Self Treatment With an Electronic Device for Cognitive Rehabilitation in Patients With Subacute Stroke: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Trail Making Test Part A (TMT-A)
研究概览
简要总结
The objective of this study is to evaluate whether the independent use of an electronic device by a patient with stroke outcomes can enhance the effectiveness of rehabilitative treatment for attentional functions compared to standard treatment.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ischemic or hemorrhagic stroke
- •Within 2 weeks since stroke onset
- •Age under 85 years
- •Attention deficits as measured by the Trails task or the Broken Hearts subtest in the Oxford Cognitive Screen (OCS)
排除标准
- •Visual impairment documented by clinical history (e.g., cataracts, diabetic retinopathy, glaucoma, hemianopia)
- •Uncompensated psychiatric disorders
- •Drug or alcohol abuse
- •History of dementia
- •Severe comprehension disorders as determined by the Semantics subtest in the Oxford Cognitive Screen (OCS)
- •Spatial neglect as determined by the Broken Hearts subtest in the OCS
研究组 & 干预措施
Rehabilitation with a computerized device
Every morning both groups received the same face-to-face cognitive treatment using an electronic device. in the afternoon only the experimental group performed self-treatment with the same device for 2 weeks, 5 sessions a week, for a total of 10 sessions.
干预措施: Rehabilitation with a computerized device (in the morning) (Device)
Rehabilitation with a computerized device
Every morning both groups received the same face-to-face cognitive treatment using an electronic device. in the afternoon only the experimental group performed self-treatment with the same device for 2 weeks, 5 sessions a week, for a total of 10 sessions.
干预措施: Self-treatment with a computerized device (in the afternoon) (Device)
Rehabilitation with pencil-and-paper exercises
Every morning both groups received the same face-to-face cognitive treatment using an electronic device. Only the control group performed self-treatment with paper-and-pencil exercises for 2 weeks, 5 sessions a week, for a total of 10 sessions.
结局指标
主要结局
Trail Making Test Part A (TMT-A)
时间窗: From enrollment (within 2 weeks of stroke onset) to the completion of treatment (2 weeks after the start of treatment)
The Trail Making Test Part A (TMT-A) is a neuropsychological assessment that measures selective attention and processing speed. Participants connect a series of numbered circles in sequential order as quickly as possible. The score is determined by the time taken to complete the task, with shorter times indicating better performance. Errors may negatively impact the score.
次要结局
- Trail Making Test Part B (TMT-B)(From enrollment (within 2 weeks of stroke onset) to the completion of treatment (2 weeks after the start of treatment))
- Dual task test(From enrollment (within 2 weeks of stroke onset) to the completion of treatment (2 weeks after the start of treatment))
- short version of the Elithorn's Perceptual Maze Test(From enrollment (within 2 weeks of stroke onset) to the completion of treatment (2 weeks after the start of treatment))
- Stroop Test(From enrollment (within 2 weeks of stroke onset) to the completion of treatment (2 weeks after the start of treatment))
研究者
Valentina Varalta
Doctor
Universita di Verona