Immersive Virtual Reality for Dysphagia Treatment After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Feasibility of the system. Semi-structure Interviews with patients and staffs. Qualitative outcomes.
研究概览
简要总结
People who have suffered a stroke are at high risk of suffering from oropharyngeal dysphagia with long and intensive exercise programmes. Early access to treatment and engaging therapies is very important for recovery. Immersive virtual reality technology presents an innovative treatment that could help patients improve swallowing. The aim of this study is to improve swallowing in stroke patients using two bespoke immersive virtual reality treatment with real-time feedback. The study consisted in a small feasibility study with stroke patients suffering dysphagia (n = 6, aged of 39 to 80 (M=71.17, SD=15.94). Results obtained through interviews with the patients indicated no discomfort reported during the game. All patients reported enjoying the game and feeling engaged and immersive and four out of six patients reported that they would like to use it every day as part of their Speech and Language therapy. The SALT assistant involved in the study stated that the system had the potential to encourage patients to swallow, being more functional than conventional speech therapy. She identified improvements needed for a better functioning of the VR rehabilitation system for Dysphagia. In a future study, wireless headsets will be used, without a laptop, and it will be important to improve the reliability and design of the strain gauge or innovate in the use of a different technology.
详细描述
- Design of the research.
A priority of the team was to ensure the VR system and game experience is suitable for rehabilitation purposes and use in a clinical setting with OD patients. The research study has been designed collaboratively, with consultations between the research team and relevant clinical staff playing a key role in the development of the IVR intervention. This preliminary work has been further enhanced through:
- Observation of clinics to establish movements required during rehabilitation.
- A PPI / expert workshop at early development stage.
- Play test with healthy volunteers (n = 10) to check usability, acceptability of VR and effectiveness of strain gauge measurement process.
- Ongoing development informed by consultation with relevant parties and above stages.
- PPI and contributions. A workshop was conducted which involved people with personal experience of or professional expertise in dysphagia and swallowing problems, which was very valuable in informing and refining the IVR intervention study.
For this study, further IVR testing sessions were conducted utilising the updated version of the game with healthy adult volunteers. Insights gained from this final stage regarding the enjoyability, usability appropriateness and experience of the scenarios will inform any final amendments to the intervention. 3. Eligibility inclusions and exclusions. The target sample for the clinical feasibility trial was 10 adult (aged 18+) stroke in-patients receiving care at the Stroke.
Pathway Assessment and Rehabilitation Centre (SPARC) in at STH during the recruitment period of the study.
In addition to the above, inclusion criteria were comprehension and communication skills sufficient to understand instructions, give informed consent and communicate experiences. Interpreters was provided for people whose first language is not English. People with a mild language or cognitive impairment (common after stroke, which can affect comprehension and communication) was included and supported to participate by the local SALT. People with mild-moderate well-controlled mental health problems could be included, as well as those with a history of mildmoderate motion sickness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •The target sample for the clinical feasibility trial is 10 adult (aged 18+) stroke in-patients receiving care at the Stroke.
- •Pathway Assessment and Rehabilitation Centre (SPARC) in at STH during the recruitment period of the study.
- •In addition to the above, inclusion criteria are comprehension and communication skills sufficient to understand instructions, give informed consent and communicate experiences. Interpreters would be provided for people whose first language is not English. People with a mild language or cognitive impairment (common after stroke, which can affect comprehension and communication) will be included and supported to participate by the local SALT. People with mild-moderate well-controlled mental health problems could be included, as well as those with a history of mildmoderate motion sickness.
排除标准
- •A severe language, communication or cognitive impairment preventing full consent or engagement.
- •Hemianopia preventing stereoscopic vision.
- •Severe mental health issues which could give rise to unnecessary. psychological or physical distress during IVR use.
- •Head or neck injuries which would prevent participants wearing the IVR headset and strain gauge around the neck.
- •A history of severe motion sickness since, since IVR can occasionally stimulate motion sickness in those already strongly affected by these symptoms.
- •A qualified speech therapist in the SPARC SALT team would identify the eligibility of inpatients for the study, based on the above inclusion and exclusion criteria.
- •The two members of staff involved in delivering the intervention will also take part in interviews following completion of the study.
研究组 & 干预措施
Dysphagia patients using VR
Day 1: Consent taken 5mins. Baseline period wearing strain gauge 5mins, it´d pick up and measure the patient's swallow movements while at rest not using the VR. IVR trial 25mins, the headset will be refitted and instructions to use two different games for up to 10 minutes with a 5-minute break in between. The SALT Assistant would be closely guide and monitor the participant. The experience will be concluded for the day if the participant shows sign of or indicates discomfort.
Days 2-4 (30-35mins) same proceed as above, minus the test experience (Baseline period (5 mins) and IVR trial (25 mins).
Day 5 (40-45mins) final day of the trial and after take part in a short semi-structured interview (10mins) in person and audio recorded by the SALT Assistant. SALT Assistant post-trial interview (25-40mins) online audio recorded by a member of the research team .
干预措施: Immersive Virtual Reality for Dysphagia Treatment (Device)
结局指标
主要结局
Feasibility of the system. Semi-structure Interviews with patients and staffs. Qualitative outcomes.
时间窗: 10 to 40 minutes interviews
After the trial to obtain feedback from the patients and speech therapist assistant in the clinical trial, semi structured interviews were use. Questions were focus on their experience of the headset, strain gauge and IVR intervention, and their experiences and perceptions of swallowing whilst playing. Staff questions were focus on her experience of using the IVR with the patient, their perceptions of its effectiveness, usability, potential and limitations. Qualitative data was gathered from patient and staff interviews. A qualitative content analysis was conducted to identify the key experiential and perceptual findings.
Feasibility of the system. Semi-structure Interviews with patients. Quantitative outcomes.
时间窗: 10 to 40 minutes interviews
The interview will have ten question of liker scales eleven (0-10) answer rate (eg. How comfortable was it to wear the VR headset?; 2. How comfortable was it to wear the strain gauge?). Descriptive statistical analyses were conducted using SPSS statistical package.
次要结局
未报告次要终点