NCT03864484Unknown不适用
An iPad Application-based Intervention for Improving Post-stroke Depression Symptoms: A Pilot Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Depression severity as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) score.
研究概览
简要总结
We plan to conduct a randomized controlled trial to examine whether usual rehabilitation plus an iPad application-based intervention improves post-stroke depression symptoms compared to usual rehabilitation alone.
The purpose of this pilot randomized controlled trial is to investigate the feasibility of the final randomized controlled trial.
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
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40 years and older
- •Males and females
- •Center for Epidemiologic Studies Depression Scale score ≥16
- •Mini Mental State Examination score ≥ 24
- •First stroke
- •Native language is Japanese
- •Written informed consent prior to participation
排除标准
- •Major depressive disorder before onset of stroke
- •Bilateral hemiplegia
- •Vision or hearing deficits that negatively impact everyday life
- •Severe aphasia
- •Severe unilateral spatial neglect
- •Diagnosis of neurodegenerative disease such as Parkinson's disease or multiple system atrophy
- •Current life-threatening severe organ failure, musculoskeletal disorders, or cancer
结局指标
主要结局
Depression severity as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) score.
时间窗: Change from Baseline CES-D at 5 weeks
次要结局
- Activities of daily living as measured by Functional Independence Measure (FIM).(Change from Baseline FIM at 5 weeks)
- Safety is defined as the proportion of patients who experience an intervention-related adverse event or any adverse event during the study.(The period from the start of the intervention to 5 weeks)
- Dynamic standing balance as measured by Functional Reach Test (FRT).(Change from Baseline FRT at 5 weeks)
- Health-related quality of life as measured by the 36-item short-form Medical Outcome Study Questionnaire (SF-36).(Change from Baseline SF-36 at 5 weeks)
研究者
Kazuki Hirao, PhD, OT
Assistant Professor
Kibi International University
研究点 (2)
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