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

Not yet recruiting

• Conditions: Stroke Patients; Stroke; Stroke; Sequelae; Young Adults

• Registration Number: NCT07019493
• Lead Sponsor: The Florey Institute of Neuroscience and Mental Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-30
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-05
• Last Update Submitted: 2025-06-05
• Study First Posted: 2025-06-13
• Last Update Posted: 2025-06-13
• Study Start: 2025-06-30
• Primary Completion: 2026-12-31
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Florey Institute of Neuroscience and Mental Health, Melbourne Brain Centre; 🇦🇺 Heidelberg, Victoria, Australia