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

NCT03651960 | Completed

• 2 other identifiers: 35RC12_97932015-A00910-49
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke Sequelae

Outcome Measures

Primary Outcomes (1)

• Social acceptability of robot prototype for patient

  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).

  Comparison of evaluations at baseline and up to 5 months

Secondary Outcomes (2)

• Social acceptability of robot prototype for practitioner

  Comparison of evaluations at baseline and up to 5 months

• Evolution of the patient's self perception

  Comparison of evaluations at baseline and up to 1 months

Study Arms (1)

Robot

EXPERIMENTAL

ROBOT PROTOTYPE

Other: ROBOT PROTOTYPE

Interventions

ROBOT PROTOTYPE OTHER

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

Robot

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

CHU de Rennes

Rennes, 35033, France

Location

Related Publications (6)

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

  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

  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

  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

  BACKGROUND

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

  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

  BACKGROUND

Study Officials

• Isabelle BONAN, MD, PhD

  CHU Rennes

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: August 29, 2018
• Study Start: November 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2017
• Last Updated: August 31, 2018

Record last verified: 2018-08

Locations

FR (1)