Clinical trial NCT03651960: Mobile and Interactive Robot's Social Acceptability for Balance and Gait Rehabilitation
Official title: Mobile and Interactive Robot's Social Acceptability for Balance and Gait
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke Sequelae
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

Eligibility criteria: Inclusion Criteria:

* PATIENTS

  * 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Social acceptability of robot prototype for patient
timeFrame: Comparison of evaluations at baseline and up to 5 months
Secondary outcomes:
measure: Social acceptability of robot prototype for practitioner
timeFrame: Comparison of evaluations at baseline and up to 5 months
measure: Evolution of the patient's self perception
timeFrame: Comparison of evaluations at baseline and up to 1 months
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
affiliation: CHU Rennes
name: Isabelle BONAN, MD, PhD
role: STUDY_DIRECTOR
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