A Caregiver-Assisted Rehabilitation With Strategy Training (CAR-ST) for Stroke Patients
ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTaipei Medical University
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Caregiver-Assisted Rehabilitation with Strategy Training
BehavioralCAR-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.
Strategy Training
BehavioralCompared 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.
Education
BehavioralStroke-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.
Treatment groups
261 Participants
are divided into 3 treatment groupsGroup A: Caregiver-Assisted Rehabilitation with Strategy Training (CAR-ST)Experimental treatment 1 intervention
Group B: Strategy TrainingActive comparator 1 intervention
Group C: EducationPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Activity Measure for Post-Acute Care (AM-PAC) Outpatient Short Forms
The AM-PAC measures the difficulty is performing three activity domains: Basic Mobility (18 activities), Daily Activity (15 activities), and Applied Cognition (19 activities) on a 4-point scale. In this trial, Applied Cognition domain is viewed as a secondary outcome. A trained research assistant performs AM-PAC face-to-face with participants.
Time frame
4 time points: baseline (T1), from baseline to the end of intervention at 5-10 weeks (T2), from the end of intervention to 3-month follow-up (T3), from the end of intervention to 6-month follow-up (T4)Secondary outcomes
1
Participation Measure-3 Domains, 4 Dimensions (PM-3D4D)
PM-3D4D consists of 24 items for evaluating three domains of participation, which are community, productivity, and social. Participants will be asked to rate all items on the four distinct dimensions: (1) diversity, (2) frequency, (3) desire for change, and (4) perceived difficulty. A trained research assistant performs PM-3D4D face-to-face with participants.
Time frame
4 time points: baseline (T1), from baseline to the end of intervention at 5-10 weeks (T2), from the end of intervention to 3-month follow-up (T3), from the end of intervention to 6-month follow-up (T4)2
EuroQol-5D-3L (EQ-5D-3L)
EuroQol-5D-3L (EQ-5D-3L) is a self-reported measurement that assesses participants' health-related quality of life across five domains: mobility, self-care, usual activity, pain/discomfort, anxiety/depression. In each domain, the assessment utilizes three levels to indicate the extent of problem: no problem, moderate problems, and extreme problems. A trained research assistant performs EQ-5D-3L face-to-face with participants.
Time frame
4 time points: baseline (T1), from baseline to the end of intervention at 5-10 weeks (T2), from the end of intervention to 3-month follow-up (T3), from the end of intervention to 6-month follow-up (T4)3
Stroke Self-Efficacy Questionnaires (SSEQ)
SSEQ measures individual confidence in functional performance after stroke \[64\]. It contains 13 items, and each item is rated on a 10-point scalar from 0 (not at all confident) to 10 (very confident). A trained research assistant performs SSEQ face-to-face with participants.
Time frame
4 time points: baseline (T1), from baseline to the end of intervention at 5-10 weeks (T2), from the end of intervention to 3-month follow-up (T3), from the end of intervention to 6-month follow-up (T4)4
Fugl-Meyer Motor Assessment (FMA)
FMA measures the motor impairments of hemiplegia and includes a proximal subscale of upper extremity (0-42 points) for the shoulder/elbow/forearm, distal subscale of upper extremity (0-24 points) for the wrist/hand, and a lower extremity subscale (0-34 points) A trained research assistant performs FMA face-to-face with participants.
Time frame
4 time points: baseline (T1), from baseline to the end of intervention at 5-10 weeks (T2), from the end of intervention to 3-month follow-up (T3), from the end of intervention to 6-month follow-up (T4)Other outcomes
1
National Institutes of Health Stroke Scale (NIHSS)
NIHSS is used to indicate participants' stroke severity before intervention (range 0-42).
Time frame
At baseline, within 4 weeks after enrollment2
modified Rankin Scale (mRS)
mRS is used to indicate participants' global disability (0-6).
Time frame
4 time points: baseline (T1), from baseline to the end of intervention at 5-10 weeks (T2), from the end of intervention to 3-month follow-up (T3), from the end of intervention to 6-month follow-up (T4)3
Berg Balance Scale (BBS)
BBS is used to indicate participants' balance function before intervention (0-56).
Time frame
At baseline, within 4 weeks after enrollment4
Hospital Anxiety and Depression Scale (HADS)
HADS is used to indicate participants' mood status before intervention (0-21).
Time frame
At baseline, within 4 weeks after enrollmentSponsors and contacts
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Source ClinicalTrials.gov