Nervous System Diseases Clinical Trial
Official title:
Acceptability in Dialogues Between the Robot EBO and Older Adults
| 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 |
| Verified date | December 2022 |
| Source | University of Extremadura |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| 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. |
| Country | Name | City | State |
|---|---|---|---|
| Spain | University of Extremadura | Cáceres |
| Lead Sponsor | Collaborator |
|---|---|
| University of Extremadura |
Spain,
| 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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