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临床试验/NCT05982730
NCT05982730招募中不适用

SegwayPD: The Effect of Sensory-augmented Postural Training Using Segway on Motor and Cognitive Function in Individuals With Parkinson's Disease

University of Texas Southwestern Medical Center2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年11月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
15
试验地点
2
主要终点
Change from baseline postural sway at week 3

研究概览

简要总结

The purpose of this study is to examine the safety and efficacy of postural training emphasized on the integration of multiple sensory information into motor control in individuals with PD. This project is a proof-of-concept study to assess the effectiveness of postural training using Segway, which serves a platform to provide augmented and continuous proprioceptive and visuospatial information during postural training.

详细描述

The purpose of this study is to examine the safety and efficacy of postural training emphasized on the integration of multiple sensory information into motor control in individuals with PD (Parkinson's disease). This project is a proof-of-concept study to assess the effectiveness of postural training using Segway, which serves a platform to provide augmented and continuous proprioceptive and visuospatial information during postural training. Specifically, we will measure postural sway during quiet standing, single and dual-task walking performances, and brain activation during single and dual-task walking from the regions involved in planning and execution of locomotion; these include dorsolateral prefrontal cortex, premotor cortex and primary motor cortex. The changes in visuospatial function and proprioception after training will also be assessed. Individuals with moderate disease stage of PD exhibiting postural instability will be recruited. The participants will receive 1-week training and be assessed at 3 time points: 1-week before, before, and after the training.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • a clinical diagnosis of idiopathic PD with moderate disease stage presenting balance alterations (Hoehn and Yahr stage III)
  • being stable on medication for at least 1 month
  • the ability to stand and walk unsupported for 5 min both on and off medication
  • age between 50 and 85

排除标准

  • neurological disorders other than PD
  • major unstable medical illnesses
  • sensory or musculoskeletal disorders (e.g., diabetes, uncorrected visual problems, arthritis, severe hearing impairments) that will prohibit the ability to perform the assessment tests and receive training

结局指标

主要结局

Change from baseline postural sway at week 3

时间窗: Week 1 (2 assessments), Week 3 (1assessment)

The midpoint between the tip of left and right calcaneus bones is considered as the origin of the reference system of the center of pressure (CoP). The CoP displacement along lateral and anterior-posterior axes are measured. The overall size of postural sways will be estimated from the ellipse area conveying 85% of the total CoP samples. The postural sway obtained from 2 assessments during week 1 will be averaged and used as baseline value. The postural sway obtained at week 3 is used to analyze the change from baseline due to training intervention (week 2).

次要结局

  • Feasibility of Segway training(Week 3 (1 assessment))
  • Change from baseline gait spatiotemporal parameters at week 3(Week 1 (2 assessments), Week 3 (1assessment))
  • Change from baseline EEG spectral ratio at week 3(Week 1 (2 assessments), Week 3 (1assessment))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yasin Dhaher

Professor of Medicine

University of Texas Southwestern Medical Center

研究点 (2)

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