We are running a small, early-phase research study across several hospitals in Melbourne, Australia. The study will involve up to 100 young adults between the ages of 18 and 55 who have had a stroke. Our goal is to test how practical it is to carry out a detailed health assessment process-called "deep phenotyping"-with this group. This process involves collecting a wide range of information and samples from stroke survivors to better understand each participant's condition. We'll look at how well this approach works in practice, including how easy it is to use, whether it's done consistently, and how acceptable it is to participants. At the same time, we'll also explore how different factors-such as biological markers (biomarkers), age, sex, type of stroke, lifestyle, and environment-might be related to stroke recovery. This pilot study will help us prepare for larger studies in the future.
Study Type
OBSERVATIONAL
Enrollment
100
Not applicable: Observational cohort study
Florey Institute of Neuroscience and Mental Health, Melbourne Brain Centre
Heidelberg, Victoria, Australia
Implementability (feasibility, fidelity and acceptability)
Evaluation of the implementability will include assessment of the protocol's: * Feasibility, e.g. * Recruitment rate * Retention * Proportion of participants screened that enrolled * Safety via adverse events * Fidelity, e.g. * Proportion of assessments attended * Proportion of data collected and biobanked or analysed * Acceptability, e.g. o Participant acceptability surveys
Time frame: From enrolment to the six month assessment visit
Fatigue Severity Scale
FSS: A 9-item (or 7-item with the first two items removed) measure of fatigue impairment. Measured at baseline (\<1month post stroke), 3- and 6-months post stroke.
Time frame: 6 months
Visual Analogue Scale to Assess Fatigue (VAS-F)
18-item visual analogue scale of fatigue and energy items.
Time frame: Assessment at <1, 3- and 6-months post stroke
Modified Fatigue Impact Scale (MFIS) is a multidimensional scale that reports physical, psychological and cognitive aspects of fatigue
A multidimensional 21-item measure that evaluates physical, psychological and cognitive aspects of fatigue. Measured at baseline (\<1month post stroke), 3- and 6-months post stroke.
Time frame: 6 months
Cognitive Assessment
Assessment to evaluate cognitive domains such as visuospatial memory, auditory verbal learning, visual attention, task switching, verbal fluency, and verbal short-term and working memory. Assessment \<1-month, 3- and 6-months post stroke.
Time frame: 6 months
modified Rankin Scale (mRS)
Single-item evaluation of global disability. Assessed at \<1-month, 3- and 6-months post stroke
Time frame: 6 months
10 metre walk test (10mWT)
Gait assessment, evaluated \<1-month, 3- and 6-months post stroke
Time frame: 6 months
Visual Analogue Scale of the Impact of Fatigue on Communication Ability
Visual analogue scale (0-10) assessing the impact of fatigue on communication ability. Measured at baseline (\<1month post stroke), 3- and 6-months post stroke.
Time frame: 6 months
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