Clinical trial NCT06754566: A Caregiver-Assisted Rehabilitation With Strategy Training (CAR-ST) for Stroke Patients
Official title: A Caregiver-Assisted Rehabilitation With Strategy Training (CAR-ST) for Stroke Patients With Functional Limitations: A MultiCenter, 3-Arm Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Stroke
Caregiver-assisted rehabilitation
Strategy training
Activity limitations
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2025-01-01
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Stroke is the leading cause of enduring disability worldwide, contributing to widespread impairments in survivors, thereby impeding various activities of daily life. Despite the effectiveness of intensive inpatient rehabilitation in mitigating deficits and activity limitations, maintaining an optimal treatment dose for patients transitioning to home remains a challenge. To address this gap, the integration of caregivers into home-based, evidence-supported rehabilitation emerges as a promising approach, yet its efficacy requires comprehensive examination. This clinical trial aims to assess the efficacy of a newly developed intervention, caregiver-assisted rehabilitation with strategy training (CAR-ST), in enhancing the activity performance of stroke survivors.

A single-blinded, three-arm randomized controlled trial will be executed, comparing the efficacy of the CAR-ST intervention against strategy training alone or attentional control through education. A procedure of randomization with minimization will be conducted by a researcher who is independent of the investigation and outcome assessments. Eligible stroke survivors and their caregivers will be recruited from collaborative hospitals in Northern Taiwan and randomly assigned with even possibility. Longitudinal evaluations will be conducted at baseline (T1), post-intervention (T2), 3-month (T3), and 6-month (T4) follow-ups, utilizing the Activity Measure for Post-Acute Care (AM-PAC) outpatient shortform as the primary outcome. Secondary outcomes will include the Participation Measure-3 Domains, 4 Dimensions (PM-3D4D), EuroQol-5D (EQ-5D), Stroke Self-Efficacy Questionnaires (SSEQ), Fugl-Meyer Assessment (FMA), Montreal Cognitive Assessment (MoCA), and Goal Attainment Scaling (GAS). Under the principles of modified intention-to-treat, quantitative data will be analyzed using multiple linear regression models and mixed-effects regression models. If data is lost at follow-up, inferential statistical analyses for group comparisons will be conducted both with or without multiple imputation. Furthermore, qualitative in-depth interviews with participants, caregivers, and therapists will be conducted post-intervention. These interviews will explore experiences, satisfaction, and perceived effectiveness of the intervention. Transcribed data will undergo coding by two independent coders and subsequent analysis through the thematic analysis method.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Activity Measure for Post-Acute Care (AM-PAC) Outpatient Short Forms
timeFrame: 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:
measure: Participation Measure-3 Domains, 4 Dimensions (PM-3D4D)
timeFrame: 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)
measure: EuroQol-5D-3L (EQ-5D-3L)
timeFrame: 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)
measure: Stroke Self-Efficacy Questionnaires (SSEQ)
timeFrame: 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)
measure: Fugl-Meyer Motor Assessment (FMA)
timeFrame: 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)
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 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)
measure: Goal Attainment Scale (GAS)
timeFrame: 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:
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: At baseline, within 4 weeks after enrollment
measure: modified Rankin Scale (mRS)
timeFrame: 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)
measure: Berg Balance Scale (BBS)
timeFrame: At baseline, within 4 weeks after enrollment
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: At baseline, within 4 weeks after enrollment
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Tzu Chi Hospital
city: New Taipei City
country: Taiwan
facility: Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei City
country: Taiwan
facility: Taipei Medical University Hospital
city: Taipei City
country: Taiwan
facility: Taipei Municipal Wanfang Hospital
Study officials:
affiliation: Graduate Institute of Injury Prevention and Control, Taipei Medical University
name: Feng-Heng Chang, ScD
role: PRINCIPAL_INVESTIGATOR
References: