StrokeiMotoreNCT05238389
AI-based Upper Limb Rehabilitation Therapy With MOTORE
A study testing AI-based upper limb robotic therapy in people with Stroke, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial summary
Stroke is a common disease with a high disabling impact; it is the world's second leading cause of death and the third leading cause of disability. Robotic therapy has been proposed as a viable approach for the rehabilitation of the upper limb, as a way to increase the amount and the intensity of the therapy, and to… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- AI-based upper limb robotic therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2022to 30 Mar 2023
- 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
- first ischemic or hemorrhagic stroke (verified by MRI or CT);
- time since stroke onset between 1 and 6 months (subacute phase)
- cognitive abilities adequate to understand the experiments and the follow instructions
- upper limb impairment (Fugl-Meyer Assessment - Upper Extremity score ≤58);
Who cannot join
- fixed contractions in the affected limb (ankylosis, Modified Ashworth Scale equal to 4);
- inability to understand the instructions required for the study;
- behavioral disorders that may influence therapeutic activity;
- other orthopedic or neurological diseases
- inability or unwillingness to provide informed consent.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Don Carlo Gnocchi, Santa Maria della Provvidenza Center
Rome, 00168
About this study
Official title: Intelligent Robot-mediated Therapy With the MOTORE Device
Stroke is a common disease with a high disabling impact; it is the world's second leading cause of death and the third leading cause of disability. Robotic therapy has been proposed as a viable approach for the rehabilitation of the upper limb, as a way to increase the amount and the intensity of the therapy, and to standardize the treatment. However, robotic technologies have not yet been used to their full potential in terms of tailoring rehabilitation paths and monitoring the response to treatments. The main goal of the study is to use AI algorithms to (a) predict the recovery of the patients and (b) suggest exercises and parameters to improve the outcomes of the treatment.
- Conditions
- Stroke
- Being tested
- AI-based upper limb robotic therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-based upper limb robotic therapyDevice
Also called MOTORE
Patients will be treated using MOTORE, a robotic device that allows passive, active, and active-assistive planar movements of the shoulder and elbow joints. The intervention will consist of 30 sessions, 1 per day and 5 per week. Therefore, each patient will be treated for 6 weeks
The parameters of the serious games will be proposed by a Decision Support System (DSS), based on an AI-based algorithm trained using data collected during a previous Randomized Controlled Trial.
The DSS will be fed, at the enrollment, with patient's demographics, clinical characteristics, clinical scales and kinematic/kinetic data measured by the robot during an evaluation session (unassisted reaching movements) and updated every 2 sessions with kinematic/kinetic data only, to tailor the treatment to the patient's current abilities.
The therapists will be free to use or not the suggested parameters, on the basis of their previous experience with the robot (over 3 years).
| Study group | Role | What they receive |
|---|---|---|
| Robotic group | Experimental | In the robotic group, patients will undergo a 30-session upper limb robotic rehabilitation using the device MOTORE. Receives: Device: AI-based upper limb robotic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between the physiotherapists and the decision support system
The number of times a physiotherapist refuses to accept the parameters proposed
Measured: Through the study, an average of 10 months
System Usability Scale
It is a self-administered questionnaire to evaluate usability. It ranges from 0 to 100. Higher scores mean better usability.
Measured: After a 6-week robotic rehabilitation intervention
Technology Acceptance Model (TAM)
It is a self-administered questionnaire to evaluate the acceptance of the provided.
It comprises several questions rated on a 7-point likert scale.
Measured: After a 6-week robotic rehabilitation intervention
Likert for Satisfaction
Satisfaction will be assessed using a 11-point likert scale. It ranges from 0 to 10. Higher scores mean higher satisfaction.
Measured: After a 6-week robotic rehabilitation intervention
Secondary outcomes (33)
Changes in Fugl-meyer Assessment Upper Extremity motor functioning
It is a stroke-specific, performance-based impairment index. It ranges from 0 (hemiplegia) to 66 points (normal).
