Post Stroke Intensive Rehabilitation (PSR)

May 23, 2019 updated by: Francesca Cecchi, Fondazione Don Carlo Gnocchi Onlus

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

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

270

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Florence, Italy, 50143
        • Recruiting
        • Fondazione Don Gnocchi
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
Admission: Time 0; Discharge,up to 3/4 weeks: Time 1; 6-months Follow up: Time 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.
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)
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.
Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
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.
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)
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.
Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
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.
Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
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.
Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
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.
Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
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.
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)
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.
Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
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.
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
Time Frame: Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2
Neural plasticity
Admission: Time 0; Discharge, up to 3/4 weeks: Time 1; 6-months Follow up: Time 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2019

Primary Completion (ANTICIPATED)

December 31, 2019

Study Completion (ANTICIPATED)

December 31, 2020

Study Registration Dates

First Submitted

February 24, 2019

First Submitted That Met QC Criteria

March 5, 2019

First Posted (ACTUAL)

March 7, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 24, 2019

Last Update Submitted That Met QC Criteria

May 23, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDG_STROKE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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