Very Early Rehabilitation in Acute Ischemic Stroke (VERIS-Brazil)
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01694992
|Contact: Simone RP Gobbato, Physiotherapist||55 51 9982 firstname.lastname@example.org|
|Contact: Sheila CO Martins, Physician||55 51 9962 email@example.com|
|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 firstname.lastname@example.org|
|Contact: Sheila CO Martins, Physician 55 51 9962 8467 email@example.com|
|Sub-Investigator: Simone RP Gobbato, Physiotherapist|
|Principal Investigator:||Sheila CO Martins, Physician||Hospital de Clínicas de Porto Alegre (Hospital)|