Very Early Rehabilitation in Acute Ischemic Stroke (VERIS-Brazil)
|ClinicalTrials.gov Identifier: NCT01694992|
Recruitment Status : Unknown
Verified September 2012 by Hospital de Clinicas de Porto Alegre.
Recruitment status was: Recruiting
First Posted : September 27, 2012
Last Update Posted : September 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Other: Early mobilization||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||184 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 Start Date :||March 2012|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||August 2015|
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.
- 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.
- Minimum or no Disability [ Time Frame: three months ]Measured by the modified Ranking Scale with score of 0 to 1.
- 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.
- Long of stay at hospital [ Time Frame: three month ]Number of days in hospital
- Death [ Time Frame: three month ]Determined by a blinded review of the clinical details by the investigators.
- Incidence of complications [ Time Frame: three month ]Number of complications (pneumonia and deep vein thrombosis) at three month
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01694992
|Contact: Simone RP Gobbato, Physiotherapist||55 51 9982 email@example.com|
|Contact: Sheila CO Martins, Physician||55 51 9962 firstname.lastname@example.org|
|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 email@example.com|
|Contact: Sheila CO Martins, Physician 55 51 9962 8467 firstname.lastname@example.org|
|Sub-Investigator: Simone RP Gobbato, Physiotherapist|
|Principal Investigator:||Sheila CO Martins, Physician||Hospital de Clínicas de Porto Alegre (Hospital)|