跳至主要内容
临床试验/NCT05349539
NCT05349539招募中不适用

Instrumental Assessment of Motor Symptoms by Means of Wearable Sensors in Patients With Parkinson's Disease

Neuromed IRCCS1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年6月1日最近更新:
适应症

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

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

发起方
Neuromed IRCCS
申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonio Suppa

Principal Investigator

Neuromed IRCCS

研究点 (1)

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