Young Stroke Service Deep Phenotyping: Exploring Recovery in Young Adult Survivors of Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Observational Cohort.
- Who it may be relevant to
- Registry conditions: Stroke Patients, Stroke, Stroke; Sequelae, Young Adults. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Other Observational 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 experimen
Primary outcome measures
- Implementability (feasibility, fidelity and acceptability) [Time frame: From enrolment to the six month assessment visit]
Secondary outcome measures (7)
- Fatigue Severity Scale [Time frame: 6 months]
- Visual Analogue Scale to Assess Fatigue (VAS-F) [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 [Time frame: 6 months]
- Cognitive Assessment [Time frame: 6 months]
- modified Rankin Scale (mRS) [Time frame: 6 months]
- 10 metre walk test (10mWT) [Time frame: 6 months]
- Visual Analogue Scale of the Impact of Fatigue on Communication Ability [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- Between 18 and 55 years.
- 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
- Severe, intercurrent or progressive illness likely to EITHER
- Have a prognosis for survival under 24 months; OR
- In the opinion of the investigator will mask the importance to the individual participant data (e.g. severe MS, dementia, etc)
- Major psychiatric condition requiring medical intervention
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Australia · 2 centers
- Austin Health — Heidelberg
- Florey Institute of Neuroscience and Mental Health, Melbourne Brain Centre — Heidelberg
Identifiers
NCT: NCT07019493 · Protocol One YSSDP · RARUR000042