Investigation of disabilities following stroke in Taiwan

Taiwan Post-Stroke Disability Study (T-PODS): A Survey of Multiple Post-Stroke Disability Domains Among Stroke Patients in Taiwan

This study is looking at how many people have disabilities after a stroke and what might cause them, by following 2,000 stroke patients in Taiwan over a year.

Quick facts

• Study type: Observational
• Enrollment: 2000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: National Taiwan University Hospital (Academic / other)
• Locations: 1 site (Taipei)
• Trial ID: NCT06772194 on ClinicalTrials.gov

What this trial studies

This observational study aims to enroll 2,000 acute stroke patients from 14 medical centers across Taiwan to investigate the prevalence and risk factors of post-stroke disabilities. Data will be collected at three key points: at enrollment, three months, and twelve months post-stroke, using various assessments including surveys, imaging, and blood samples. The study focuses on understanding long-term changes in motor function, cognition, depression, and epilepsy among stroke survivors. By analyzing these factors, the study seeks to reduce the health burden of stroke in Taiwan.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have experienced an ischemic or hemorrhagic stroke and have a pre-stroke modified Rankin Scale score of 0, 1, or 2.

Not a fit: Patients with transient ischemic attacks, severe psychiatric disorders, or those unable to communicate due to severe aphasia may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved post-stroke care and interventions that enhance the quality of life for stroke survivors.

How similar studies have performed: Other studies have shown success in investigating post-stroke disabilities, but this specific approach focusing on a comprehensive assessment in the Taiwanese population is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Ischemic stroke confirmed by MRI, or hemorrhagic stroke diagnosed by CT or MRI.
2. Age ≥ 18 years.
3. Pre-stroke modified Rankin Scale (mRS) score of 0, 1, or 2.
4. Post-stroke mRS score of 0, 1, 2, 3, or 4 at enrollment.
5. Able to undergo cognitive function screening and other scale assessments within 30 days post-stroke.

Exclusion Criteria:

1. Transient ischemic stroke and subarachnoid hemorrhage.
2. Clear and severe psychiatric or emotional disorders before the stroke, including schizophrenia, major depressive disorder, and bipolar disorder.
3. History of clinical stroke within three months prior to enrollment.
4. Unable to communicate or cooperate for assessments due to severe aphasia.
5. Severe dementia prior to the stroke.
6. Pre-stroke modified Rankin Scale (mRS) score ≥ 3.
7. Post-stroke mRS score of 5 at enrollment.
8. History of cancer with an expected life expectancy of less than one year.
9. Expected life expectancy of less than one year due to other medical conditions.
10. Anticipated inability to complete a one-year follow-up.
11. Other situations deemed unsuitable for enrollment by the clinical investigator.

Where this trial is running

Taipei

• National Taiwan University Hospital, Taipei, — Taipei, Taiwan (Recruiting)

Study contacts

• Study coordinator: Chih-Hao Chen, Dotoral

Conditions Stroke; Dementia; Epilepsy; Depression; post stroke care; Acute stroke; swallowing; vascular dementia