RehaCom Memory Modules in Moderate-to-severe Traumatic Brain Injury (TBI)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) - Story Memory performance
研究概览
简要总结
The purpose of this research study is to evaluate the effectiveness of "RehaCom," a computerized treatment for memory deficits, in a 16-session, interactive course. Following a manualized approach, the Rehacom modules will be used for the repeated application of the content acquired during 1-on-1 memory strategy training. The goal is to improve face/name, list and verbal memory of patients who survived a moderate to severe traumatic brain injury.
详细描述
This randomized clinical trial (RCT) consists of 20 chronic moderate-to-severe TBI patients who will receive memory strategy training and complete three memory modules of the RehaCom at one of the Kessler Foundation locations. Changes in attention, processing speed, verbal/non-verbal new learning and memory (NLM) and executive control will be assessed via pre/post and 3-month follow-up assessments before and after the 8-10 week intervention. Self-report questionnaires will also track functional and emotional outcomes such as mood and anxiety, cognition, quality of life, self-efficacy, deficit awareness, community participation, and readiness for occupational functioning
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 (Participant, Outcomes Assessor)
盲法说明
Group assignments will be concealed and assessments and interventions will be conducted by trained staff blinded to each other's findings and data.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to read and speak English fluently at the 5th grade level (for testing; software has multilingual support)
- •Had a TBI at least 1 year ago
- •No history of learning disorders during school years
- •Able to use a personal computer (PC) non-stop for 1 hour without health or visual complaints; able to press keyboard buttons.No history of learning disorders
排除标准
- •Actively participating in another intervention study
- •Distance to Kessler Foundation East Hanover or West Orange location is more than 20 miles.
结局指标
主要结局
Change in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) - Story Memory performance
时间窗: baseline & 10-14 weeks after baseline assessment
Raw scores from Story A and Story B recall \[0-50\], where higher scores indicate better recall.
Change in Wechsler Memory Scale III - Faces II performance
时间窗: baseline & 10-14 weeks after baseline assessment
Delayed Recall Score \[0-48\] where higher scores indicate better recall.
Change in California Verbal Learning Test - II (CVLT-II) performance
时间窗: Baseline & 10-14 weeks after baseline assessment
We will use the raw scores for free and cued delayed recall \[0-16\] where higher scores indicate better verbal recall.
次要结局
未报告次要终点