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

Primary Purpose

Stroke

Status
Unknown status
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Early mobilization
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Early Ambulation, Rehabilitation, Physical Therapy, Randomized controlled trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital de Clínicas de Porto Alegre (Hospital)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Early mobilization

Control

Arm Description

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).

The Control Group will follow within the routines of the hospital as is usually done.

Outcomes

Primary Outcome Measures

Disability
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.

Secondary Outcome Measures

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

Full Information

First Posted
September 25, 2012
Last Updated
September 25, 2012
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT01694992
Brief Title
Very Early Rehabilitation in Acute Ischemic Stroke
Acronym
VERIS-Brazil
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
August 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Early Ambulation, Rehabilitation, Physical Therapy, Randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
184 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early mobilization
Arm Type
Experimental
Arm Description
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).
Arm Title
Control
Arm Type
No Intervention
Arm Description
The Control Group will follow within the routines of the hospital as is usually done.
Intervention Type
Other
Intervention Name(s)
Early mobilization
Other Intervention Name(s)
Early Physiotherapy Program
Intervention Description
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).
Primary Outcome Measure Information:
Title
Disability
Description
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.
Time Frame
three months
Secondary Outcome Measure Information:
Title
Minimum or no Disability
Description
Measured by the modified Ranking Scale with score of 0 to 1.
Time Frame
three months
Title
Independence in activities of daily living
Description
Measured by the modified Barthel Index, where score < 75 indicate dependence and score > 75 is independence.
Time Frame
three months
Title
Long of stay at hospital
Description
Number of days in hospital
Time Frame
three month
Title
Death
Description
Determined by a blinded review of the clinical details by the investigators.
Time Frame
three month
Title
Incidence of complications
Description
Number of complications (pneumonia and deep vein thrombosis) at three month
Time Frame
three month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simone RP Gobbato, Physiotherapist
Phone
55 51 9982 3387
Email
sissipoletto@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sheila CO Martins, Physician
Phone
55 51 9962 8467
Email
scmartins@hcpa.ufrgs.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheila CO Martins, Physician
Organizational Affiliation
Hospital de Clínicas de Porto Alegre (Hospital)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre (Hospital)
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simone RP Gobbato, Physiotherapist
Phone
55 51 9982 3387
Email
sissipoletto@hotmail.com
First Name & Middle Initial & Last Name & Degree
Sheila CO Martins, Physician
Phone
55 51 9962 8467
Email
scmartins@hcpa.ufrgs.br
First Name & Middle Initial & Last Name & Degree
Simone RP Gobbato, Physiotherapist

12. IPD Sharing Statement

Citations:
PubMed Identifier
34695300
Citation
Clark B, Whitall J, Kwakkel G, Mehrholz J, Ewings S, Burridge J. The effect of time spent in rehabilitation on activity limitation and impairment after stroke. Cochrane Database Syst Rev. 2021 Oct 25;10(10):CD012612. doi: 10.1002/14651858.CD012612.pub2.
Results Reference
derived

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Very Early Rehabilitation in Acute Ischemic Stroke

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