Viewing Study NCT03651960


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Study NCT ID: NCT03651960
Status: COMPLETED
Last Update Posted: 2018-08-31
First Post: 2016-09-13
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Mobile and Interactive Robot's Social Acceptability for Balance and Gait Rehabilitation
Sponsor: Rennes University Hospital
Organization:

Study Overview

Official Title: Mobile and Interactive Robot's Social Acceptability for Balance and Gait
Status: COMPLETED
Status Verified Date: 2018-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ROBO-K
Brief Summary: 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.
Detailed Description: 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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?:

Secondary ID Infos

Secondary ID Type Domain Link View
2015-A00910-49 OTHER Id-RCB View