Measured: Before the intervention, after a 3-week robotic rehabilitation intervention
Changes in Fugl-meyer Assessment Upper Extremity motor functioning
It is a stroke-specific, performance-based impairment index. It ranges from 0 (hemiplegia) to 66 points (normal).
Measured: Before the intervention, after a 6-week robotic rehabilitation intervention
Changes in Box and Block test (BBT)
The BBT is a standard measure for evaluating manual dexterity. The participants grasp and transfer one-inch square blocks from one compartment to the other, transferring as many as possible. The number of blocks transferred from one side to the other within 1 min is recorded.
Measured: Before the intervention, after a 3-week robotic rehabilitation intervention
Changes in Box and Block test (BBT)
The BBT is a standard measure for evaluating manual dexterity. The participants grasp and transfer one-inch square blocks from one compartment to the other, transferring as many as possible. The number of blocks transferred from one side to the other within 1 min is recorded.
Measured: Before the intervention, after a 6-week robotic rehabilitation intervention
Changes in Action Research Arm Test (ARAT)
It is a valid measure of upper-extremity functional limitation. The total score on the ARAT ranges from 0 to 57, with the lowest score indicating that no movements can be performed, and the upper score indicating normal performance.
Measured: Before the intervention, after a 3-week robotic rehabilitation intervention
Changes in Action Research Arm Test (ARAT)
It is a valid measure of upper-extremity functional limitation. The total score on the ARAT ranges from 0 to 57, with the lowest score indicating that no movements can be performed, and the upper score indicating normal performance.
Measured: Before the intervention, after a 6-week robotic rehabilitation intervention
Change in Medical Research Council (MRC)
It is a validated measure of strength clinically measured. It ranges from 0, paralysis, to 5, normal strength.
Measured: Before the intervention, after a 3-week robotic rehabilitation intervention
Change in Medical Research Council (MRC)
It is a validated measure of strength clinically measured. It ranges from 0, paralysis, to 5, normal strength.
Measured: Before the intervention, after a 6-week robotic rehabilitation intervention
Change in Frenchay Arm Test
The Frenchay Arm Test (FAT) is a measure of upper extremity proximal motor control and dexterity during activities of daily living in patients with upper limb impairments. The total scores range from 0 to 5 (normal performance).
Measured: Before the intervention, after a 3-week robotic rehabilitation intervention
Change in Frenchay Arm Test
The Frenchay Arm Test (FAT) is a measure of upper extremity proximal motor control and dexterity during activities of daily living in patients with upper limb impairments. The total scores range from 0 to 5 (normal performance).
Measured: Before the intervention, after a 6-week robotic rehabilitation intervention
Change in Modified Ashworth Scale
It is a validated measure of spasticity. It ranges from 0 (normal) to 4 (rigid limb).
Measured: Before the intervention, after a 3-week robotic rehabilitation intervention
Change in Modified Ashworth Scale
It is a validated measure of spasticity. It ranges from 0 (normal) to 4 (rigid limb).
Measured: Before the intervention, after a 6-week robotic rehabilitation intervention
Changes in Motricity Index for upper extremity
It is a validated measure of upper limb strength. It ranges from 0 (worse) to 100 (normal strength).
Measured: Before the intervention, after a 3-week robotic rehabilitation intervention
Changes in Motricity Index for upper extremity
It is a validated measure of upper limb strength. It ranges from 0 (worse) to 100 (normal strength).
Measured: Before the intervention, after a 6-week robotic rehabilitation intervention
Changes in Numeric Rating Scale for pain
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale, from 0 (no pain) to 10 (worst pain imaginable).
Measured: Before the intervention, after a 3-week robotic rehabilitation intervention
Changes in Numeric Rating Scale for pain
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale, from 0 (no pain) to 10 (worst pain imaginable).
Measured: Before the intervention, after a 6-week robotic rehabilitation intervention
Changes in Neuropathic Pain 4 Questions (DN4)
It is a validated clinician-administered screening tool for neuropathic pain. It ranges from 0 to 10; higher values means higher neuropathic pain probability.
