Stroke, Stroke Patients, Stroke; Sequelae, Young Adults
Conditions
Keywords
recovery, young stroke, ischemic stroke, hemorrhagic stroke, poststroke fatigue, post-stroke cognitive impairment, function, mood
Brief summary
The Investigators 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. The 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. The Investigators will 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, the Investigators will 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 prepare for larger studies in the future.
Interventions
OTHERObservational Cohort
The deep phenotyping observational study observes young adult stroke recovery trajectories and will also explore potential recovery biomarkers via: advanced MRI imaging; samples including blood, saliva, urine and hair stored for future analysis that may include (but is not limited to) proteomics, genomics and cortisol; and, a PET scan sub study involving \~20 participants (additional inclusion criteria) exploring the association of reactive astrogliosis with recovery outcomes using the experimental Positron Emission Tomography 18F-SMBT-1 tracer (AU TGA CTN in place). Associations with personal and environmental factors including: physical activity and sleep quality via device (Actigraph and Somfit) and self-report; exposures such as home and work environments, diet, socioeconomic status, and dental health; quality of life, resilience, and locus of control. Monitor healthcare utilisation, changes in medication and medical condition, participant experience and response to the assessments.
Sponsors
The Florey Institute of Neuroscience and Mental Health
University of Melbourne
University of Newcastle, Australia
Austin Health
La Trobe University
The Alfred
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Between 18 and 55 years. 2. Within one month of acute stroke confirmed with standard of care brain imaging or clinical diagnosis or for those for whom recruitment \<1 month of stroke is not possible they may be recruited to participate within 3-months of stroke
Exclusion criteria
1. Severe, intercurrent or progressive illness likely to EITHER 1. Have a prognosis for survival under 24 months; OR 2. In the opinion of the investigator will mask the importance to the individual participant data (e.g. severe MS, dementia, etc) 2. Major psychiatric condition requiring medical intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implementability (feasibility, fidelity and acceptability) | From enrolment to the six month assessment visit | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue Severity Scale | 6 months | 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. |
| Visual Analogue Scale to Assess Fatigue (VAS-F) | Assessment at <1, 3- and 6-months post stroke | 18-item visual analogue scale of fatigue and energy items. |
| Modified Fatigue Impact Scale (MFIS) is a multidimensional scale that reports physical, psychological and cognitive aspects of fatigue | 6 months | 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. |
| Cognitive Assessment | 6 months | 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. |
| modified Rankin Scale (mRS) | 6 months | Single-item evaluation of global disability. Assessed at \<1-month, 3- and 6-months post stroke |
| 10 metre walk test (10mWT) | 6 months | Gait assessment, evaluated \<1-month, 3- and 6-months post stroke |
| Visual Analogue Scale of the Impact of Fatigue on Communication Ability | 6 months | 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. |
Countries
Australia
Contacts
CONTACTEmily Ramage, BPhysio, PhD
CONTACTMarie Ferraro, BSc
PRINCIPAL_INVESTIGATORVincent Thijs, MD, PhD
Florey Institute of Neuroscience and Mental Health
Outcome results
None listed