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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Hospital de Clinicas de Porto Alegre
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT01694992
First received: September 25, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Stroke
Other: Early mobilization
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Disability [ Time Frame: three months ] [ Designated as safety issue: No ]
    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 [ Time Frame: three months ] [ Designated as safety issue: No ]
    Measured by the modified Ranking Scale with score of 0 to 1.

  • Independence in activities of daily living [ Time Frame: three months ] [ Designated as safety issue: No ]
    Measured by the modified Barthel Index, where score < 75 indicate dependence and score > 75 is independence.

  • Long of stay at hospital [ Time Frame: three month ] [ Designated as safety issue: No ]
    Number of days in hospital

  • Death [ Time Frame: three month ] [ Designated as safety issue: Yes ]
    Determined by a blinded review of the clinical details by the investigators.

  • Incidence of complications [ Time Frame: three month ] [ Designated as safety issue: No ]
    Number of complications (pneumonia and deep vein thrombosis) at three month


Estimated Enrollment: 184
Study Start Date: March 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Early Physiotherapy Program
No Intervention: Control
The Control Group will follow within the routines of the hospital as is usually done.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01694992

Contacts
Contact: Simone RP Gobbato, Physiotherapist 55 51 9982 3387 sissipoletto@hotmail.com
Contact: Sheila CO Martins, Physician 55 51 9962 8467 scmartins@hcpa.ufrgs.br

Locations
Brazil
Hospital de Clínicas de Porto Alegre (Hospital) Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Contact: Simone RP Gobbato, Physiotherapist    55 51 9982 3387    sissipoletto@hotmail.com   
Contact: Sheila CO Martins, Physician    55 51 9962 8467    scmartins@hcpa.ufrgs.br   
Sub-Investigator: Simone RP Gobbato, Physiotherapist         
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: Sheila CO Martins, Physician Hospital de Clínicas de Porto Alegre (Hospital)
  More Information

No publications provided

Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01694992     History of Changes
Other Study ID Numbers: 11.0121
Study First Received: September 25, 2012
Last Updated: September 25, 2012
Health Authority: Brazil: Associação Fundo de Incentivo à Pesquisa
Brazil: Ethics Committee
Brazil: National Committee of Ethics in Research

Keywords provided by Hospital de Clinicas de Porto Alegre:
Stroke
Early Ambulation
Rehabilitation
Physical Therapy
Randomized controlled trial

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 30, 2014