Measured: Before the intervention, after a 3-week robotic rehabilitation intervention
Changes in Neuropathic Pain 4 Questions (DN4)
It is a validated clinician-administered screening tool for neuropathic pain. It ranges from 0 to 10; higher values means higher neuropathic pain probability.
Measured: Before the intervention, after a 6-week robotic rehabilitation intervention
Changes in Modified Barthel Index
The modified is an ordinal scale used to measure performance in activities of daily living. It ranges from 0 to 100, with lower scores indicating increased disability.
Measured: Before the intervention, after a 3-week robotic rehabilitation intervention
Changes in Modified Barthel Index
The modified is an ordinal scale used to measure performance in activities of daily living. It ranges from 0 to 100, with lower scores indicating increased disability.
Measured: Before the intervention, after a 6-week robotic rehabilitation intervention
Changes in 36-Item Short Form Survey (SF-36)
The 36-Item Short Form Survey (SF-36) is a self-reported measure of health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
The scores are: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health.
Moreover, two composite scores, i.e., the Physical Composite Score and the Mental Composite Score, both ranging from 0 to 100, will be considered.
Measured: Before the intervention, after a 6-week robotic rehabilitation intervention
Changes in the Duration Index.
The kinematics of the end-effector of the robot will be acquired during reaching tasks performed by the patient without any assistance from the device. Specifically, "Duration" is the time required to complete the task. It is measured in seconds.
Measured: Before the intervention, after a 3-week robotic rehabilitation intervention
Changes in the Duration Index.
The kinematics of the end-effector of the robot will be acquired during reaching tasks performed by the patient without any assistance from the device. Specifically, "Duration" is the time required to complete the task. It is measured in seconds.
Measured: Before the intervention, after a 6-week robotic rehabilitation intervention
Changes in Velocity_mean Index.
The kinematics of the end-effector of the robot will be acquired during reaching tasks performed by the patient without any assistance from the device. Specifically, "Velocity_mean" is the average velocity of the device during the test. It is measured in m/s.
Measured: Before the intervention, after a 3-week robotic rehabilitation intervention
Changes in Velocity_mean Index.
The kinematics of the end-effector of the robot will be acquired during reaching tasks performed by the patient without any assistance from the device. Specifically, "Velocity_mean" is the average velocity of the device during the test. It is measured in m/s.
Measured: Before the intervention, after a 6-week robotic rehabilitation intervention
Changes in the Length_tot Index
The kinematics of the end-effector of the robot will be acquired during reaching tasks performed by the patient without any assistance from the device. Specifically, "Length_tot" is the global length of the path travelled by the subject during center-out movements. It is measured in meters and it ranges from 0 (no movement) to 2.808 m (patient can fully perform the entire task);
Measured: Before the intervention, after a 3-week robotic rehabilitation intervention
Changes in the Length_tot Index
The kinematics of the end-effector of the robot will be acquired during reaching tasks performed by the patient without any assistance from the device. Specifically, "Length_tot" is the global length of the path travelled by the subject during center-out movements. It is measured in meters and it ranges from 0 (no movement) to 2.808 m (patient can fully perform the entire task);
Measured: Before the intervention, after a 6-week robotic rehabilitation intervention
Changes in the Score Index.
The kinematics of the end-effector of the robot will be acquired during reaching tasks performed by the patient without any assistance from the device. Specifically, "Score" is the mean of the ratios between the actual distance covered by the patients and the required distance to be travelled, computed for each required movement; it ranges from 0 (no movement) to 10 (the patient can fully perform the required task). It is a dimensionless index.
Measured: Before the intervention, after a 3-week robotic rehabilitation intervention
Changes in the Score Index.
The kinematics of the end-effector of the robot will be acquired during reaching tasks performed by the patient without any assistance from the device. Specifically, "Score" is the mean of the ratios between the actual distance covered by the patients and the required distance to be travelled, computed for each required movement; it ranges from 0 (no movement) to 10 (the patient can fully perform the required task). It is a dimensionless index.
Measured: Before the intervention, after a 6-week robotic rehabilitation intervention
Changes in the Work_tan Index.
The kinematics of the end-effector of the robot will be acquired during reaching tasks performed by the patient without any assistance from the device. Specifically, "Work_tan" is the amount of total work directed towards the target. It is measured in Joules.
Measured: Before the intervention, after a 3-week robotic rehabilitation intervention
Changes in the Work_tan Index.
The kinematics of the end-effector of the robot will be acquired during reaching tasks performed by the patient without any assistance from the device. Specifically, "Work_tan" is the amount of total work directed towards the target. It is measured in Joules.
Measured: Before the intervention, after a 6-week robotic rehabilitation intervention
Changes in kinetic parameters: Force (N) towards 8 targets
The kinetics of the end-effector of the robot will be measured by the robot during reaching tasks performed by the patient against the device. The outcome will be the maximum values towards 8 targets.
Measured: Before the intervention, after a 3-week robotic rehabilitation intervention
Changes in kinetic parameters: Force (N) towards 8 targets
The kinetics of the end-effector of the robot will be measured by the robot during reaching tasks performed by the patient against the device. The outcome will be the maximum values towards 8 targets.
Measured: Before the intervention, after a 6-week robotic rehabilitation intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start1 Jun 2022
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irene Giovanna Aprile, Fondazione Don Carlo Gnocchi ETS
- Investigators
- Irene Aprile, MD, PhD, Principal investigator, Fondazione Don Carlo Gnocchi ETS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238389
- Sponsor's protocol ID
- FDG-iMotore
- Acronym
- iMotore
- Status last verified
- Feb 2024
- First submitted
- 25 Jan 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intelligent Robot-mediated Therapy With the MOTORE Device
- ClinicalTrials.gov ID
- NCT05238389
- Acronym / sponsor ID
- iMotore / FDG-iMotore
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 14 Feb 2022 (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.
Stroke is a common disease with a high disabling impact; it is the world's second leading cause of death and the third leading cause of disability. Robotic therapy has been proposed as a viable approach for the rehabilitation of the upper limb, as a way to increase the amount and the intensity of the therapy, and to standardize the treatment. However, robotic technologies have not yet been used to their full potential in terms of tailoring rehabilitation paths and monitoring the response to treatments. The main goal of the study is to use AI algorithms to (a) predict the recovery of the patients and (b) suggest exercises and parameters to improve the outcomes of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic group | Experimental | Device: AI-based upper limb robotic therapyIn the robotic group, patients will undergo a 30-session upper limb robotic rehabilitation using the device MOTORE. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- first ischemic or hemorrhagic stroke (verified by MRI or CT);
- time since stroke onset between 1 and 6 months (subacute phase)
- cognitive abilities adequate to understand the experiments and the follow instructions
- upper limb impairment (Fugl-Meyer Assessment - Upper Extremity score ≤58);
Key exclusion criteria (5 listed)
- fixed contractions in the affected limb (ankylosis, Modified Ashworth Scale equal to 4);
- inability to understand the instructions required for the study;
- behavioral disorders that may influence therapeutic activity;
- other orthopedic or neurological diseases
- inability or unwillingness to provide informed consent.
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 |
|---|---|---|
| AI-based upper limb robotic therapyAlso: MOTOREPatients will be treated using MOTORE, a robotic device that allows passive, active, and active-assistive planar movements of the shoulder and elbow joints. The intervention will consist of 30 sessions, 1 per day and 5 per week. Therefore, each patient will be treated for 6 weeks The parameters of the serious games will be proposed by a Decision Support System (DSS), based on an AI-based algorithm trained using data collected during a previous Randomized Controlled Trial. The DSS will be fed, at the enrollment, with patient's demographics, clinical characteristics, clinical scales and kinematic/kinetic data measured by the robot during an evaluation session (unassisted reaching movements) and updated every 2 sessions with kinematic/kinetic data only, to tailor the treatment to the patient's current abilities. The therapists will be free to use or not the suggested parameters, on the basis of their previous experience with the robot (over 3 years). | Device | Robotic group |
Primary outcome
Agreement between the physiotherapists and the decision support system
Time frame: Through the study, an average of 10 months
The number of times a physiotherapist refuses to accept the parameters proposed
System Usability Scale
Time frame: After a 6-week robotic rehabilitation intervention
It is a self-administered questionnaire to evaluate usability. It ranges from 0 to 100. Higher scores mean better usability.
