Establishment of Virtual Reality System for Stroke Patients With Aphasia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Changes Concise Chinese Aphasia Test (CCAT) scores at 1 day after treatment
研究概览
简要总结
Aphasia can significantly influence a person's social relationship and quality of life. To achieve positive language outcomes, an intensive and high-repetition speech therapy is essential. However, due to the limited number of speech therapists, the intensity and frequency of training are often insufficient. Therefore, it is critical to develop other rehabilitation approaches to enhance the benefits of aphasia intervention. Virtual reality (VR) is an immersive and interactive computer simulation technology that can promote the ecological validity of speech therapy. In this study, we develop an innovative VR software for speech training to explore the effects of VR on various aspects of language outcomes.
详细描述
We randomly assigned study participants into 2 groups: the traditional speech therapy (ST) group and the traditional ST with additional VR training (ST+VR) group. In the ST group, each participant received 1-hour traditional ST for each session. In the ST+VR group, an additional 30-minute VR training was administered immediately after each session of traditional ST. All participants received 3 sessions of treatment every week for 3 weeks. For outcome measurement, we administered Concise Chinese Aphasia Test (CCAT) at 3 different time points: before treatment, 1 day and 3 months after the completion of 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 (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of stroke with aphasia, including fluent and non-fluent types
- •Age between 20~80-year-old
- •Able to understand virtual reality training
- •Able to cooperate with instructions and follow the rules
- •Able to use the virtual reality controller and device
- •Able to sign the subject's informed consent
排除标准
- •Diagnosis of brain pathology other than stoke, such as brain tumor, Parkinson's disease, dementia
- •Unable to cooperate with the instructions
- •Unable to learn how to use the virtual reality controller and device
- •Any medical diseases or unstable vital signs that may cause safety concern
- •Severe hearing or vision impairments
- •Have ever received any form of speech therapy or virtual reality training
研究组 & 干预措施
traditional speech therapy and additional virtual reality training group
Each participant received 1-hour traditional speech therapy(ST) and additional 30-minute VR training immediately after each session of traditional ST. All participants received 3 sessions of treatment every week for 3 weeks.
干预措施: virtual reality speech training (Other)
traditional speech therapy and additional virtual reality training group
Each participant received 1-hour traditional speech therapy(ST) and additional 30-minute VR training immediately after each session of traditional ST. All participants received 3 sessions of treatment every week for 3 weeks.
干预措施: traditional speech therapy (Other)
traditional speech therapy group
Each participant received 1-hour traditional speech therapy(ST) only for each session. All participants received 3 sessions of treatment every week for 3 weeks.
干预措施: traditional speech therapy (Other)
结局指标
主要结局
Changes Concise Chinese Aphasia Test (CCAT) scores at 1 day after treatment
时间窗: Baseline and at 1 day after total treatments complete
CCAT total scores and scores of subtests, including conversation, description, matching, listening comprehension, expression, reading recognition, sentence repetition, imitation, spontaneous writing
Changes of Concise Chinese Aphasia Test (CCAT) scores at 3 months after treatment
时间窗: Baseline and at 3 months after total treatments complete
CCAT total scores and scores of subtests, including conversation, description, matching, listening comprehension, expression, reading recognition, sentence repetition, imitation, spontaneous writing
次要结局
未报告次要终点