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

NCT ID: NCT03651960

Last Updated: 2018-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-12-31

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.

Conditions

Stroke Sequelae

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Robot

ROBOT PROTOTYPE

Group Type: EXPERIMENTAL

ROBOT PROTOTYPE

Intervention Type: OTHER

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

Interventions

ROBOT PROTOTYPE

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Isabelle BONAN, MD, PhD

Role: STUDY_DIRECTOR

CHU Rennes

Locations

CHU de Rennes

Rennes, , France

Countries

France

References

Davis, F.D. (1989). Perceived usefulness, perceived ease of use, and user acceptance of information technology. MIS Quartely, 13 (3) : 319-340.

Reference Type: BACKGROUND

Venkastesh, V., Morris, M.G., Davis, G.B. & Davis, F.D. (2003). User acceptance of information technology: toward a unified view. Mis Quartely, 27 (3), 425-478

Reference Type: BACKGROUND

Heerink, M., Kröse, B., Evers, V., & Wielinga, B. (2010). Assessing acceptance of assistive social agent technology by older adults: the Almere Model. International Journal of Social Robotics, 2(4), 361-375

Reference Type: BACKGROUND

Hamner, M. & Qazi, R. (2008). Expanding the technology acceptance model to examine personal computing technology utilization in government agencies in developing countries. Government Information Quaterly, 26(1), 128-136

Reference Type: BACKGROUND

King, W.R., & He, J. (2006). A meta-analysis of the technology acceptance model. Information and Management, 43(6), 740-755

Reference Type: BACKGROUND

Legris, P., Ingham, J., & Collerette, P. (2003). Why do people use information technology? A critical review of the technology acceptance model. Information and Management, 40(3), 191-204

Reference Type: BACKGROUND

Other Identifiers

2015-A00910-49

Identifier Type: OTHER

Identifier Source: secondary_id

35RC12_9793

Identifier Type: -

Identifier Source: org_study_id