跳至主要内容
临床试验/NCT05830253
NCT05830253已完成不适用

Free-living Monitoring of Parkinson's Disease Using Smart Objects: Towards Digital Medicine

Istituti Clinici Scientifici Maugeri SpA1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年9月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
System Usability Scale

研究概览

简要总结

Parkinson's disease, one of the most common neurodegenerative diseases of the central nervous system, presents motor symptoms, including tremor, rigidity, bradykinesia, and postural instability. Assessments of patients with Parkinson's disease are typically performed using clinical scales, compiled by the healthcare staff or by the patient. Although commonly used in clinical practice, they have some limitations, including the low temporal resolution of the scales, the low granularity of the scores and the possible low inter- and intra-operator reliability. The recent development of digital technologies has led to the creation of IoT (Internet of Things) devices capable of providing quantitative indicators, potentially useful for an accurate differential diagnosis, as well as for monitoring the effects of therapeutic interventions. The peculiarity of these systems is the ability to provide indicators not only during periodic visits to the clinic, but also the ability to remotely monitor the patient's daily life activities. In this scenario, this study wants to test the hypothesis that the IoT devices like smart-ink pens and insoles are usable options for monitoring patients with Parkinson's disease.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult individuls
  • Cognitive impairments
  • Ability to independently sign the written informed consent

排除标准

  • Unstable pharmacological treatment for Parkinson's Disease during the study
  • Previous history of major neurological, vascular, musculoskeletal disorders

结局指标

主要结局

System Usability Scale

时间窗: 1-2 weeks

Score ranges from 0 (no usability) to 100 (excellent usability)

次要结局

  • Movement Disordered Society - Unified Parkinson's Disease Rating Scale(Baseline)
  • Execution handwriting time(1-2 weeks)
  • Gait speed(1-2 weeks)
  • Average handwriting force(1-2 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验