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| ID | Type | Description | Link |
|---|---|---|---|
| RARUR000042 | Other Grant/Funding Number | Medical Research Future Fund (Australia) |
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| Name | Class |
|---|---|
| University of Melbourne | OTHER |
| University of Newcastle, Australia | OTHER |
| Austin Health | OTHER_GOV |
| La Trobe University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Young adult stroke survivors (age 18 to 55 inclusive) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational Cohort | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Implementability (feasibility, fidelity and acceptability) | Evaluation of the implementability will include assessment of the protocol's:
| From enrolment to the six month assessment visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Visual Analogue Scale to Assess Fatigue (VAS-F) |
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Inclusion Criteria:
Exclusion Criteria:
Severe, intercurrent or progressive illness likely to EITHER
Major psychiatric condition requiring medical intervention
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Young adult stroke survivors within 3 months of stroke
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emily Ramage, BPhysio, PhD | Contact | +61 3 90357000 | emily.ramage@florey.edu.au | |
| Marie Ferraro, BSc | Contact | +61390357000 | marie.ferraro@student.unimelb.edu.au |
| Name | Affiliation | Role |
|---|---|---|
| Vincent Thijs, MD, PhD | The Florey Institute of Neuroscience and Mental Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Austin Health | Recruiting | Heidelberg | Victoria | 3039 | Australia |
Sharing of individual patient data will be considered upon reasonable request by qualified researchers with appropriate IRB/HREC approval
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| D000083302 | Hemorrhagic Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| OTHER |
| The Alfred | OTHER |
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18-item visual analogue scale of fatigue and energy items.
| 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. | 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. | 6 months |
| modified Rankin Scale (mRS) | Single-item evaluation of global disability. Assessed at <1-month, 3- and 6-months post stroke | 6 months |
| 10 metre walk test (10mWT) | Gait assessment, evaluated <1-month, 3- and 6-months post stroke | 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. | 6 months |
| Florey Institute of Neuroscience and Mental Health, Melbourne Brain Centre | Not yet recruiting | Heidelberg | Victoria | 3084 | Australia |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |