Centering Emotional Recovery Post-Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Warwick-Edinburgh Mental Wellbeing Scale (WEMWS)
研究概览
简要总结
The purpose of this study is to evaluate whether adding an emotional wellness component to occupational therapy (OT) and/or speech therapy (ST) telerehabilitation improves overall emotional well-being and activity participation for people with stroke.
详细描述
The purpose of this study is to evaluate whether adding an emotional wellness component to occupational therapy (OT) and/or speech therapy (ST) telerehabilitation improves overall emotional well-being and activity participation for people with stroke. Participants will complete 9 telerehabilitation therapy sessions over 8 weeks. These sessions will take place over a video visit using a personal device (phone, tablet, or computer). Each session will last about 1 hour. Sessions will focus on occupational therapy and/or speech therapy depending on the participant's stroke-related movement and/or language deficits. Each study participant will be randomly assigned to one of two intervention groups. Both groups will include OT or ST; however, one group will include an emotional wellness component using a modified version of Cognitive Behavioral Therapy. Participants will also complete 2 assessment visits, one before the telerehabilitation begins and one after the telerehabilitation program ends. The assessment visits will also take place via a video visit using a personal device. Assessments include measures of emotional well-being, quality of life, activity engagement, arm/hand movement, communication/language skills, balance, and ability to perform daily activities.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-reported stroke-related deficits in emotional wellness such as anxiety, sleep disturbance, dread, fear, loss of hope, sadness.
- •Have experienced ischemic or hemorrhagic stroke at least 30 days prior
- •Stroke-related aphasia and/or upper extremity hemiparesis
- •Aged 21 years or older
- •English as primary language
- •Have corrected vision to be able to read text on a screen
- •Able to participate fully in the study's tele-rehabilitation (Aim 1) and/or virtual group programing (Aim 2) with personally owned device (i.e., phone, tablet, or laptop) and personal Wi-Fi connection or cellular service
- •Cognitive, language, and motor capacity to participate fully in the study's assessment session as per the judgment of the licensed, experienced stroke tele-rehabilitation occupational or speech therapist
排除标准
- •Unable to follow 1-2 step instructions given by the study team member during the informed consent procedures.
- •Pain that interferes with ability to participate in the study's upper extremity movement tasks.
- •Have impaired decision making capacity as determined by the U-ARE protocol for assessing capacity to provide informed consent.
研究组 & 干预措施
modified Cognitive Behavioral Therapy + Telerehabilitation Occupational or Speech Therapy
干预措施: modified Cognitive Behavioral Therapy (mCBT) (Behavioral)
modified Cognitive Behavioral Therapy + Telerehabilitation Occupational or Speech Therapy
干预措施: Occupational or Speech Therapy (Behavioral)
Telerehabilitation Occupational or Speech Therapy
干预措施: Occupational or Speech Therapy (Behavioral)
结局指标
主要结局
Warwick-Edinburgh Mental Wellbeing Scale (WEMWS)
时间窗: Baseline, pre-intervention and immediately after the intervention, Week 8.
14-item scale of mental well-being rated by participants on a 5-point scale (1=low, 5=high). Summed item ratings are reported out of 70 points so that higher scores indicate greater mental wellbeing.
Patient Specific Functional Scale (PSFS)
时间窗: Baseline, pre-intervention and immediately after the intervention, Week 8.
A patient-reported measure of task-goal identification and difficulty performing the task on a 0-10-point ordinal scale with higher ratings indicating greater satisfaction with task performance.
Stroke and Aphasia Quality of Life Scale (SAQoL)
时间窗: Baseline, pre-intervention and immediately after the intervention, Week 8.
39-item stroke-specific measure of health-related quality of life rated by participants on a 5-point scale (1 = couldn't do it at all, 5 = no trouble at all). An overall mean score is computed as well as three domain scores: physical, communication, and psychosocial. Higher scores indicate better quality of life.
次要结局
未报告次要终点
研究者
Michelle Woodbury
Professor-Faculty
Medical University of South Carolina