Status:
COMPLETED
A Very Early Rehabilitation Trial
Lead Sponsor:
Neuroscience Trials Australia
Collaborating Sponsors:
Singhealth Foundation
Chest, Heart and Stroke Association Scotland
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Phase 3, multicenter, international randomized controlled trial of a Very Early Mobilization(VEM) care rehabilitation protocol compared to standard post stroke care (SC). Participants receive either S...
Detailed Description
People who suffer a stroke are often left with disabilities such as weakness, or problems with speech, thinking, or control or bodily functions. Severe strokes often result in death. The results of a ...
Eligibility Criteria
Inclusion
- Informed consent
- Clinical diagnosis of first or recurrent stroke, hemorrhage or infarct.
- Recruited within 24 hours of onset of stroke symptoms
- Admission in a stroke care unit
- Consciousness: At a minimum patient must at least react to verbal commands.
Exclusion
- pre stroke mRS of 3,4 or 5
- Deterioration in patients condition resulting in direct admission to ICU, decision to palliate or surgery.
- Concurrent diagnosis of rapidly deteriorating disease
- Unstable coronary or other medical condition that is judged by the investigator to impose a hazard to the patient by involvement
- Patients unable to be mobilized within 24 hours of onset. (eg bed rest policy post tPA, lower limb fracture)
- Other interventional trials
- Systolic BP less than 110 or greater than 220mmHg
- Oxygen saturation of less than 92 % with supplementation
- Resting heart rate of less than 40 or greater than 110 beats per minute
- Temperature of greater than 38.5 degrees C
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2015
Estimated Enrollment :
2014 Patients enrolled
Trial Details
Trial ID
NCT01846247
Start Date
June 1 2006
End Date
January 1 2015
Last Update
April 15 2015
Active Locations (1)
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1
Florey Institute for Neuroscience and Mental health
Melbourne, Victoria, Australia, 3084