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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Taiwan
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
RECRUITING
New Taipei City
Taipei Tzu Chi Hospital
NOT_YET_RECRUITING
New Taipei City
National Taiwan University Hospital
NOT_YET_RECRUITING
Taipei
Taipei Medical University Hospital
RECRUITING
Taipei
Taipei Municipal Wanfang Hospital
RECRUITING
Taipei
Contact Information
Primary
Chang, ScD
ipc@tmu.edu.tw
+886-2-66202589
Time Frame
Start Date: 2025-01-17
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 261
Treatments
Experimental: Caregiver-Assisted Rehabilitation with Strategy Training (CAR-ST)
Trained therapists visit each participant once or twice weekly for 60 minutes. The program consists of 10 therapist-guided sessions over a maximum of 6 weeks and includes the following active ingredients: self-selected activity-based goals, dynamic performance analysis, global strategy (Goal-PlanDo-Check), massed practice, variable practice, increasing task difficulty, explicit and implicit feedback, guided discovery, action observation, and social interaction.
Active_comparator: Strategy Training
Participants assigned to the ST group receive a protocol similar to CAR-ST, with the distinction that their caregivers are not asked to co-participate in the intervention, and they are not instructed (by the research therapist) to provide assistance during at-home practice.
Placebo_comparator: Education
In this arm, participants receive a dose-matched intervention with 10 visits by well-trained research therapists through face-to-face talks (primary approach), video conference, or telephone calls. Sessions focus on instruction on general information regarding stroke and rehabilitation, and a summary of participants' condition and progression is provided for each visit.
Related Therapeutic Areas
Sponsors
Leads: Taipei Medical University

This content was sourced from clinicaltrials.gov