The Feasibility of Implementing Virtual Reality-based Upper Limb Rehabilitation for Stroke Patients and Occupational Therapists in an Acute Stroke Unit and Community Stroke Team, in Terms of Technology Acceptance, Safety and Usability
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- System Usability Scale
研究概览
简要总结
The study aims to assess the feasibility of using Resynk, a virtual reality (VR) software platform for upper limb rehabilitation for stroke survivors, both in acute hospital settings and in the community (home, private nursing home, residential home). Resynk offers interactive, task-oriented training that enhances therapy intensity and patient motivation. Previous findings from a Quality Improvement project showed significant increases in treatment intensity and patient engagement with Resynk. This study will explore barriers to Resynk implementation and gather input from staff participants and stroke survivors to ensure successful integration and effectiveness.
Resynk will be delivered alongside standard care, with no intention to delay or reduce existing rehabilitation services. The study involves two participant groups -adult stroke survivors and Occupational Therapists. These represent realistic and appropriate user groups for this stage of implementation research. A control group is not included, as the primary aim is not comparative effectiveness but to assess feasibility and user experience.
This study will use a exploratory approach to using qualitative methods for gather insight into safety, acceptability and usability such as the System usability Scale, EQ-5D-5L and custom design Questionnaire. Quantitative methods will be used for evaluating rehabilitating and function outcomes this includes data collected by the Resynk application and the standardised Fugl Meyers assessment. The study will involve pre, post and follow up data collection for both participant groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stroke Participants
- •Able to provide informed consent
- •Aged over 18 years.
- •Evidence of stroke confirmed by medical team
- •Newly diagnosed patients who are admitted to the acute stroke unit with a confirmed diagnosis of stroke.
- •More than 48 hours since stroke event
- •Patient is appropriate to participate in rehabilitation according to the treating physician or medical consultant, and able to follow simple verbal commands.
- •Presence of an upper limb deficit identified in the NIHSS (National Institutes of Health Stroke Scale) or by a member of the medical or multidisciplinary team
- •Residents within the Belfast health and social care trust catchment area/postcode
- •Staff participants:
- •Qualified Registered Occupational Therapy Staff who work in the Stroke Unit in the Royal Victoria Hospital Belfast or in the Community Stroke Team in the Belfast Health and Social Care Trust.
- •Able to provide informed consent
- •Aged 18 or over
排除标准
- •Stroke Participants:
- •Stroke onset more than 3 months prior to study entry.
- •Acutely medically unwell as per medical team
- •Patient is unable to follow verbal commands or has global aphasia. Interpreters may be used to accommodate stroke survivors' communication needs.
- •Severe illness with a life expectancy of less than 3 months (e.g., cancer, endocarditis, metastasis with an occult primary malignancy).
- •Uncontrolled hypertension as assessed by the treating physician.
- •Unstable angina or recent myocardial infarction.
- •Any history of epilepsy or seizures, except for febrile seizures of childhood.
- •Current participation in another clinical trial involving rehabilitation (e.g., recreational therapy, occupational therapy, physiotherapy) or an investigational drug that might interfere with study results.
- •Patient is unwilling or unable to comply with the protocol or cannot/will not cooperate fully with the investigator or study personnel.
- •Any physical health condition, mental health condition, or other medical condition or diagnosis that might confound the interpretation of results or put the patient at risk (e.g., amputation of one extremity).
- •History of vertigo.
- •Active delirium/significant levels of confusion
- •Cervical artery dissection.
- •Patients with implanted devices such as pacemakers, defibrillators, and cochlear implants.
- •Individual currently being managed under the Mental Capacity Act
- •Staff participants:
- •Uncontrolled hypertension as assessed by the treating physician.
- •Unstable angina or recent myocardial infarction
- •Any history of epilepsy, seizures, except for febrile seizures of childhood.
- •Current participation in another clinical trial involving rehabilitation (e.g., recreational therapy, occupational therapy, physiotherapy) or an investigational drug that might interfere with study results.
- •Any physical health condition, mental health condition, or other medical condition or diagnosis that might confound the interpretation of results or put the patient at risk (e.g., amputation of one extremity).
- •History of vertigo.
- •Cervical artery dissection.
- •Staff members with implanted devices such as pacemakers, defibrillators, and cochlear implants.
研究组 & 干预措施
stroke survivor participant group
Participants receive VR therapy 30mins of the intervention 3 times a week for 4 weeks
干预措施: Resynk VR session (Device)
Occupational therapist Participant group
Occupational therapist Participants receive training and use VR on stroke survivor participants
干预措施: Using Resynk VR on stroke survivors (Other)
结局指标
主要结局
System Usability Scale
时间窗: Day 1 & Day 30
Scale assess the usability of the resynk VR system for both arms higher score mean higher usability
Safety and Acceptability Questionnaire
时间窗: Day 1 & Day 30
A custom Questionnaire to evaluate the safety and acceptability of Resynk VR in both arms
次要结局
- Upper limb function (Fugl-Meyer Assessment)(Day 1 & Day 30)
- Quality of life (EQ-5D-5L)(Day 1 & Day 30 & Day 60)
- self-efficacy (General Self-Efficacy Scale)(Day 1 & Day 30)
- rehabilitation intensity (resynk repetition count vs average conventional therapy based on literature)(Day 1 & Day 30)