Evaluating Potential Changes in Symptoms Associated With Parkinson's After 6-12 Weeks of Wearing the Beechband
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Modified Unified Parkinson's Disease Rating Scale Motor Score (Modified UPDRS)
研究概览
简要总结
Parkinson's disease can affect movement, balance, and everyday activities. The Beechband is a wrist-worn device that provides intermittent vibrations. Some people have reported improvements in symptoms while wearing the device, but there is currently little scientific evidence to support these reports.
This pilot study will explore whether movement symptoms and participants' perceptions of their symptoms change after wearing the Beechband for 6 or 12 weeks. Approximately 60 people with Parkinson's disease will be randomly assigned to one of two groups. One group will wear the Beechband for 12 weeks. The other group will continue their usual activities without the Beechband for the first 6 weeks and will then wear it for the following 6 weeks. Participants will be asked to wear the device for approximately 6 hours each day during their assigned wearing period.
Assessments will be conducted remotely by video call at the beginning of the study and after 6 and 12 weeks. They will include measures of movement and balance, a timed walking task, and questionnaires about symptoms and everyday experiences. Device use and any unwanted or unexpected effects will also be recorded.
The study is intended to estimate the size of any possible changes and assess the feasibility of a future larger clinical trial. It is not designed to provide definitive evidence that the Beechband is effective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of idiopathic Parkinson's disease according to UK Parkinson's Disease Society Brain Bank criteria
- •Able to participate in online video calls
排除标准
- •Montreal Cognitive Assessment (MOCA) score below 16
- •Previous use of a Beechband, or another vibrating wrist-worn device, for managing symptoms associated with Parkinson's disease
- •Any neurological diagnosis other than Parkinson's disease that affects cognition or memory, pain, or movement
- •Significant memory problems that could interfere with the ability to provide informed consent
- •Unable to stand or walk without assistance for at least 1 minute
- •Any electronic implant, including deep brain stimulation or a pacemaker
研究组 & 干预措施
Immediate Start Beechband
Participants wear the Beechband for approximately 6 hours per day throughout the 12-week study period.
干预措施: Beechband (Device)
Delayed Start Beechband
Participants continue their usual activities without wearing the Beechband during the first 6 weeks. They then wear the Beechband for approximately 6 hours per day during Weeks 6-12.
干预措施: Beechband (Device)
结局指标
主要结局
Modified Unified Parkinson's Disease Rating Scale Motor Score (Modified UPDRS)
时间窗: Baseline, Week 6, and Week 12
Motor symptoms are assessed remotely using the Unified Parkinson's Disease Rating Scale. Items that cannot be assessed reliably by video, including rigidity and postural instability, are omitted. Retained items are scored and summed, with higher scores indicating more severe motor symptoms. Assessments following a Beechband-wearing period also include measurements with the device switched on and switched off.
次要结局
- Timed Up and Go Test Completion Time(Baseline, Week 6, and Week 12)
- Falls Efficacy Scale - International (FES-I)(Baseline, Week 6, and Week 12)
- Visual Sensitivity Scale (VSS)(Baseline, Week 6, and Week 12)
- Gait Specific Attentional Profile (G-SAP)(Baseline, Week 6, and Week 12)
- Generalised Anxiety Scale (GAD-7)(Baseline, Week 6, and Week 12)