Useability and Acceptability of the CUE1 Device in Older People With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Useability and acceptability of the CUE1 device in older people with Parkinson's disease
研究概览
简要总结
The CUE1 device is a non-invasive wearable device for people with Parkinson's Disease (PD) approved for sale in the UK. The CUE1 device utilises two established methods to improve motor symptoms in PD, namely pulsed cueing and vibrotactile stimulation. Many people with PD wish to explore non-pharmacological interventions as an adjunct to manage their motor symptom.
Study design and eligibility: This feasibility study is to establish whether the CUE1 device is a useable and acceptable device for older people with PD. 20-25 participants aged >60 years with PD will be recruited from a movement disorder service to the study.
Methodology: Participants will undertake baseline assessments of motor symptoms and quality of life with a PD nurse assessor in their own home. Following this the CUE1 device will be fitted and repeat assessments of motor symptoms will take place after 20 minutes. The participants will complete a daily diary of useability and acceptability for 4 weeks. A second visit will occur at 4 weeks with the same PD nurse assessor where the final set of motor symptom and quality of life assessments will be completed.
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
- 60 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals under the care of a Cambridge University Hospitals Foundation Trust movement disorder service with an established clinical diagnosis of Parkinson's disease based on the UK Brain bank criteria
排除标准
- •Co-existing significant neurological disorder (disabling stroke, multiple sclerosis, dementia, motor neurone disease),
- •Atypical parkinsonian disorder diagnosis (e.g. multiple systems atrophy, progressive supranuclear palsy or cortical basal degeneration syndrome)
- •co-existing physical impairment or disability causing significant mobility impairment (severe lower limb osteoarthritis)
- •trauma or pain to the sternum
- •use of other medical device e.g. pacemaker, deep brain stimulator, TENS machine etc
- •lacking capacity to consent to the study
- •Sensitivity to medical adhesives
- •Existing participant in intervention research trial
结局指标
主要结局
Useability and acceptability of the CUE1 device in older people with Parkinson's disease
时间窗: 4 weeks
Participants' completion of a patient diary which will collect safety, tolerability, useability, and efficacy reports of the device over the study period. Participants will also complete a Patient Global Impression of Change (PGI-C) questionnaire at the end of the study.
次要结局
- To undertake standardized, validated measurements of motor function with use of the CUE1 device(4 weeks)
研究者
Dr Alistair Mackett
Consultant Geriatrician
Cambridge University Hospitals NHS Foundation Trust