Evaluation of the Acceptability and Usability of the MAGIC-GLASS Solution as Part of the Care Pathway in People With Acute, Sub-Acute and Chronic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 7
- 主要终点
- the usability of the intervention;
研究概览
简要总结
Background: Virtual Reality (VR) technology may help to provide a way for stroke survivors to exercise in their own time at home, with remote clinical support. Before investigators introduce this technology there is a need to test that it will work alongside current health services for stroke survivors. Aims: To find out if using the MAGIC-GLASS solution alongside current healthcare care is usable and acceptable to stroke survivors and helps to increase rehabilitation time. Design: Measures before and after stroke survivors use the MAGIC-GLASS solution.
Setting: Stroke survivors will use the MAGIC-GLASS solution in their own home. Population: adults (≥18 years) who have had a stroke at least two weeks before they enter into the study.
Interventions: Our VR technology is called MAGIC-GLASS, and in order to use the solution the user puts on a headset which is connected to a computer. Participants can then see a VR environment in which they will be able to see virtual hands that respond to the movements of their own hands. It will also be possible to see a mirror image of their hands moving. The system will record how much they use the system and improvement in their movement. Regular contact will be made with a clinician who will be able to use the system to see (from their clinic) how the stroke survivor is doing and talk to them. Outcomes: The investigators want to find out how the stroke survivors' movement changes over time and what they think of using the system. Investigators will also ask clinical staff what they thought of using the system as part of healthcare provision to stroke survivors. Finally investigators want to find out how much it will cost to use the system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any time point post stroke
- •Medically stable (and without uncontrolled seizures or vertigo)
- •No or mild cognitive deficit: can follow two step commands
- •No significant visual or spatial neglect (Can turn head towards an image when asked to do so and keep attention). People with hemianopia or other visual deficits can be included dependent on clinical opinion
- •Normal or normal corrected vision
- •Be able to get in and out from a seat with assistance; can be used in a wheelchair as long as arms can rest on table
- •Have a carer to assist putting on the headset
- •Be willing to give consent
- •For those not using mirror therapy, can move impaired arm without significant pain
排除标准
- •• People with a moderate to severe cognitive impairment (MoCA<20).
- •Those with a visual impairment who are unable to see a clear image with the headset.
- •Patients with severe neuropsychological deficits such as severe neglect or apraxia as indicated by their clinical team.
- •Patients who are medically unwell e.g. with history of solid organ or bone marrow transplantation, active malignancy within 24 months prior to screening or metastatic cancer, life expectancy less than 6 months, Congestive heart failure in New York Heart Association (NYHA) Functional Classification IV (severe) stage.
- •Those with complete dependency in Activities of Daily Living, any medical or other reason (e.g. known or suspected inability of the participant to comply with the protocol procedure) that investigator opinion that the participant is unsuitable for the study.
- •Patients unwilling to provide consent and those who cannot be followed-up at any time point will be excluded from the study.
- •Epilepsy, seizures and history of vertigo (possible exclusion determined by clinician).
- •Those with upper limb sensory disturbance who are unwilling to keep their nails short for the duration of the study.
研究组 & 干预措施
VR intervention
Each participant received an individualised UL training programme focusing on gross and fine motor movements via the MAGIC -GLASS system, using a VR headset followed by fortnightly remote clinical contacts up to month six.
干预措施: Magic Glass (Device)
结局指标
主要结局
the usability of the intervention;
时间窗: through study completion, an average of 6 months
Combination of interviews with users, carer questionnaire, focus groups with clinicians will be used to assess usability using qualitative analysis
the usability of the intervention
时间窗: through study completion, an average of 6 months
System usability score questionnaire
the process requirements for the new care pathway;
时间窗: through study completion, an average of 6 months
Combination of interviews with users, carer questionnaire, focus groups with clinicians and will be analysed qualitatively
the resource requirements for the new care pathway;
时间窗: through study completion, an average of 6 months
Combination of interviews with users, carer questionnaire, focus groups with clinician and will be analysed qualitatively
the acceptability of the intervention
时间窗: through study completion, an average of 6 months
Combination of interviews with users, carer questionnaire, focus groups with clinicians will be used to assess acceptability by analysing qualitatively
the intensity in Rehabilitation Therapy
时间窗: Change from baseline to end of intervention (6 months)
measured in clinical dashboard
the duration in Rehabilitation Therapy
时间窗: Change from baseline to end of intervention (6 months)
measured in clinical dashboard
次要结局
- Functional independence in the activities of daily living with respect to the modified Rankin Scale(Change from baseline to end of intervention (6 months))
- cognitive function(Change from baseline to end of intervention (6 months))
- Stroke specific quality of life(Change from baseline to end of intervention (6 months))
- physical activity as measured by range of motion(Change from baseline to end of intervention (6 months))
- potential cost effectiveness of the solution(Change from baseline to end of intervention (6 months))
- Functional independence in the activities of daily living with respect to the Barthel Index(Change from baseline to end of intervention (6 months))
- Functional independence in the activities of daily living with respect to the Modified Rankin Scale(Change from baseline to end of intervention (6 months))
- physical activity as measured by Range of Motion(Change from baseline to end of intervention (6 months))
- Cognitive function measured by the Montreal Cognitive Assessment(Change from baseline to end of intervention (6 months))
- Stroke specific quality of life questionnaire(Change from baseline to end of intervention (6 months))