Cognitive Oriented Strategy Training Augmented Rehabilitation (COSTAR) Treatment Approach for Stroke
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Canadian Occupational Performance Measure (COPM)
研究概览
简要总结
Stroke is the most serious disabling condition in the United States and the developed world. Novel stroke rehabilitation approaches, such as task-specific training, have shown promise in improving an individual's recovery in the rehabilitation setting; however, evidence suggests that these improvements are not generalized or transferred to the home, community, or work settings. Thus, these interventions usually do not impact overall health and participation outcomes. This research study seeks to improve task-specific training as a stroke rehabilitation approach by integrating it with evidence-based cognitive-oriented strategies which have shown great promise as a way to address the limitations of task-specific training. The new treatment protocol is called Cognitive-Oriented Strategy Training Augmented Rehabilitation, or COSTAR. The hypothesis of this study is that COSTAR will result in more efficient functional skill acquisition, better long-term retention of skills learned, and generalization and transfer of skills learned to home, community, and work settings.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 or older;
- •have completed all physician recommended rehabilitation and currently not receiving rehabilitation services;
- •at least one-month post-stroke;
- •have self-reported unmet functional goals; and
- •NIH Stroke Scale (NIHSS) total score of 2-12.
排除标准
- •have sustained a hemorrhagic stroke;
- •NIH Stroke Scale (NIHSS) aphasia rating of 1 or more (impaired speech);
- •MoCA cognitive screen score of less than 21 (impaired general cognitive ability);
- •neurological diagnoses other than stroke;
- •major psychiatric illness (bipolar disorder, OCD, panic disorder, PTSD, and/or borderline personality disorder);
- •no major depressive symptoms (PHQ-9 < 20);
- •a score of 6 or less on the CIHI aphasia screen combined items 64 and 66;
- •terminal illness;
- •blindness; and
- •non-English speaking.
研究组 & 干预措施
Task Specific Training (TST)
干预措施: Task Specific Training (TST) (Behavioral)
Cognitive-Oriented Strategy Augmented Rehabilitation (COSTAR)
干预措施: Cognitive-Oriented Strategy Augmented Rehabilitation (COSTAR) (Behavioral)
结局指标
主要结局
Canadian Occupational Performance Measure (COPM)
时间窗: Change from baseline to post-intervention (12 weeks)
Performance Quality Rating Scale (PQRS)
时间窗: Change from baseline to post-intervention (12 weeks)
次要结局
- Self-Efficacy Gauge (SEG)(Change from baseline to post-intervention (12 weeks))
- Activity Card Sort (ACS)(Change from baseline to post-intervention (12 weeks))
- Reintegration to Normal Living Index (RNLI)(Change from baseline to post-intervention (12 weeks))
- Stroke Impact Scale (SIS)(Change from baseline to post-intervention (12 weeks))
- Patient Reported Outcomes Measurement System (PROMIS-57)(Change from baseline to post-intervention (12 weeks))
- Patient Health Questionnaire (PHQ-9)(Change from baseline to post-intervention (12 weeks))