None listed
Conditions
Brief summary
A Very Early Rehabilitation Trial (AVERT) Randomised controlled trial of very early mobilisation (intervention) versus standard care (control) with blinded assessment of outcome and intention to treat anlaysis. A comprehensive cost eccectiveness sub study is included. It is hypothesised that early mobilisation of patients in addition to standard care alone, will reduce death and disability at 3 months, reduce the number and severity of stroke complications experienced by patients, resullt in a better quality of life and is cost effective.
Interventions
Patients are randomised to receive very early rehabilitation within 24 hours of the onset of stroke and for up to 14 days. The rehabilitation consists of protocol specified rehabilitation sessions of short duration, related to the patients normal activities of daily living. The rehabilitation is implemented by physiotherapists and nurses. Blinded assesssment of outcome is performed at 3 and 12 months.
Sponsors
National Stroke Research Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
First or recurrent stroke diagnosis, haemorrhage or infarct, admitted to a stroke unit within 24 hours of onset of stroke symptoms. Patients must at least react to verbal commands.
Exclusion criteria
Pre stroke mRS of 3,4 or 5 (previous significant disability)Deterioration in patients condition in the first hour resulting in admission to ICU, surgery or documented palliative treatment.Concurrent diagnosis of rapidly deteriorating disease.Unstable coronary or other medical condition which is judged by the investigator to pose a hazard to the patient by involvement in the trial.A confirmed or suspected lower limb fracture preventing implemetation of the protocoltPA patients can be included if the treating physician permits and mobilisation within 24 hours is permitted.Patients cannot be concurrently recruited to drug or other intervention trials. Vital signs not within protocol specified normal limits.
Outcome results
None listed