Combining Immersive Virtual Reality With Telerehabilitation to Provide Language Intervention for People With Aphasia: A Randomized Waitlist Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Change in language abilities from baseline to week 9 and to week 18
研究概览
简要总结
The main purpose of this study is to evaluate the use of the immersive 3D HMD VR technology in the language intervention with a home-based telerehabilitation approach for people with aphasia. The assessments will be conducted at the baseline (prior the intervention periods) and after each intervention period (i.e. after the VR-intervention period and the waitlist period).
详细描述
The purpose of the present project is to study the effects, feasibility, and the participants' experiences of this novel kind of language intervention. The effects of the intervention will be studied with various outcome measures in terms of language performance, functional communication, and quality of life. The aim is to explore the VR-intervention on the group level and with a randomized waitlist control group design (or delayed crossover design). In this study, the people with aphasia will be practicing at their home with support of their relatives, and participants will also receive regular remote guidance by a speech and language therapist (SLT) during the intervention. The relatives are also involved in the assessment process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Post-stroke aphasia ≥ 3 months from stroke
- •Age 18-75 years
- •Finnish as a native language
- •Relative have the motivation and willingness to support person with aphasia in rehabilitation process
- •At least some level of spoken output
- •Moderate-to-severe aphasia
- •Deficit in a word retrieval process
排除标准
- •Participation in other intervention study during the study
- •Participation in other traditional speech and language therapy during the VR-intervention (i.e. 9-10 weeks period).
- •Severe and current psychotic disorder
- •Dementia/other neurodegenerative disease
- •History of previous stroke (/strokes) if not recovered, excluding TIAs (the criteria for the recovery: no residual aphasia or other disabilities caused by stroke which would affect in significant manner on everyday life)
- •Active epilepsy / migraine (< 3 years)
- •Severe apraxia of speech
- •Inability to act according to given instruction
- •Severe neuropsychological disorder or the decline of cognitive / memory functions, which would significantly affect for training during the VR-intervention
- •Vision or hearing impairment which would prevent the use of VR HMD
- •if the participant's treatment or medication is unsuitable with the use of VR HMD device as assessed by the physician
- •if the participant has the pacemaker or implantable (electric) medical device
结局指标
主要结局
Change in language abilities from baseline to week 9 and to week 18
时间窗: Change from baseline to week 9 and to week 18
Language abilities are assessed using language quotient LQ score of Western Aphasia Battery (WAB), performed at the baseline (prior the intervention periods) and after each intervention period (i.e. after the VR-intervention period and the waitlist period)
Change in quality of life from baseline to week 9 and to week 18
时间窗: Change from baseline to week 8 and to week 18
Quality of life is assessed with Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39), performed at the baseline (prior the intervention periods) and after each intervention period (i.e. after the VR-intervention period and the waitlist period)
Change in naming abilities from baseline to week 9 and to week 18
时间窗: Change from baseline to week 9 and to week 18
Naming abilities for nouns and verbs are assessed with Boston Naming Test (BNT) and TNT-test (action naming test in Finnish) performed at the baseline (prior the intervention periods) and after each intervention period (i.e. after the VR-intervention period and the waitlist period)
Change in verbal fluency from baseline to week 9 and to week 18
时间窗: Change from baseline to week 9 and to week 18
Verbal fluency is assessed using multiple categories (produced words per one minute in each category), performed at the baseline (prior the intervention periods) and after each intervention period (i.e. after the VR-intervention period and the waitlist period)
Change in functional communication skills from baseline to week 9 and to week 18
时间窗: Change from baseline to week 9 and to week 18
Functional communication skills are assessed with Communication Effectiveness Index (CETI), performed at the baseline (prior the intervention periods) and after each intervention period (i.e. after the VR-intervention period and the waitlist period)
次要结局
- Data collected by VR-devices regarding the performance of participants during the VR-intervention(Through the VR-intervention up to 8 weeks or through the weeks 10-17, depending of the group the patient has been randomized)
- Participants' experiences of the VR-intervention(After VR-intervention period, at the week 9 or at the week 18, depending of the group the patient has been randomized)
- Participants' experiences of the waitlist period(After waitlist period, at the week 9 or at the week 18, depending of the group the patient has been randomized)
- Attrition rates during the study.(Through study completion, up to 18 weeks)
- Date collected by remote sessions regarding the experiences of participants and feasibility of VR-intervention(Weekly during the VR-intervention up to 8 weeks or through the weeks 10-17, depending of the group the patient has been randomized)
研究者
Matti Lehtihalmes
Professor
University of Oulu