NCT01694992
Unknown
Phase 1
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
ConditionsStroke
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Hospital de Clinicas de Porto Alegre
- Enrollment
- 184
- Locations
- 1
- Primary Endpoint
- Disability
- Last Updated
- 13 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Minimum or no Disability(three months)
- Independence in activities of daily living(three months)
- Long of stay at hospital(three month)
- Death(three month)
- Incidence of complications(three month)
Study Sites (1)
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