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临床试验/NCT04285970
NCT04285970Unknown不适用

Analysis of the Motion Activity Manual Wheelchair Users

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2019年11月4日最近更新:
适应症

试验速览

阶段
不适用
入组人数
55
试验地点
1
主要终点
Confirm the identification of propulsion cycles during a journey at constant speed (5km/h)

研究概览

简要总结

Currently, there is no system in place to allow manual wheelchair users to know their quantities of movement activities and the intensity of effort to be provided during these propulsion movements. Based on recent work by Routhier et al. in 2017, and in light of the scientific literature related to wheelchair propulsion, it would seem appropriate to validate the use of inertial units as tools to quantify and categorize the intensity of manual wheelchair propulsion.

详细描述

The investigator hypothesize that an inertial unit positioned on the wheelchair wheel has the same detection rate of the propulsion cycle as a dynamometric wheel (step 1). In addition, the investigator hypothesize that the categorization of the detected propulsion cycle as a function of force intensity is similar between the angular deceleration of the wheel during propulsion calculated from the inertial unit and the external mechanical power calculated from a dynamometric wheel (step 2).

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • For the healthy user group volunteers:
  • Men or women over 18 years of age,
  • An experience of at least 2 hours using the manual wheelchair,
  • Subject who has signed an informed and written consent,
  • Affiliation to a social security system.
  • For the spinal cord injured user group:
  • Men or women over 18 years of age,
  • Injured Medullary users of manually propelled wheelchairs for daily locomotion (at least 30/100 at WST on travel items),
  • Subject who has signed an informed and written consent,
  • Affiliation to a social security system.

排除标准

  • Patient refusing to participate in the study,
  • Manual wheelchair users with propulsion assistance system,
  • Major cognitive disorders,
  • Unbalanced cardiovascular disease,
  • Pressure sores and unhealed palm lesions,
  • Asthma to effort,
  • Progressive etiologies: tumor, infectious, inflammatory and associated - - pathologies: head trauma, amputation,
  • Patient under guardianship or curatorship,
  • Pregnant or breastfeeding woman.

结局指标

主要结局

Confirm the identification of propulsion cycles during a journey at constant speed (5km/h)

时间窗: 18 months

Measurement of the detection rate of propulsion cycles

Confirm the classification of propulsion cycles by effort intensity

时间窗: 18 months

Classification rate of propulsion cycles

次要结局

  • Study of the association between the propulsion force and the coefficient of the deceleration slope(18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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