa, Fivizzano, La Spezia). Is estimated to recruit a sample of 270 patients (approximately 90 in Florence, 90 in Spezia and 90 in Massa and Fivizzano). Sampling will be performed on presentation, including in the study all the subjects that meet the inclusion criteria listed above. For the sub-project Markers Neurophysiological it is planned to recruit all the patients involved in the general project related to Florence and La Spezia (estimate: 180). For the epigenetic subproject we estimate to involve all the patients recruited in the general project related to Florence (estimate: 90).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: change in Modified Barthel Index (mBI)
timeFrame: Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
Secondary outcomes:
measure: change in Modified Rankin score
timeFrame: Admission: Time 0; Discharge,up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
measure: change in Fugl Meyer Assessment (FMA)
timeFrame: Admission: Time 0; Discharge,up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
measure: change in communication ability (Scala di disabilità comunicativa -SDC)
timeFrame: Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
measure: change in Oxford Cognitive Score (OCS)
timeFrame: Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
measure: change in Hospital Anxiety and Depression Scale (HADS)
timeFrame: Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
measure: change in Functional Ambulation Classification (FAC)
timeFrame: Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
measure: change in Trunk Control Test (TCT)
timeFrame: Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
measure: change in Numeric Rating Score (NRS) -Pain
timeFrame: Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
measure: change in Ashworth spasticity scale
timeFrame: Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
measure: change in National Institute of Health Stroke Scale (NIHSS)
timeFrame: Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
measure: Post Stroke Epilepsy
timeFrame: Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
measure: change in serum Brain Derived Neurotrophic factor (BDNF) epigenetic profile
timeFrame: Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Fondazione don Gnocchi
Study officials:
affiliation: IRCCS Don Carlo Gnocchi
name: Francesca Cecchi, Physician
role: PRINCIPAL_INVESTIGATOR
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