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

Hospital de Clinicas de Porto Alegre

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Stroke

Treatments: Other: Early mobilization

Study type: Interventional

Funder types: Other

Identifiers

NCT01694992

11.0121

Details and patient eligibility

About

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.

Enrollment: 184 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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184 participants in 2 patient groups

Early mobilization

Experimental group

Description:

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).

Treatment:

Other: Early mobilization

Control

No Intervention group

Description:

The Control Group will follow within the routines of the hospital as is usually done.