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临床试验/NCT03651960
NCT03651960已完成不适用

Mobile and Interactive Robot's Social Acceptability for Balance and Gait

Rennes University Hospital2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2015年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
42
试验地点
2
主要终点
Social acceptability of robot prototype for patient

研究概览

简要总结

The recovery of a balance and gait is a primary objective for geriatric, neurological or orthopedic rehabilitation. Since the 80s, many walking robots were proposed.

Despite encouraging results, the use of robotic equipment for gait training remains limited, even if they meet a strong social demand. The reasons for this situation are economic, but also related to the non consideration of the context of utilization . It is therefore important to involve the users of the innovation in the development process because it is the latter that will broadcast. Psychosocial perspective of the acceptability of the technology meets this need by including the users' perceptions toward device (s).

The ROBO-K project aimed at developping a mobile and interactive robot, dedicated to the rehabilitation of balance and gait at an early stage. It was intended for patients with impaired walking vascular neurological, traumatic or associated with chronic neurological disease. The first step for its developement was conducted with the psychosocial approach of Technology acceptability which has required specific methods for collecting the views of users and analysis of the activity. This process allowed the design and the development of robot prototypes.

The aim of the present study is now to establish the degree of social acceptability of the robot and to analyze balance and gait training activity.

详细描述

The recovery of a balance and gait is a primary objective for geriatric, neurological or orthopedic rehabilitation. Since the 80s, many walking robots were proposed.

Despite encouraging results, the use of robotic equipment for gait training remains limited, even if they meet a strong social demand. The reasons for this situation are economic, but also related to the non consideration of the context of utilization (eg therapeutic practices , users' expectations). It is therefore important to involve the users of the innovation in the development process because it is the latter that will broadcast. Psychosocial perspective of the acceptability of the technology meets this need by including the users' perceptions toward device (s).

The ROBO-K project aimed at developping a mobile and interactive robot, dedicated to the rehabilitation of balance and gait at an early stage. It was intended for patients with impaired walking vascular neurological, traumatic or associated with chronic neurological disease. The first step for its developement was conducted with the psychosocial approach of Technology acceptability which has required specific methods for collecting the views of users and analysis of the activity. This process allowed the design and the development of robot prototypes. The aim of the present study is now to establish the degree of social acceptability of the robot and to analyze balance and gait training activity. The data collected will validate the development of assumptions with users (e.g. static or dynamic balance exercises, rehabilitation of gait in different paths).

The intervention consists of 12 45-minute sessions of balance and gait training with a mobile and interactive robot prototype for 4 weeks.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with neurologic acute or chronic disease responsible for gait or balance deficiency
  • Absence of important cognitive or mood disabilities
  • PRACTITIONNERS Minimal 1 year of practice related to balance and gait training in a neurology department

排除标准

  • PATIENTS Minors or patients older than 80 years, Weight more than 150 kg, Measuring less than 150 cm or more than190 cm, pregnant and lactating women, cognitive or major mood disorders Being unable to deliver their consent; Protected adults and persons deprived of liberty.
  • PRACTITIONERS Having received information about the robot prototype prior to the study ; Have less than 1 year of practice related to balance and gait training in a neurology department; Protected adults and persons deprived of liberty.

研究组 & 干预措施

Robot

Experimental

ROBOT PROTOTYPE

干预措施: ROBOT PROTOTYPE (Other)

结局指标

主要结局

Social acceptability of robot prototype for patient

时间窗: Comparison of evaluations at baseline and up to 5 months

This assessment is based on classical models of social acceptability (cf. references). It is carried out through semi-directive interviews with patients done before and atfer the use of the prototype (to study the acceptance process in the medium term).

次要结局

  • Evolution of the patient's self perception(Comparison of evaluations at baseline and up to 1 months)
  • Social acceptability of robot prototype for practitioner(Comparison of evaluations at baseline and up to 5 months)

研究者

发起方
Rennes University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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