跳至主要内容
临床试验/NCT03790644
NCT03790644已完成不适用

Assistive Device to Improve Physical Performance in Patients With Very Severe Chronic Respiratory Disease - Evaluated Using a Single-Case Series Experimental Design

West Park Healthcare Centre2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2018年8月1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
6
试验地点
2
主要终点
walking endurance time

研究概览

简要总结

Chronic respiratory disease (CRD) is among the most prevalent and growing diseases worldwide with disabling consequences. Many with a compromised respiratory system cannot support the metabolic energy demands of walking causing them to walk slowly and stop often. Those with CRD could receive substantial benefit from a powered wearable exoskeleton device that assumes part of the energy of walking. Assisting the legs will lower the metabolic energy demands, and therefore the ventilation required for exercise, thereby allowing them to walk faster and further. Proposed is a series of single-case experiments comparing walking endurance with and without a powered exoskeleton assist. The aim of this study is to determine the efficacy of an exoskeleton on walking endurance in ventilatory limited patients with CRD. An exoskeleton could be a novel immediate and long term strategy to augment walking as part of the spectrum of pulmonary rehabilitation and community reintegration.

研究设计

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

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

  • stable chronic respiratory disease
  • modified medical research council dyspnoea score (mMRC) ≥ 2

排除标准

  • evidence of cardiac rhythm or circulatory compromise
  • myocardial infarct within the previous three months
  • moderate-severe aortic stenosis
  • uncontrolled hypertension
  • sustained cardiac arrhythmias
  • untreated neoplasia
  • lung surgery within the previous three months
  • any other predominant co-morbidities or treatments that might influence walk testing
  • body size outside of exoskeleton fit specifications
  • skin sores or skin breakdown in the area where the device is worn
  • a high risk of fracture

结局指标

主要结局

walking endurance time

时间窗: an average of 7 tests over 4 weeks

tolerance (time) of an individualized constant, brisk, walking speed endurance test

次要结局

未报告次要终点

研究者

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

Roger Goldstein

Director, Program in Respiratory Rehabilitation

West Park Healthcare Centre

研究点 (2)

Loading locations...

相似试验