ACTRN12621001369819招募中未知
A clinical feasibility study to evaluate the Bionics Institute Rigidity Device (BiRD) at quantifying motor symptoms in people with Parkinson’s disease.
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Diagnosis
入排标准
- 年龄范围
- 18 Years 至 o limit(—)
- 性别
- All
入选标准
- •All participants with Parkinson's disease:
- •* Have a diagnosis of Parkinson's disease by a neurologists as per the UK Parkinson's Disease Brain Bank Diagnostic Criteria
- •* Are capable of providing informed consent
- •* Are capable of attending the research site for data collection.
- •Participants with Parkinson's disease who are primarily treated with deep brain stimulation:
- •* Have deep brain stimulation electrodes implanted bilaterally into the subthalamic nucleus region
- •* Experience stable management, defined as no changes to medication or DBS program for a period of two months prior to data collection.
- •Healthy volunteers:
- •* Are in good general health
- •* Are capable of providing informed consent
- •* Are capable of attending the research site.
排除标准
- •All participants with Parkinson's disease:
- •* Have a significantly limited range of movement at the metacarpal joints
- •* Have a known or suspected diagnosis of bone disease that affects the upper limb
- •* Have a known or suspected diagnosis of joint disorder that affects the upper limb
- •* Have a disease or disorder affecting the neuromuscular system
- •* Previous surgical intervention to hand or finger, including amputation
- •* Previous history of brain surgery other than DBS implantation
- •* Comorbidities affecting rigidity, tremor, bradykinesia.
- •Participants with Parkinson's disease predominantly treated with DBS:
- •* Implanted with DBS less than three months prior to data collection.
- •Healthy volunteers:
- •* Have a limited range of movement at the metacarpal joints
- •* Have a known or suspected diagnosis of bone disease that affects the upper limb
- •* Have a known or suspected diagnosis of joint disorder that affects the upper limb
- •* Have a disease or disorder affecting the neuromuscular system
- •* Previous surgical intervention to hand or finger, including amputation
- •* Previous history of brain surgery
- •* Current prescription of medication known to cause changes in muscle tone, tremor, balance or other movement problems.
研究者
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