Tele-rehabilitation for Cognitive Disorders: a Randomized Controlled Trial in Patients with Stroke Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Trail Making Test Part B (TMT-B)
研究概览
简要总结
The aim of the study is to evaluate whether a computer-based cognitive treatment delivered via tele-rehabilitation produces an improvement in cognitive functioning comparable to the improvement achievable through the same treatment delivered in person in patients with stroke outcomes.
To investigate, using a custom-designed questionnaire, the feasibility and patient satisfaction with the rehabilitative treatment delivered via telemedicine compared to the same treatment delivered in person.
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 90 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;
- •Age between 18 and 90 years;
- •First stroke event;
- •Stroke occurred more than 30 days ago;
- •Adequate level of understanding;
- •Presence of one or more of the following cognitive disorders:
- •Memory disorders
- •Attention disorders
- •Executive function disorders
- •Availability of an internet connection at the patient's home necessary for the telemedicine procedures.
排除标准
- •Presence of other neurological disorders;
- •Presence of pre-morbid cognitive decline;
- •Psychiatric disorders in the medical history;
- •Alcohol and/or drug abuse;
- •Presence of severe uncorrected visual deficits.
结局指标
主要结局
Trail Making Test Part B (TMT-B)
时间窗: From enrollment to the end of treatment and 2 months until the end of treatment
Used as a measure of attentional set-shifting and mental flexibility. Time needed to complete the tasks is recorded.
次要结局
- The Trail Making Test - A (TMT-A)(From enrollment to the end of treatment and 2 months until the end of treatment)
- 15 Words of Rey(From enrollment to the end of treatment and 2 months until the end of treatment)
- Memory with interference - ENB 2(From enrollment to the end of treatment and 2 months until the end of treatment)
- Functional Independence Measure (FIM)(From enrollment to the end of treatment and 2 months until the end of treatment)
- Hospital Anxiety and Depression Scale(From enrollment to the end of treatment and 2 months until the end of treatment)
- Short Form Health Survey 36 (SF-36)(From enrollment to the end of treatment and 2 months until the end of treatment)
- Feasibility, Satisfaction, and Cost Questionnaire(From enrollment to the end of treatment and 2 months until the end of treatment)
- Dual task test(From enrollment to the end of treatment and 2 months until the end of treatment)
- Elithorn's Perceptual Maze Test(From enrollment to the end of treatment and 2 months until the end of treatment)
- Stroop Test(From enrollment to the end of treatment and 2 months until the end of treatment)
研究者
Valentina Varalta
Doctor
Universita di Verona