Very Early Rehabilitation in Acute Ischemic Stroke

Phase 1

• Conditions: Stroke
• Interventions: Other: Early mobilization

• Registration Number: NCT01694992
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Status Verified: 2012-09
• Study First Submitted: 2012-09-25
• Study First Submitted QC: 2012-09-25
• Last Update Submitted: 2012-09-25
• Study First Posted: 2012-09-27
• Last Update Posted: 2012-09-27
• Primary Completion: 2012-12
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 184

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early mobilization	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).

Primary Outcome Measures

Name	Time	Method
Disability	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 Outcome Measures

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

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre (Hospital); 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil