Neurodegenerative DiseasesNCT05788133
The Role of Humanoid Robot in Neuropsychological Assessment and Cognitive Training.
A study testing treatment and screening by neuropsychological tests on humanoid robot in people with Neurodegenerative Diseases and Stroke, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
Trial summary
The role of humanoid robot in neuropsychological assessment and conducting cognitive training in patients with dementia and severe brain injury" Objectives Use of robotic solutions to carry out diagnostic and rehabilitation intervention in order to recover cognitive and relational performance of patients with dementia… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Neurodegenerative Diseases, Stroke
- What is being tested?
- treatment and screening by neuropsychological tests on humanoid robot
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteItaly
- Study dates
- 28 Sep 2022to 31 Dec 2022
- Phase
- Interventional
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old;
- Patients with moderately impaired cognitive profile;
- Written consent from the legal guardian or the patient himself
Who cannot join
- Patients with language comprehension deficit;
- Patients with disorders of consciousness;
- Patients who are unable to provide a localized and context-appropriate response
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Humanoid Robot in Neuropsychological Assessment and Conducting Cognitive Training in Patients With Dementia and Severe Brain Injury
The role of humanoid robot in neuropsychological assessment and conducting cognitive training in patients with dementia and severe brain injury" Objectives Use of robotic solutions to carry out diagnostic and rehabilitation intervention in order to recover cognitive and relational performance of patients with dementia and severe brain injury.
Study Design. Observational Materials and Methods. Eighty subjects (25 with mild-moderate dementia and 25 patients with severe brain injury) will be enrolled. Patients will undergo neurological examination with collection of all medical history and information on current clinical condition. After that, they will undergo administration of neuropsychological tests via humanoid robot and two months of cognitive rehabilitation sessions.
Read more
Inclusion criteria
- Over 18 years of age;
- Patients with a moderately impaired cognitive profile;
- Written consent from the legal guardian or the patient himself/herself. Exclusion criteria.
- Patients with language comprehension deficits;
- Patients with disorders of consciousness;
- Patients who are unable to provide a localized, context-appropriate response; and All eligible patients will undergo cognitive assessment using the robot at the time of enrollment (T0), and after 2 months of rehabilitation treatment (T1)
Translated with www.DeepL.com/Translator (free version)
Read the detailed description
This is a nonpharmacological interventional study. Clinical and neuropsychological variables will be collected by the robotic system and transferred to a platform where it will be possible to verify the performance achieved by the patient. All patients will be evaluated through the robot with the indispensable support of the neuropsychologist. Patients will be recruited from the outpatient neurology and severe brain injury and neurodegenerative disease departments of the IRCCS Bonino- Pulejo Neurolesi Center in Messina. The rehabilitation treatment period and test administration will be carried out before the start of treatment (T0), after 2 months of treatment (T1).
The project will allow a high technological increase in robotic and informatics solutions available to patients, thanks also to the support of the University, the partnership between complementary companies, an interdisciplinary team capable of designing and developing a new integrated solution for innovative dementia and head injury therapy will be created. Unlike the other existing platforms that mostly use a Web interface and/or application software developed ad hoc, the platform that will be realized is mainly born to be fully integrated and used through an anthropomorphic humanoid robot as a direct communication channel between the content conveyed, the patient and the Tablet device as a reinforcing and feedback element where the patient himself responds and/or interacts with the therapeutic session in progress. In this sense, the robot acts as a performer and receiver of feedback related to the therapeutic process conveyed together with the tablet.
A unique platform of its kind will be developed, capable of managing robots and the self-learning and artificial intelligence platform with the following characteristics:
- Administer therapeutic contents
- Track and store the results of your therapy sessions
- Generate reports and statistics on the results of the training sessions
- Conveying therapeutic contents through robots and software solutions.
- Suggest the best therapy according to the therapeutic objectives of the individual patient Depending on the topic addressed, the operator will be able to choose the categories of exercises related to his own therapeutic objective and then create ad hoc sequences directly from the platform. Each exercise can be parameterised by setting, for example, the level of difficulty, duration, etc. Based on the content conveyed, the robot, for example, will perform the session through verbal or physical interaction with the subject and therefore request feedback which can in turn be performed verbally by the subject or through interaction always through the same Tablet. The results of each exercise and each test will be aggregated according to the chosen goal and stored within a centralized service possibly in the Cloud. Within this system there will be a database with the patient's personal data, the therapeutic objectives defined by the neuropsychologist and the results obtained by the patient. Access to this information will be directed exclusively to the doctor/therapist via Tablet or Web and possibly to the family who, via Web access, will be able to observe the progress of the exercises and therefore the improvement and/or deviation towards the set objective.
The study will be divided into three phases. Phase 1: the personal and clinical data of the patients will be recorded on the tablet directly connected to the robot. The patients will be subjected to the administration of neuropsychological tests, which will be proposed directly by the robot with the support of the neuropsychologist. The robot will acquire the answers (right or wrong), the response time, the execution time of the entire exercise and eventually the number of attempts (if the test foresees it). Starting from this information, a percentage evaluation will be deduced which identifies an overall score.
For each test that will be administered, the tablet connected to the robot will produce a report with incorrect and correct answers and a graph to check the progress.
Phase 2: Subjects will undergo cognitive training using robots 3 times a week for 2 consecutive months. Each session will last one hour, the treatments will take place inside the ward in a setting dedicated to rehabilitation or directly at the patient's bed. The rehabilitation sessions will enhance the cognitive reserve of the target population.
Phase 3: The subjects will again undergo neuropsychological evaluations using the robot and the tablet. A report will be produced with the tests administered and the results.
Materials All neuropsychological tests will be proposed using the "Pepper" robot. Pepper is a humanoid robot one meter twenty tall and weighs 28 kilos. It moves on wheels and interacts with humans also through a tablet located at the height of the torso. Using four directional microphones in its head, it can detect where sounds and voices are coming from and turn its face towards the speaker. These microphones also allow him to analyze the tone of the voice
to interpret the emotional state. A 3D camera and two HD cameras allow him to recognize images, objects and faces instead. Thanks to its three multidirectional wheels it can move in all directions at a maximum speed of three kilometers per hour. He is equipped with 20 motors that allow him to move his head, arms and back.
The tests proposed by the robot will be:
the Mini Mental State Examination (MMSE) which will evaluate the global cognitive profile; Raven's Color Matrices which will assess logical-deductive reasoning skills; Geriatric Depression Scale for mood assessment; WEIGL test for the assessment of executive functions. STUDY POPULATION Sample size Subjects meeting all inclusion criteria will be consecutively enrolled in the study. This research project is a pilot study: the sample will consist of 40 patients with moderate GCA and 40 patients with dementia with a mild and moderate level of cognitive impairment.
Inclusion criteria
- Over 18 years old;
- Patients with moderately impaired cognitive profile; Exclusion criteria
- Patients with language comprehension deficit;
- Patients with disorders of consciousness;
- Patients who are unable to provide a localized and context-appropriate response DURATION OF THE STUDY Overall, the study will last 24 months.
- Conditions
- Neurodegenerative Diseases, Stroke
- Being tested
- treatment and screening by neuropsychological tests on humanoid robot
- Medical subject headings
- Neurodegenerative Diseases, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment and screening by neuropsychological tests on humanoid robotOther
treatment and screening by neuropsychological tests on humanoid robot
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | administration neuropsychological tests with pepper Receives: Other: treatment and screening by neuropsychological tests on humanoid robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
mini mental state examination (MMSE)
administration MMSE with humanoid robot
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start28 Sep 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodegenerative 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia Marino, IRCCS Centro Neurolesi Bonino Pulejo
- Investigators
- silvia marino, MD, Principal investigator, IRCCS Centro Neurolesi Bonino Pulejo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788133
- Sponsor's protocol ID
- TRAIT2021
- Status last verified
- Sep 2022
- First submitted
- 14 Mar 2023
- Last updated
- 28 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Humanoid Robot in Neuropsychological Assessment and Conducting Cognitive Training in Patients With Dementia and Severe Brain Injury
- ClinicalTrials.gov ID
- NCT05788133
- Acronym / sponsor ID
- TRAIT2021
- Conditions
- Neurodegenerative Diseases, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- IRCCS Centro Neurolesi Bonino PulejoUniversity, hospital or other
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 28 Mar 2023 (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.
The role of humanoid robot in neuropsychological assessment and conducting cognitive training in patients with dementia and severe brain injury" Objectives Use of robotic solutions to carry out diagnostic and rehabilitation intervention in order to recover cognitive and relational performance of patients with dementia and severe brain injury.
Study Design. Observational Materials and Methods. Eighty subjects (25 with mild-moderate dementia and 25 patients with severe brain injury) will be enrolled. Patients will undergo neurological examination with collection of all medical history and information on current clinical condition. After that, they will undergo administration of neuropsychological tests via humanoid robot and two months of cognitive rehabilitation sessions.
Inclusion criteria
- Over 18 years of age;
- Patients with a moderately impaired cognitive profile;
- Written consent from the legal guardian or the patient himself/herself. Exclusion criteria.
- Patients with language comprehension deficits;
- Patients with disorders of consciousness;
- Patients who are unable to provide a localized, context-appropriate response; and All eligible patients will undergo cognitive assessment using the robot at the time of enrollment (T0), and after 2 months of rehabilitation treatment (T1)
Translated with www.DeepL.com/Translator (free version)
Detailed description
This is a nonpharmacological interventional study. Clinical and neuropsychological variables will be collected by the robotic system and transferred to a platform where it will be possible to verify the performance achieved by the patient. All patients will be evaluated through the robot with the indispensable support of the neuropsychologist. Patients will be recruited from the outpatient neurology and severe brain injury and neurodegenerative disease departments of the IRCCS Bonino- Pulejo Neurolesi Center in Messina. The rehabilitation treatment period and test administration will be carried out before the start of treatment (T0), after 2 months of treatment (T1).
The project will allow a high technological increase in robotic and informatics solutions available to patients, thanks also to the support of the University, the partnership between complementary companies, an interdisciplinary team capable of designing and developing a new integrated solution for innovative dementia and head injury therapy will be created. Unlike the other existing platforms that mostly use a Web interface and/or application software developed ad hoc, the platform that will be realized is mainly born to be fully integrated and used through an anthropomorphic humanoid robot as a direct communication channel between the content conveyed, the patient and the Tablet device as a reinforcing and feedback element where the patient himself responds and/or interacts with the therapeutic session in progress. In this sense, the robot acts as a performer and receiver of feedback related to the therapeutic process conveyed together with the tablet.
A unique platform of its kind will be developed, capable of managing robots and the self-learning and artificial intelligence platform with the following characteristics:
- Administer therapeutic contents
- Track and store the results of your therapy sessions
- Generate reports and statistics on the results of the training sessions
- Conveying therapeutic contents through robots and software solutions.
- Suggest the best therapy according to the therapeutic objectives of the individual patient Depending on the topic addressed, the operator will be able to choose the categories of exercises related to his own therapeutic objective and then create ad hoc sequences directly from the platform. Each exercise can be parameterised by setting, for example, the level of difficulty, duration, etc. Based on the content conveyed, the robot, for example, will perform the session through verbal or physical interaction with the subject and therefore request feedback which can in turn be performed verbally by the subject or through interaction always through the same Tablet. The results of each exercise and each test will be aggregated according to the chosen goal and stored within a centralized service possibly in the Cloud. Within this system there will be a database with the patient's personal data, the therapeutic objectives defined by the neuropsychologist and the results obtained by the patient. Access to this information will be directed exclusively to the doctor/therapist via Tablet or Web and possibly to the family who, via Web access, will be able to observe the progress of the exercises and therefore the improvement and/or deviation towards the set objective.
The study will be divided into three phases. Phase 1: the personal and clinical data of the patients will be recorded on the tablet directly connected to the robot. The patients will be subjected to the administration of neuropsychological tests, which will be proposed directly by the robot with the support of the neuropsychologist. The robot will acquire the answers (right or wrong), the response time, the execution time of the entire exercise and eventually the number of attempts (if the test foresees it). Starting from this information, a percentage evaluation will be deduced which identifies an overall score.
For each test that will be administered, the tablet connected to the robot will produce a report with incorrect and correct answers and a graph to check the progress.
Phase 2: Subjects will undergo cognitive training using robots 3 times a week for 2 consecutive months. Each session will last one hour, the treatments will take place inside the ward in a setting dedicated to rehabilitation or directly at the patient's bed. The rehabilitation sessions will enhance the cognitive reserve of the target population.
Phase 3: The subjects will again undergo neuropsychological evaluations using the robot and the tablet. A report will be produced with the tests administered and the results.
Materials All neuropsychological tests will be proposed using the "Pepper" robot. Pepper is a humanoid robot one meter twenty tall and weighs 28 kilos. It moves on wheels and interacts with humans also through a tablet located at the height of the torso. Using four directional microphones in its head, it can detect where sounds and voices are coming from and turn its face towards the speaker. These microphones also allow him to analyze the tone of the voice
to interpret the emotional state. A 3D camera and two HD cameras allow him to recognize images, objects and faces instead. Thanks to its three multidirectional wheels it can move in all directions at a maximum speed of three kilometers per hour. He is equipped with 20 motors that allow him to move his head, arms and back.
The tests proposed by the robot will be:
the Mini Mental State Examination (MMSE) which will evaluate the global cognitive profile; Raven's Color Matrices which will assess logical-deductive reasoning skills; Geriatric Depression Scale for mood assessment; WEIGL test for the assessment of executive functions. STUDY POPULATION Sample size Subjects meeting all inclusion criteria will be consecutively enrolled in the study. This research project is a pilot study: the sample will consist of 40 patients with moderate GCA and 40 patients with dementia with a mild and moderate level of cognitive impairment.
Inclusion criteria
- Over 18 years old;
- Patients with moderately impaired cognitive profile; Exclusion criteria
- Patients with language comprehension deficit;
- Patients with disorders of consciousness;
- Patients who are unable to provide a localized and context-appropriate response DURATION OF THE STUDY Overall, the study will last 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Other: treatment and screening by neuropsychological tests on humanoid robotadministration neuropsychological tests with pepper |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years old;
- Patients with moderately impaired cognitive profile;
- Written consent from the legal guardian or the patient himself
Key exclusion criteria (3 listed)
- Patients with language comprehension deficit;
- Patients with disorders of consciousness;
- Patients who are unable to provide a localized and context-appropriate response
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 |
|---|---|---|
| treatment and screening by neuropsychological tests on humanoid robottreatment and screening by neuropsychological tests on humanoid robot | Other | treatment |
Primary outcome
mini mental state examination (MMSE)
Time frame: 2 months
administration MMSE with humanoid robot
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 28 Mar 2023.
- Individual participant dataSharing planned: No. corresponding author
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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.
silvia marino, MD principal investigator
IRCCS Centro Neurolesi Bonino Pulejo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing treatment and screening by neuropsychological tests on humanoid robot in people with Neurodegenerative Diseases and Stroke, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
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 3 inclusion and 3 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 28 Mar 2023. 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 Italy. 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?
mini mental state examination (MMSE) (time frame: 2 months). 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 28 Mar 2023.