Very Early Rehabilitation in Acute Ischemic Stroke

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Stroke

Intervention / Treatment
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* Other: Early mobilization


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early mobilization<br>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<br>* 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).<br>* Other names: Early Physiotherapy Program;|
| No Intervention: Control<br>The Control Group will follow within the routines of the hospital as is usually done. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | three months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Early Ambulation, Rehabilitation, Physical Therapy, Randomized controlled trial