A Very Early Rehabilitation Trial "AVERT"

Recruiting

Phase N/A Results

Trial Description

To determine if very early mobilization (VEM) of stroke patients in addition to standard care compared to standard care (SC) alone is more effective in lowering mortality, disability, and severity of complications at 3 months and at improving quality of life at 12 months.

Interventions

Trial Design

Multicenter, randomized, controlled trial.

Patient Involvement

Patients will be randomized into one of two groups: the Standard Care (SC) group is usual stroke unit care, or to the treatment group of Very Early Mobilization (VEM). The VEM group receive additional mobilization sessions (physiotherapy and nursing)over the intervention period of 14 days, or until the patient is discharged from stroke unit care, whichever is sooner. VEM is provided by trained physiotherapy and nursing staff according to a detailed protocol, and patients are carefully monitored for any adverse events.

Outcomes

Type Measure Time Frame Safety Issue
Secondary Safety: Mortality rate and the rate and severity of important medical events (stroke progression, recurrent stroke, falls, angina, myocardial infarctions, deep venous thromboses, pulmonary emboli, pressure sores, chest infections, urinary tract infections) at 3 months; and all adverse events during the intervention period. Health-related quality of life: cognitive function using Montreal Cognitive Assessment (MoCA) at 3 months: Assessment of Quality of Life and Irritability, Depression and Anxiety scale; at 3 and 12 months. Cost effectiveness and cost utility: Comprehensive questionnaire at 3 and 12 months and baseline mRS. Long term efficacy: mRS at 12 months. Activity limitations: Time to walking 50 metres; Rivermead Motor Assessment and Barthel Index at 3 and 12 months. Dose-response: Intervention dose and Modified Rankin Score at 3 and 12 months. Patient severity and efficacy: Mild, moderate and severe stroke (NIHSS) and mRS at 3 and 12 months.

Sponsors

National Stroke Research Institute