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NCT Number: NCT07019493

Young Stroke Service Deep Phenotyping: Exploring Recovery in Young Adult Survivors of Stroke

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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Key information

Conditions

Stroke Patients Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhagic Stroke Ischemic Stroke Nervous System Diseases Stroke Stroke; Sequelae Vascular Diseases Young Adults

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Austin Health, Heidelberg, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Deep phenotyping

Primary outcomes

  1. Implementability (feasibility, fidelity and acceptability)

    Time frame: 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 outcomes

  1. Fatigue Severity Scale

    Time frame: 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.

  2. Visual Analogue Scale to Assess Fatigue (VAS-F)

    Time frame: Assessment at <1, 3- and 6-months post stroke

    18-item visual analogue scale of fatigue and energy items.

  3. Modified Fatigue Impact Scale (MFIS) is a multidimensional scale that reports physical, psychological and cognitive aspects of fatigue

    Time frame: 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.

  4. Cognitive Assessment

    Time frame: 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.

  5. modified Rankin Scale (mRS)

    Time frame: 6 months

    Single-item evaluation of global disability. Assessed at <1-month, 3- and 6-months post stroke

  6. 10 metre walk test (10mWT)

    Time frame: 6 months

    Gait assessment, evaluated <1-month, 3- and 6-months post stroke

  7. Visual Analogue Scale of the Impact of Fatigue on Communication Ability

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emily Ramage, BPhysio, PhD

CONTACT

[email protected]

+61 3 90357000

Marie Ferraro, BSc

CONTACT

[email protected]

+61390357000

Sponsors and collaborators

Lead sponsor

The Florey Institute of Neuroscience and Mental Health

Other

Collaborators

  • Austin Health
  • La Trobe University
  • The Alfred
  • University of Melbourne
  • University of Newcastle, Australia

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 13, 2025
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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