Actively Recruiting
Caregiver-Assisted Rehabilitation With Strategy Training for Stroke Patients With Functional Limitations A Multi-Center 3-Arm Randomized Trial
Led by Taipei Medical University · Updated on 2025-02-17
261
Participants Needed
5
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of involving caregivers in a rehabilitation approach called caregiver-assisted rehabilitation with strategy training (CAR-ST) to improve daily activity functions in adults who have had a stroke. The study aims to compare CAR-ST with strategy training alone and with an education program to see which approach leads to better improvements in activity performance and whether these improvements extend to other areas like participation and impairment. This is a single-blinded, three-arm randomized controlled trial conducted in multiple centers to assess the potential benefits of caregiver involvement in home-based post-stroke rehabilitation. Participants will be randomly assigned to one of three groups: CAR-ST, strategy training alone, or an education program. The CAR-ST and strategy training groups receive up to 10 therapist-guided sessions over a maximum of 6 weeks, with sessions once or twice weekly lasting about 60 minutes each. CAR-ST involves caregivers actively assisting and motivating participants during at-home practice, while the strategy training group does not include caregiver participation. The education group receives 10 matched sessions focused on stroke information delivered through face-to-face talks, video calls, or phone calls. During the study, participants will be assessed at four time points: before treatment, immediately after the intervention, and at 3- and 6-month follow-ups. Researchers will use various clinical tools to measure changes in activity performance, participation, quality of life, self-efficacy, motor function, cognition, and goal attainment. Qualitative interviews will also explore participant and caregiver experiences and satisfaction. The total involvement spans from baseline through six months after treatment, with continuous monitoring and data analysis to evaluate the interventions' impact.
CONDITIONS
Brief Title
A Caregiver-Assisted Rehabilitation With Strategy Training (CAR-ST) for Stroke Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to provide informed consent
- Diagnosed with ischemic and/or hemorrhagic stroke
- Modified Rankin Scale score between 2 and 4
- Rehabilitation frequency less than 3 days per week
- Having a healthy caregiver
You will not qualify if you...
- Receiving palliative care
- Having major diseases or severe conditions affecting participation, such as global aphasia, dementia, multiple organ failure, or immobilization due to fracture
- Moderate post-stroke cognitive impairment with Montreal Cognitive Assessment score below 22
- Pre-stroke Modified Rankin Scale score greater than 1
- Currently participating in another interventional study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks
Participants receive one of three home-based rehabilitation interventions guided by trained therapists for up to 6 weeks. This includes 10 therapist-guided sessions with visits occurring once or twice weekly for 60 minutes, focusing on strategy training with or without caregiver involvement or education about stroke.
10 visits over up to 6 weeks
Duration - 6 months after treatment
Participants are evaluated at 3 months and 6 months after the end of the intervention to assess ongoing outcomes and effectiveness of the rehabilitation.
2 follow-up visits at 3 and 6 months
Trial Site Locations
Total: 5 locations
1
Taipei Tzu Chi Hospital
New Taipei City, Taiwan, 231
Not Yet Recruiting
2
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
New Taipei City, Taiwan, 235
Actively Recruiting
3
National Taiwan University Hospital
Taipei, Taiwan, 100
Not Yet Recruiting
4
Taipei Medical University Hospital
Taipei, Taiwan, 110
Actively Recruiting
5
Taipei Municipal Wanfang Hospital
Taipei, Taiwan, 116
Actively Recruiting
Research Team
C
Chang, ScD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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