Technology Acceptance Model (TAM)
Time frame: After a 6-week robotic rehabilitation intervention
It is a self-administered questionnaire to evaluate the acceptance of the provided. It comprises several questions rated on a 7-point likert scale.
Likert for Satisfaction
Time frame: After a 6-week robotic rehabilitation intervention
Satisfaction will be assessed using a 11-point likert scale. It ranges from 0 to 10. Higher scores mean higher satisfaction.
33 secondary outcomes
Changes in Fugl-meyer Assessment Upper Extremity motor functioning
Time frame: Before the intervention, after a 3-week robotic rehabilitation intervention
Changes in Fugl-meyer Assessment Upper Extremity motor functioning
Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention
Changes in Box and Block test (BBT)
Time frame: Before the intervention, after a 3-week robotic rehabilitation intervention
Changes in Box and Block test (BBT)
Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention
Changes in Action Research Arm Test (ARAT)
Time frame: Before the intervention, after a 3-week robotic rehabilitation intervention
Changes in Action Research Arm Test (ARAT)
Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention
Change in Medical Research Council (MRC)
Time frame: Before the intervention, after a 3-week robotic rehabilitation intervention
Change in Medical Research Council (MRC)
Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention
Change in Frenchay Arm Test
Time frame: Before the intervention, after a 3-week robotic rehabilitation intervention
Change in Frenchay Arm Test
Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention
Change in Modified Ashworth Scale
Time frame: Before the intervention, after a 3-week robotic rehabilitation intervention
Change in Modified Ashworth Scale
Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention
Changes in Motricity Index for upper extremity
Time frame: Before the intervention, after a 3-week robotic rehabilitation intervention
Changes in Motricity Index for upper extremity
Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention
Changes in Numeric Rating Scale for pain
Time frame: Before the intervention, after a 3-week robotic rehabilitation intervention
Changes in Numeric Rating Scale for pain
Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention
Changes in Neuropathic Pain 4 Questions (DN4)
Time frame: Before the intervention, after a 3-week robotic rehabilitation intervention
Changes in Neuropathic Pain 4 Questions (DN4)
Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention
Changes in Modified Barthel Index
Time frame: Before the intervention, after a 3-week robotic rehabilitation intervention
Changes in Modified Barthel Index
Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention
Changes in 36-Item Short Form Survey (SF-36)
Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention
Changes in the Duration Index.
Time frame: Before the intervention, after a 3-week robotic rehabilitation intervention
Changes in the Duration Index.
Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention
Changes in Velocity_mean Index.
Time frame: Before the intervention, after a 3-week robotic rehabilitation intervention
Changes in Velocity_mean Index.
Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention
Changes in the Length_tot Index
Time frame: Before the intervention, after a 3-week robotic rehabilitation intervention
Changes in the Length_tot Index
Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention
Changes in the Score Index.
Time frame: Before the intervention, after a 3-week robotic rehabilitation intervention
Changes in the Score Index.
Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention
Changes in the Work_tan Index.
Time frame: Before the intervention, after a 3-week robotic rehabilitation intervention
Changes in the Work_tan Index.
Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention
Changes in kinetic parameters: Force (N) towards 8 targets
Time frame: Before the intervention, after a 3-week robotic rehabilitation intervention
Changes in kinetic parameters: Force (N) towards 8 targets
Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention
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 Feb 2024.
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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.
Irene Aprile, MD, PhD principal investigator
Fondazione Don Carlo Gnocchi ETS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-based upper limb robotic therapy in people with Stroke, run by Fondazione Don Carlo Gnocchi ETS 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 4 inclusion and 5 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 Feb 2024. 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?
Agreement between the physiotherapists and the decision support system (time frame: Through the study, an average of 10 months). The study lists 4 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 28 Feb 2024; AzTrials last refreshed its copy on 6 Nov 2026.