RecruitingNot ApplicableNCT06754566

A Caregiver-Assisted Rehabilitation With Strategy Training (CAR-ST) for Stroke Patients

A Caregiver-Assisted Rehabilitation With Strategy Training (CAR-ST) for Stroke Patients With Functional Limitations: A MultiCenter, 3-Arm Randomized Trial


Sponsor

Taipei Medical University

Enrollment

261 participants

Start Date

Jan 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this randomized controlled trial is to examine if involving the caregivers in the strategy training (i.e. caregiver-assisted rehabilitation with strategy training, CAR-ST) works to improve activity functions in community-dwelling adults after stroke. The main questions it aims to answer are: Does CAR-ST and strategy training alone lead to greater improvements in activity performance among stroke survivors relative to the control intervention with education? Does CAR-ST outperform strategy training alone in the efficacy of activity outcomes? Do the activity effects of CAR-ST transfer to the impairment and participation domains of outcomes? Researchers will compare the efficacy of the CAR-ST intervention against strategy training alone or control intervention (education program) to see if caregivers contribute to post-stroke functional improvements. Participants will: * receive CAR-ST, strategy training only, or an education program 1 to 2 sessions per week until finishing 10 sessions. * be assessed clinical outcomes at 4 times: pre-intervention, post-intervention, 3-month, and 6-month follow-up.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria5

  • 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.

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Interventions

BEHAVIORALCaregiver-Assisted Rehabilitation with Strategy Training

CAR-ST is a home-based rehabilitation that guides both stroke survivors and their caregivers to implement strategy training for addressing daily activity limitations after stroke. The caregiver, as an active partner, not only supervises the participant but also co-participates in the practice. Caregivers are instructed on when and how to provide assistance during task practice, using physical, verbal, or visual guidance. As the participant's performance improves, the caregiver is empowered to motivate them to exert greater efforts, encouraging higher repetitions, longer durations of the same task, and an increased level of difficulty.

BEHAVIORALStrategy Training

Compared to CAR-ST, ST is a home-based rehabilitation that guides stroke survivors only to implement strategy training for addressing daily activity limitations after stroke.

BEHAVIORALEducation

Stroke-related information and knowledge that includes stroke subtypes and their etiology, risk factors of primary and secondary stroke, healthy lifestyles, common sequala, and adaptive skills for impaired functions are provided.


Locations(5)

Taipei Tzu Chi Hospital

New Taipei City, Taiwan

Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

New Taipei City, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Medical University Hospital

Taipei, Taiwan

Taipei Municipal Wanfang Hospital

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

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NCT06754566


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