A Caregiver-Assisted Rehabilitation With Strategy Training (CAR-ST) for Stroke Patients With Functional Limitations: A MultiCenter, 3-Arm Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 261
- 试验地点
- 5
- 主要终点
- Activity Measure for Post-Acute Care (AM-PAC) Outpatient Short Forms
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
A researcher is responsible for the randomization process and the results are coded with predefined IDs that investigators and outcomes assessors are unaware of the meaning.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Caregiver-Assisted Rehabilitation with Strategy Training (Behavioral)
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.
干预措施: Strategy Training (Behavioral)
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.
干预措施: Education (Behavioral)
结局指标
主要结局
Activity Measure for Post-Acute Care (AM-PAC) Outpatient Short Forms
时间窗: 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)
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.
次要结局
- Participation Measure-3 Domains, 4 Dimensions (PM-3D4D)(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))
- EuroQol-5D-3L (EQ-5D-3L)(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))
- Stroke Self-Efficacy Questionnaires (SSEQ)(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))
- Fugl-Meyer Motor Assessment (FMA)(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))
- Montreal Cognitive Assessment (MoCA)(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))
- Goal Attainment Scale (GAS)(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))
研究者
Feng-Hang Chang
Professor
Taipei Medical University