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Post Stroke Intensive Rehabilitation (PSR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03866057
Recruitment Status : Unknown
Verified May 2019 by Francesca Cecchi, Fondazione Don Carlo Gnocchi Onlus.
Recruitment status was:  Recruiting
First Posted : March 7, 2019
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
Francesca Cecchi, Fondazione Don Carlo Gnocchi Onlus

Study Description
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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.

Condition or disease
Stroke Rehabilitation

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.
Study Design
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Study Type : Observational
Estimated Enrollment : 270 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Stroke Intensive Rehabilitation: Predictors of Outcome and Response to Specific Interventions
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  1. change in Modified Barthel Index (mBI) [ Time Frame: 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 Outcome Measures :
  1. change in Modified Rankin score [ Time Frame: 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.

  2. change in Fugl Meyer Assessment (FMA) [ Time Frame: 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.

  3. change in communication ability (Scala di disabilità comunicativa -SDC) [ Time Frame: 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.

  4. change in Oxford Cognitive Score (OCS) [ Time Frame: 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.

  5. change in Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 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.

  6. change in Functional Ambulation Classification (FAC) [ Time Frame: 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.

  7. change in Trunk Control Test (TCT) [ Time Frame: 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.

  8. change in Numeric Rating Score (NRS) -Pain [ Time Frame: 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.

  9. change in Ashworth spasticity scale [ Time Frame: 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.

  10. change in National Institute of Health Stroke Scale (NIHSS) [ Time Frame: 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.

  11. Post Stroke Epilepsy [ Time Frame: Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2 ]
    We will report possible post stroke seizures.

  12. change in serum Brain Derived Neurotrophic factor (BDNF) epigenetic profile [ Time Frame: Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2 ]
    Neural plasticity


Biospecimen Retention:   Samples With DNA
A subgroup of those patients belonging to the IRCCS of Florence (stimate 90), after signing the informed consent, will offer a blood sample for genetic testing of Brain-Derived Neurotrophic Factor (BDNF) polymorphisms at admission (Time 0) and a blood sample for the study of epigenetic modifications of BDNF at the outpatient follow-up after 6 months (Time 2).

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03866057


Contacts
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Contact: Francesca Cecchi, Physician 05573931 fcecchi@dongnocchi.it

Locations
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Italy
Fondazione don Gnocchi Recruiting
Florence, Italy, 50143
Contact: Francesca Cecchi, Physician    05573931    fcecchi@dongnocchi.it   
Sponsors and Collaborators
Fondazione Don Carlo Gnocchi Onlus
Investigators
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Principal Investigator: Francesca Cecchi, Physician IRCCS Don Carlo Gnocchi
More Information
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Publications:
6. Cecchi F, Diverio M, Corbella E, del Zotto E, Marrazzo F, Speranza G, Gabrielli MA, Macchi C, Ricca M, Aprile A. Sviluppo di un protocollo condiviso di Fondazione don Gnocchi (FdG) per la Riabilitazione dello Stroke e sua implementazione in 2 Strutture FdG: Studio Pilota. SIMFER Settembre 2018
16. Ministero della salute. Decreto 7 dicembre 2017 - Regolamento recante modifiche ed integrazioni del decreto 27 ottobre 2000, n. 380 e successive modificazioni, concernente la scheda di dimissione ospedaliera (SDO)N.:16/2017
17. Padua L, Imbimbo, I.,Aprile I, Loreti C, Germanotta M, Coraci, D., Cruciani A, Carrozza MC and FDG Robotic Rehabilitation Group. The role of cognitive reserve in the choice of upper limb rehabilitation treatment after stroke. Robotic or conventional? A multicenter study of the Don Carlo Gnocchi Foundation. Jan 1 2019, Biosystems and Biorobotics.Springere international publishing, p. 513-517 5 p. (Biosystems and Biorobotics; vol. 21).

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Responsible Party: Francesca Cecchi, Principal Investigator, Fondazione Don Carlo Gnocchi Onlus
ClinicalTrials.gov Identifier: NCT03866057    
Other Study ID Numbers: FDG_STROKE
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Francesca Cecchi, Fondazione Don Carlo Gnocchi Onlus:
Stroke
Predictors of recovery
Neurological Rehabilitation
Genetic
 Epigenetic
Mirror Therapy
Neurophysiopathology
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases