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临床试验/NCT03493633
NCT03493633终止不适用

Study of Use of the EzyGain Training and Rehabilitation Device for Walking at Home

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2018年7月31日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
15
试验地点
1
主要终点
Number of sessions performed on the device during the duration of the study

研究概览

简要总结

Our research hypothesis is that the practice of walking on a secure treadmill is possible at home and allows the patient to increase the training work of walking in everyday life compared to a conventional care.

详细描述

Our research hypothesis is that the practice of walking on a secure treadmill is possible at home and allows the patient to increase the work of training of walking in everyday life compared to a conventional care. In addition, we believe that this practice should be supervised by a caregiver trained by the physiotherapist / APA investigator, in order to increase the use of the device.

The people concerned by this protocol are those who have a partial disability of walking whatever the pathology and the underlying deficiencies.

Main objective: To evaluate the feasibility of using EzyGain at home.

Main Evaluation Criteria: Number of sessions performed on the device during the duration of the study, compared to the number of scheduled sessions.

Secondary objectives

研究设计

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

入排标准

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

入选标准

  • Person over the age of 60
  • Availability at home during their participation period (walking exercise weeks + physical activity assessment weeks).
  • Patient with a volunteer close caregiver to participate in the study and receive training from the investigator/APA investigator and then manage autonomy sessions.
  • Person who would like to train more regularly in the walk and at home because unable to get out. Person who uses or does not use technical assistance to walk or move
  • Person in a State to sign informed consent alone
  • Possibility of installation of the device in the patient's home (the dimensions of the lift/doors/parts allow the device to be entered in the apartment, as well as not to hinder the daily life of the patient too heavily).
  • Patient affiliated with a Social security plan
  • Person who has a partial limitation of walking activity (partial inability to walk) and in whom, re-education of walking is relevant to improve performance (whether or not the patient does this re-education at the time of the visit of selection). The criteria for limiting walking activity are:
  • Speed limitation
  • Endurance limitation
  • Limitation of the operating perimeter
  • Limitation of the dynamic balancing during walking failure to position the foot or feet during walking
  • Availability at home during their time of participation.
  • Indifferent ethnic origin
  • Indifferent sex

排除标准

  • Uncontrolled heart failure
  • Uncontrolled respiratory insufficiency
  • Uncontrolled coronary insufficiency
  • Impossibility of installing the device at home
  • Severe cognitive impairment with risk of using the device alone, outside of the instructions
  • Absence of a caregiver to follow a continuous training of the physiotherapist / - APA investigator to supervise independently one or two sessions per week

结局指标

主要结局

Number of sessions performed on the device during the duration of the study

时间窗: Up to 4 weeks

Count of the number of sessions performed. A session is considered to be performed when the patient is walking for at least one minute on the EzyGain treadmill with the APA investigator / caregiver.

次要结局

  • Number of sessions performed autonomously by the caregiver(Up to 4 weeks)
  • Physical activity evaluate by actimetry before the training period(At days 7 before the training period)
  • Physical activity evaluate by QAPPA before the training period(At days 7 before the training period)
  • Physical activity evaluate by actimetry just after the training period(At days 7 after the end of the training period)
  • Physical activity evaluate by QAPPA just after the training period(At days 7 after the end of the training period)
  • Physical activity evaluate by actimetry 3 weeks after the training period(At 3 weeks after the training period)
  • Physical activity evaluate by QAPPA 3 weeks after the training period(At 3 weeks after the training period)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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