Nervous System DiseasesNCT04896333
Acceptability in Dialogues With the Robot EBO
An observational study of Nervous System Diseases, run by University of Extremadura at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Nervous System Diseases
- What is being tested?
- Interaction and exposure with the Robot EBO
- How many people
- 6 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jun 2021to 30 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The population of study will be patients with neurological disorders who receive rehabilitation treatment in socio-health centers in Extremadura (Spain).
Who may be able to join
- 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).
Who cannot join
- Severe cognitive impairment
- Language impairment that prevents the use of verbal communication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acceptability in Dialogues Between the Robot EBO and Older Adults
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.
Read the detailed 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.
- Conditions
- Nervous System Diseases
- Being tested
- Interaction and exposure with the Robot EBO
- Keywords
- Nervous System Diseases, acceptability, Robot
- Medical subject headings
- Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interaction and exposure with the Robot EBOOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Interaction and exposure with the Robot EBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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: 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: 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: 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: 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: 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: 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: 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: 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: Measured at the exposure/dialogue of the patient with the robot EBO during the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start15 Jun 2021
- Primary completion30 Jan 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nervous System DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisa María Garrido Ardila, University of Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896333
- Sponsor's protocol ID
- 128/2018
- Status last verified
- Dec 2022
- First submitted
- 2 May 2021
- Last updated
- 16 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability in Dialogues Between the Robot EBO and Older Adults
- ClinicalTrials.gov ID
- NCT04896333
- Acronym / sponsor ID
- 128/2018
- Conditions
- Nervous System Diseases
- Keywords
- Nervous System Diseases, acceptability, Robot
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of ExtremaduraUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 21 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robot interaction | – | Other: Interaction and exposure with the Robot EBOEBO 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The population of study will be patients with neurological disorders who receive rehabilitation treatment in socio-health centers in Extremadura (Spain).
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (2 listed)
- Severe cognitive impairment
- Language impairment that prevents the use of verbal communication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interaction and exposure with the Robot EBOThe 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. | Other | Robot interaction |
Primary outcome
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
Time frame: Measured at the exposure/dialogue of the patient with the robot EBO during the intervention
Robot-user interaction during the conversation measured by recording and viewing the conversation
Robot-user interaction during the conversation: attempts to touch the robot by the patient measured by recording and viewing the conversation
Time frame: Measured at the exposure/dialogue of the patient with the robot EBO during the intervention
Robot-user interaction during the conversation measured by recording and viewing the conversation
Robot-user interaction during the conversation: times the user asks the robot questions measured by recording and viewing the conversation
Time frame: Measured at the exposure/dialogue of the patient with the robot EBO during the intervention
Robot-user interaction during the conversation measured by recording and viewing the conversation.
Robot-user interaction during the conversation: emotions that the conversation provokes in the patient measured by recording and viewing the conversation
Time frame: Measured at the exposure/dialogue of the patient with the robot EBO during the intervention
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)
Robot-user interaction during the conversation: number of total interactions measured by recording and viewing the conversation
Time frame: Measured at the exposure/dialogue of the patient with the robot EBO during the intervention
Robot-user interaction during the conversation measured by recording and viewing the conversation.
Conversation parameters: time of the dialogue measured by the robot's register
Time frame: Measured at the exposure/dialogue of the patient with the robot EBO during the intervention
Conversation parameters measured by the robot's register
Conversation parameters: speed of response measured by the robot's register
Time frame: Measured at the exposure/dialogue of the patient with the robot EBO during the intervention
Conversation parameters (measured by the robot's register): speed of response (time taken by the patient to respond)
Conversation parameters: eye contact and patient's attention measured by the robot's register
Time frame: Measured at the exposure/dialogue of the patient with the robot EBO during the intervention
Conversation parameters (measured by the robot's register): eye contact with the robot and the attention of the patient to follow the conversation.
Conversation parameters: repetition of questions measured by the robot's register
Time frame: Measured at the exposure/dialogue of the patient with the robot EBO during the intervention
Conversation parameters (measured by the robot's register): number of times the patient needed to be asked a question again.
User acceptability of the robot with the Technology Acceptance Model questionnaire
Time frame: Measured at the exposure/dialogue of the patient with the robot EBO during the intervention
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.
User acceptability of the robot measures with an specific designed questionnaire
Time frame: Measured at the exposure/dialogue of the patient with the robot EBO during the intervention
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
Related trials for Nervous System Diseases
RecruitingObservational study
Asprosin and miRNA Expression in Young Women With Metabolic Syndrome
Metabolic Syndrome, Insulin Resistance
Not yet recruiting
Computer-Assisted Vocabulary Intervention for Spanish-English Bilingual Children With Developmental Language Disorder
Developmental Language Disorder
Active, not recruitingPhase 1/2
Gene Transfer Clinical Trial for Infantile and Late Infantile Krabbe Disease Treated Previously With HSCT
Krabbe Disease
Recruiting
Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
Fecal Incontinence
Active, not recruitingObservational study
SCIVAX: Biomarkers of Immune Dysfunction and Vaccine Responsiveness in Chronic SCI
Spinal Cord Injuries, Traumatic Spinal Cord Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nervous System Diseases, run by University of Extremadura at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Measured at the exposure/dialogue of the patient with the robot EBO during the intervention). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2022.