A Very Early Rehabilitation Trial (AVERT)
- Conditions
- StrokeCirculatory SystemStroke, not specified as haemorrhage or infarction
- Registration Number
- ISRCTN98129255
- Lead Sponsor
- HS Greater Glasgow and Clyde (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 2104
1. First or recurrent stroke diagnosis
2. Haemorrhage or infarct
3. Admitted to a stroke unit within 24 hours of onset of stroke symptoms.
4. Patients must at least react to verbal commands.
1. Pre stroke mRS of 3, 4 or 5 (previous significant disability)
2. Deterioration in patients condition in the first hour resulting in admission to ICU, surgery or documented palliative treatment.
3. Concurrent diagnosis of rapidly deteriorating disease.
4. Unstable coronary or other medical condition which is judged by the investigator to pose a hazard to the patient by involvement in the trial.
5. A confirmed or suspected lower limb fracture preventing implementation of the protocol tPA. Patients can be included if the treating physician permits and mobilisation within 24 hours is permitted.
6. Patients cannot be concurrently recruited to drug or other intervention trials.
7. Vital signs not within protocol specified normal limits.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Modified Rankin Score measured at 3 months after randomisation
- Secondary Outcome Measures
Name Time Method 1. Barthel Index<br>2. Irritability Depression and Anxiety Scale<br>3. Assessment of Quality of Life Instrument<br>4. Time to walking 50 meters unassisted<br>5. Montreal Cognitive Assessment (MoCA) (at 3 months only)<br>6. Rivermead Motor Assessment Scale<br>7. Important medical events (falls, stroke progression, recurrent stroke, pulmonary embolism, deep vein thrombosis, myocardial infarction, angina, urinary tract infection, pressure sores, pneumonia, depression), from confirmed source documents.