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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04896333
Other study ID # 128/2018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 15, 2021
Est. completion date April 30, 2022

Study information

Verified date December 2022
Source University of Extremadura
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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 will be measure. Also the robot-user interaction during the conversation and the conversation parameters will be assessed. The assessements will be done at week 0 and at week 3. During weeks 1 and 2 the robot will be present in the therapeutic activities of the center.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date April 30, 2022
Est. primary completion date January 30, 2022
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - 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). Exclusion Criteria: - Severe cognitive impairment - Language impairment that prevents the use of verbal communication.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Interaction and exposure with the Robot EBO
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.

Locations

Country Name City State
Spain University of Extremadura Cáceres

Sponsors (1)

Lead Sponsor Collaborator
University of Extremadura

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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