About this trial

The goal of this study is to examine the feasibility of delivering an innovative intervention, caregiver-assisted strategy training (CaST), targeting enhancing activity functions in community-dwelling adults after stroke. The main questions it aims to answer are:

* Is CaST acceptable to stroke survivors with functional limitations? * Does CaST show positive effects on functional outcomes?

Researchers will compare the CaST program to a control education program to investigate the interventional effect size for the selected stroke participants.

Participants will:

* Receive CAST 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. * Be interviewed once after finishing their intervention.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Participating in other interventional study concurrently.

Trial design

Design model

Parallel

Treatments tested in this trial

Caregiver-Assist Strategy Training
Behavioral
CaST is a home-based rehabilitation that guides both stroke survivors and their caregivers to implement strategy training for addressing real-life limitations after stroke. During the intervention, the caregiver not only supervises the participant but also co-participates in the practice by instructing on when and how to be an assistant and facilitator when the stroke survivor executes their practice plan.
Education
Behavioral
Stroke-related information and knowledge that includes stroke subtypes and their etiology, risk factors of primary and secondary stroke, healthy lifestyles, common sequela, and adaptive skills for impaired functions are provided.

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Caregiver-Assisted Strategy TrainingExperimental treatment 1 intervention

Group B: EducationSham 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. We determine the AM-PAC as the primary outcome due to its effect size from the between-group comparison will be used in developing the further efficacy trial.

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 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

Time frame

At baseline, within 4 weeks after enrollment

2

Berg Balance Scale (BBS)

BBS is used to indicate participants' balance function before intervention

Time frame

At baseline, within 4 weeks after enrollment

3

Hospital Anxiety and Depression Scale (HADS)

HADS is used to indicate participants' mood status before intervention

Time frame

At baseline, within 4 weeks after enrollment

4

modified Rankin Scale (mRS)

mRS is used to indicate participants' global disability

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)

Feasibility Study of Caregiver-Assist Strategy Training

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts