The Impact of Using an Interactive System, a Paper and Pencil Program or Conventional Methodologies in the Rehabilitation of Stroke Patients: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Change from baseline in the Montreal Cognitive Assessment
研究概览
简要总结
Virtual Reality allows the integration of both cognitive and motor rehabilitation in a more ecologically valid context. The purpose of this study is to determine whether this methodology has more impact on stroke rehabilitation than a paper and pencil personalised program and conventional therapy, which is motor-focused.
详细描述
Cognitive impairments after stroke are not always given sufficient attention despite its limitations in activities-of-daily- living (ADL's). Current cognitive rehabilitation methods mostly rely on paper-and-pencil tasks targeting isolated domains, which is not consistent with everyday-life. Besides limited ecological-validity, paper-and-pencil tasks are not accessible for most stroke patients whose dominant arm is paretic. Virtual Reality (VR) has shown to be a solution for the development of accessible and ecologically valid systems, but, does it have more impact than a paper and pencil personalised intervention?
Through a participatory design approach, with health professionals, the investigators have developed:
- a motor-accessible and cognitive-personalized VR-based system, where conventional cognitive tasks were operationalized in meaningful simulations of ADL's (Reh@City) and;
- a web tool which generates personalised paper and pencil tasks( Task Generator).
The investigators objective is to have a sample of 60 stroke patients between 40 and 70 years old, randomly allocated in three groups: the experimental group 1 were participants will perform 30 minutes of the VR training with Reh@City; the experimental group 2 were participants will perform 30 minutes of the paper and pencil training with the Task Generator, and the control group were participants will perform 30 minutes of conventional therapy (occupational therapy).
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ischemic stroke with more than 6 months post-stroke
- •cognitive deficit but with enough capacity to understand the task and follow instructions with a minimum score of 11 over 17 in the Token Test (6-item version, Portuguese population)
- •able to read and write
排除标准
- •Severe depressive symptoms as assessed by the Beck Depression Inventory
研究组 & 干预措施
Virtual Reality
The Virtual Reality group will perform personalised activities of daily living in the context of a simulated city (Reh@City). The interaction with the virtual environment will be through a natural user interface.
干预措施: Virtual Reality (Procedure)
Paper and Pencil
The paper and pencil group will perform a set of cognitive paper and pencil tasks personalised to their deficits and generated automatically through a Task Generator.
干预措施: Paper and Pencil (Procedure)
Conventional Therapy
The Conventional Therapy group will perform the activities offered by the public health system, which are motor-focused.
干预措施: Conventional Therapy (Procedure)
结局指标
主要结局
Change from baseline in the Montreal Cognitive Assessment
时间窗: Baseline, End (4-6 weeks) and 8-weeks follow-up
次要结局
- Change from baseline in the Trail Making Test A and B(Baseline, End (4-6 weeks) and 8-weeks follow-up)
- Change from baseline in the Verbal Paired Associates (WMS III)(Baseline, End (4-6 weeks) and 8-weeks follow-up)
- Change from baseline in the Digit Span (WAIS III)(Baseline, End (4-6 weeks) and 8-weeks follow-up)
- Change from baseline in the Symbol Search and Coding (WAIS III)(Baseline, End (4-6 weeks) and 8-weeks follow-up)
研究者
Sergi Bermúdez i Badia
Professor Auxiliar
Universidade da Madeira