NCT04896333

Brief Summary

This is a descriptive observational study (first results cross-sectional study, second results longitudinal study). The participants of the study will be exposed to a dialogue with the robot EBO. The user and the therapist's acceptability of the robot, the robot-user interaction during the conversation and the conversation parameters will be assessed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 21, 2021

Completed
25 days until next milestone

Study Start

First participant enrolled

June 15, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

December 16, 2022

Status Verified

December 1, 2022

Enrollment Period

8 months

First QC Date

May 2, 2021

Last Update Submit

December 15, 2022

Conditions

Keywords

Nervous System DiseasesacceptabilityRobot

Outcome Measures

Primary Outcomes (11)

  • Robot-user interaction during the conversation: Conversation topic that most motivates the user or with which the user most interacts with the robot measured by recording and viewing the conversation

    Robot-user interaction during the conversation measured by recording and viewing the conversation

    Measured at the exposure/dialogue of the patient with the robot EBO during the intervention

  • Robot-user interaction during the conversation: attempts to touch the robot by the patient measured by recording and viewing the conversation

    Robot-user interaction during the conversation measured by recording and viewing the conversation

    Measured at the exposure/dialogue of the patient with the robot EBO during the intervention

  • Robot-user interaction during the conversation: times the user asks the robot questions measured by recording and viewing the conversation

    Robot-user interaction during the conversation measured by recording and viewing the conversation.

    Measured at the exposure/dialogue of the patient with the robot EBO during the intervention

  • Robot-user interaction during the conversation: emotions that the conversation provokes in the patient measured by recording and viewing the conversation

    Robot-user interaction during the conversation measured by recording and viewing the conversation: emotions that the conversation provokes in the user (Standard, happy, sad, angry)

    Measured at the exposure/dialogue of the patient with the robot EBO during the intervention

  • Robot-user interaction during the conversation: number of total interactions measured by recording and viewing the conversation

    Robot-user interaction during the conversation measured by recording and viewing the conversation.

    Measured at the exposure/dialogue of the patient with the robot EBO during the intervention

  • Conversation parameters: time of the dialogue measured by the robot's register

    Conversation parameters measured by the robot's register

    Measured at the exposure/dialogue of the patient with the robot EBO during the intervention

  • Conversation parameters: speed of response measured by the robot's register

    Conversation parameters (measured by the robot's register): speed of response (time taken by the patient to respond)

    Measured at the exposure/dialogue of the patient with the robot EBO during the intervention

  • Conversation parameters: eye contact and patient's attention measured by the robot's register

    Conversation parameters (measured by the robot's register): eye contact with the robot and the attention of the patient to follow the conversation.

    Measured at the exposure/dialogue of the patient with the robot EBO during the intervention

  • Conversation parameters: repetition of questions measured by the robot's register

    Conversation parameters (measured by the robot's register): number of times the patient needed to be asked a question again.

    Measured at the exposure/dialogue of the patient with the robot EBO during the intervention

  • User acceptability of the robot with the Technology Acceptance Model questionnaire

    User acceptability of the robot measured with the Technology Acceptance Model. This scale has good validity and reliability, with a Cronbach's alpha value above 0.8 (Alenazy, Mugahed Al-Rahmi, \& Khan, 2019). It assesses the following dimensions relating to the technology product: * Perceived ease of use: the extent to which users believe that using a particular system would improve their performance. * Perceived usefulness: the extent to which the individual believes that using the system will be effortless * Attitude towards use * Relevance A higher scores indicates a higher acceptability.

    Measured at the exposure/dialogue of the patient with the robot EBO during the intervention

  • User acceptability of the robot measures with an specific designed questionnaire

    User acceptability of the robot measured with a questionnaire designed by the authors of the study. The questionnaire has 10 items that evaluate the acceptability of the robot by the user. This 10 questions have 3 choice answer with the options being yes, no, I don not know. There is one open question to collect qualitative data a¡regarding the dialogue and the acceptability.

    Measured at the exposure/dialogue of the patient with the robot EBO during the intervention

Study Arms (1)

Robot interaction

EBO is a robotic platform consisting of the following: A screen display capable of generating emotions (sadness, joy, neutral, anger, disgust and surprise), RGB camera, basic navigation system. EBO must be controlled by a teleoperator through a user-friendly and simple interface. Communication should be as immediate as possible, as well as predefined. In any case, the dialogue flow can be modified if necessary. The interface, at the same time, allows the possibility of sending emotions and small movements to the robot, to accompany the dialogue with certain elements of emotionality. The experiment replicates the Wizard of Oz technique. In this technique, the human tele-operator controls the robot without the person noticing it as he is in another room. For this purpose, a user interface will be displayed on the teleoperator's terminal and the commands will be reproduced by the EBO robot

Other: Interaction and exposure with the Robot EBO

Interventions

The participants will interact with the Robot EBO. The robot will be control by an operator that will conduct a dialogue. The dialogue will include questions related to the social, leisure, activities of daily living and informative areas.

Robot interaction

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population of study will be patients with neurological disorders who receive rehabilitation treatment in socio-health centers in Extremadura (Spain).

You may qualify if:

  • Users of socio-health centers in Extremadura (Spain).
  • Patients with neurological pathology diagnosed by a specialist doctor.
  • Over 65 years of age
  • Minimental State Examination with a score greater than or equal to 21 (mild-moderate cognitive impairment).

You may not qualify if:

  • Severe cognitive impairment
  • Language impairment that prevents the use of verbal communication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Extremadura

Cáceres, 10003, Spain

Location

MeSH Terms

Conditions

Nervous System Diseases

Interventions

Drug Interactions

Intervention Hierarchy (Ancestors)

Pharmacological PhenomenaPharmacological and Toxicological PhenomenaPhysiological Phenomena

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

May 2, 2021

First Posted

May 21, 2021

Study Start

June 15, 2021

Primary Completion

January 30, 2022

Study Completion

April 30, 2022

Last Updated

December 16, 2022

Record last verified: 2022-12

Locations