None listed
Conditions
Brief summary
The aim of this study is to define the dose of early rehabilitation intervention that provides the most benefit for people with ischaemic stroke of mild and moderate severity. 4 separate rehabilitation intervention regimens (different number, length and intensity of training sessions) will be implemented by physiotherapists and nurses in stroke units immediately post stroke. Participants will be followed up at 3 and 6 months post stroke. 2,700 patients with mild to moderate stroke will be recruited in Australia, New Zealand, Singapore, Malaysia, India and the UK. We hypothesise that the optimal dose intervention regimen will result in an improved outcome at 3 months post stroke, with less complications at 14 days and better quality of life at 6 months post stroke.
Interventions
4 groups of differing doses of mobility training provided by physiotherapists and nurses directly in the acute phase of stroke recovery (until discharge or until 14 days post stroke (whichever occurs first.)
Participants are randomised to receive between 1 and 4 sessions of mobility training per day, at an intensity that is tolerable to the participant. Session times are short, no longer than 20 minutes. Intervention is provided by the Physiotherapists at tolerable dose, noted as mild moderat
4 groups of differing doses of mobility training provided by physiotherapists and nurses directly in the acute phase of stroke recovery (until discharge or until 14 days post stroke (whichever occurs first.) Participants are randomised to receive between 1 and 4 sessions of mobility training per day, at an intensity that is tolerable to the participant. Session times are short, no longer than 20 minutes. Intervention is provided by the Physiotherapists at tolerable dose, noted as mild moderate and vigorous intensity as determined by the BORG and physiological measures including heart and respiratory rates, O2 saturation and Blood pressure. Frequency of sessions are fixed depending on randomisation group. The details of the therapy groups, timing and intensity is outlined in an intervention protocol that is provided to staff providing the therapy. To avoid unblinding or further treatment bias, this protocol will remain inhouse to avoid contamination, until trial end at which time the details will be published. All aspects of all sessions will be recorded on a therapy recording form and entered into online data base. Sessions will be monitored for adherence to protocol by the research team.
Sponsors
The Florey Institute of Neuroscience and Mental Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Ischaemic stroke (first or recurrent) Aged 18 years or over Ability to be enrolled within 48 hrs of onset of stroke symptoms. Mild (NIHSS 0-7) or moderate stroke severity (NIHSS 8 - 16) Pre stroke mRS of 0-2 Participants are medically stable at the time of enrollment (physiological criteria = Patient rousable, SBP>120mmHg and <180MmmHg, 02 saturation >92%, HR >40 and <100, Temperature <38.5 degrees
Exclusion criteria
Patients with pre stroke mRS of 3,4, or 5 Diagnosis of haemorrhagic stroke or transient ischaemic attack Severe stroke (NIHSS >16) Co morbid progressive neurological conditions Severe heart failure, unstable coronary condition or any other condition that are judged by the investigator to impose a hazard to the participant if involved in the trial (including COVID 19) Concurrent diagnosis of rapidly deteriorating disease (eg terminal cancer) Deterioration following admission resulting in a documented clinical decision for palliative treatment or immediate surgery A lower limb fracture or other disability which deems the participant unable to participate in mobility training Patients with no evident mobility problems Patients expected to be discharged within 3 days of trial enrollment Current participation in a drug or other intervention trial
Outcome results
None listed