Very Early Rehabilitation in Acute Ischemic Stroke (VERIS-Brazil)

September 25, 2012 updated by: Hospital de Clinicas de Porto Alegre

Randomized Clinical Trial of Very Early Rehabilitation Compared With Conventional Rehabilitation in Acute Ischemic Stroke in the Vascular Unit of the Hospital de Clínicas de Porto Alegre - HCPA

The purpose of this study is to evaluate the effectiveness of a rehabilitation (physiotherapy) program in patients with acute ischemic stroke in Acute Vascular Unit and in general ward of Hospital de Clínicas de Porto Alegre, and to verify the degree of disability at fourteenth and third month, functional improvement at third month, the frequency of deaths and incidence of complications due to immobility and quantify the time spent in hospital.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

184

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

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

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Recruiting
        • Hospital de Clínicas de Porto Alegre (Hospital)
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Simone RP Gobbato, Physiotherapist

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with clinical diagnosis of acute ischemic stroke (first or recurrent) confirmed by CCT or MRI admitted to the Acute Vascular Unit of HCPA between the first 48 hours of onset of symptoms.
  • Patients older than 18 years.
  • Patients clinically and hemodynamically stable (SBP 120-220 mmHg, SatO2 up to 92% with or without supplementation, HR between 60 and 100 bmp, body temperature below 38 and RR below 25 bpm).
  • Patients are able to react to verbal commands even without being fully alert (Glasgow Scale above 8).
  • Prior Rankin until 3
  • Motor deficit and / or coordination measured by the NIHSS

Exclusion Criteria:

  • Patients with clinical and / or hemodynamic instability
  • Patients with hemorrhagic stroke or TIA (transient ischemic attack).
  • Patients with progressive neurological disease and acute coronary disease and / or unstable.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early mobilization
The Intervention Group - Early Mobilization - will follow the early physiotherapy program within the first 24 - 48 hours after stroke, five times per week for 30 plus a time spent out of bed (sitting).
Other: Early mobilization
The Intervention Group - Early Mobilization - will follow the early physiotherapy program within the first 24 - 48 hours after acute ischemic stroke, five times per week for 30 minutes plus time to spent out of bed (sitting).
Other Names:
  • Early Physiotherapy Program
No Intervention: Control
The Control Group will follow within the routines of the hospital as is usually done.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disability
Time Frame: three months
Outcome measure are assessed by Modified Rankin Scale. Good outcome was predefined as an mRS score of 0 to 2 and poor outcome of 3 to 6.
three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minimum or no Disability
Time Frame: three months
Measured by the modified Ranking Scale with score of 0 to 1.
three months
Independence in activities of daily living
Time Frame: three months
Measured by the modified Barthel Index, where score < 75 indicate dependence and score > 75 is independence.
three months
Long of stay at hospital
Time Frame: three month
Number of days in hospital
three month
Death
Time Frame: three month
Determined by a blinded review of the clinical details by the investigators.
three month
Incidence of complications
Time Frame: three month
Number of complications (pneumonia and deep vein thrombosis) at three month
three month

Collaborators and Investigators

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

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Sheila CO Martins, Physician, Hospital de Clínicas de Porto Alegre (Hospital)

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

March 1, 2012

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

August 1, 2015

Study Registration Dates

First Submitted

September 25, 2012

First Submitted That Met QC Criteria

September 25, 2012

First Posted (Estimate)

September 27, 2012

Study Record Updates

Last Update Posted (Estimate)

September 27, 2012

Last Update Submitted That Met QC Criteria

September 25, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11.0121

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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