Instrumental Assessment of Motor Symptoms by Means of Wearable Sensors in Patients 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
- 50
- 试验地点
- 1
- 主要终点
- Time of OFF state of therapy during daily activity hours;
研究概览
简要总结
The clinical management of Parkinson's disease (PD) is frequently challenged by the occurrence of motor disorders and complications, such as freezing of gait, fluctuations and the ON-OFF phenomenon, primarily manifesting at home. Therapeutic decisions are usually based on periodic neurological examinations and patients' anamnestic experience collected in an outpatient setting, thus limited by several issues, including "recall bias" and subjective, semi-quantitative and operator-dependent evaluations in non-ecological settings. In the last two decades, new wearable technologies, consisting of "wireless" sensors (e.g., inertial, electromyography), have been widely applied to quantitatively assess movements in physiological and pathological conditions, even for prolonged periods in free-living settings (i.e., long-term monitoring). The aim of this study is to evaluate motor symptoms in patients with PD, such as bradykinesia, tremor, gait disturbances and balance disorders, objectively and quantitatively through the application of wearable sensors in intra- and extra hospital settings, also during common activities of daily living, in order to obtain ecological data possibly useful in the therapeutic management of the disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diagnosis of idiopathic Parkinson's disease according to current consensus criteria and confirmed by follow-up clinical evaluations;
- •ability to walk independently
排除标准
- •dementia (MMSE < 24/30);
- •comorbidities affecting gait (e.g., rheumatological or orthopedic issues);
- •atypical parkinsonism.
结局指标
主要结局
Time of OFF state of therapy during daily activity hours;
时间窗: 24 hours
Time spent with poor motor control despite optimized pharmacological therapy
Number of "Wearing Off" and "ON-OFF" phenomena
时间窗: 24 hours
Number of motor complications despite optimized pharmacological therapy
Number of "freezing of gait" episodes
时间窗: 24 hours
Number of paroxysmal gait disorders despite optimized pharmacological therapy
次要结局
未报告次要终点
研究者
Antonio Suppa
Principal Investigator
Neuromed IRCCS
