Caregiver-assisted rehabilitation for stroke patients
A Caregiver-Assisted Rehabilitation With Strategy Training (CAR-ST) for Stroke Patients With Functional Limitations: A MultiCenter, 3-Arm Randomized Trial
This study tests whether involving caregivers in rehabilitation helps stroke survivors improve their daily activities better than standard treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 261 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Taipei Medical University Academic / other |
| Locations | 5 sites (New Taipei City and 4 other locations) |
| Trial ID | NCT06754566 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of caregiver-assisted rehabilitation with strategy training (CAR-ST) for improving activity functions in stroke survivors. Participants will be randomly assigned to receive either CAR-ST, strategy training alone, or an education program. The study aims to determine if involving caregivers enhances the rehabilitation outcomes compared to standard approaches. Evaluations will occur at multiple time points to assess the impact on activity performance and overall functional improvements.
Who should consider this trial
Good fit: Ideal candidates include community-dwelling adults diagnosed with ischemic or hemorrhagic stroke who have a modified Rankin Scale score between 2 and 4.
Not a fit: Patients receiving palliative care or those with severe cognitive impairments or other major health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the rehabilitation outcomes for stroke survivors, leading to improved daily functioning.
How similar studies have performed: While caregiver involvement in rehabilitation is a promising approach, the specific CAR-ST intervention is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Being willing to provide informed consent * Diagnosis with ischemic and/or hemorrhagic stroke * Modified Rankin Scale (mRS) ranges from 2 to 4 * Rehabilitation frequency less than 3 days per week * Having a healthy caregiver Exclusion Criteria: * Undergoing palliative care * Major diseases or severe conditions influencing study participation, such as global aphasia, dementia, multiple organ failure, immobilization due to fracture, etc * Moderate post-stroke cognitive impairment, with Montreal Cognitive Assessment score \<22 * Pre-stroke mRS \> 1 * Participating in other interventional study concurrently.
Where this trial is running
New Taipei City and 4 other locations
- Taipei Tzu Chi Hospital — New Taipei City, Taiwan (Not_yet_recruiting)
- Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare — New Taipei City, Taiwan (Recruiting)
- National Taiwan University Hospital — Taipei, Taiwan (Not_yet_recruiting)
- Taipei Medical University Hospital — Taipei, Taiwan (Recruiting)
- Taipei Municipal Wanfang Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Principal investigator: Feng-Heng Chang, ScD — Graduate Institute of Injury Prevention and Control, Taipei Medical University
- Study coordinator: Chang, ScD
- Email: ipc@tmu.edu.tw
- Phone: +886-2-66202589
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.