Clinical trial NCT05238389: AI-based Upper Limb Rehabilitation Therapy With MOTORE
Official title: Intelligent Robot-mediated Therapy With the MOTORE Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2022-02-14
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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);

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Agreement between the physiotherapists and the decision support system
timeFrame: Through the study, an average of 10 months
measure: System Usability Scale
timeFrame: After a 6-week robotic rehabilitation intervention
measure: Technology Acceptance Model (TAM)
timeFrame: After a 6-week robotic rehabilitation intervention
measure: Likert for Satisfaction
timeFrame: After a 6-week robotic rehabilitation intervention
Secondary outcomes:
measure: Changes in Fugl-meyer Assessment Upper Extremity motor functioning
timeFrame: Before the intervention, after a 3-week robotic rehabilitation intervention
measure: Changes in Fugl-meyer Assessment Upper Extremity motor functioning
timeFrame: Before the intervention, after a 6-week robotic rehabilitation intervention
measure: Changes in Box and Block test (BBT)
timeFrame: Before the intervention, after a 3-week robotic rehabilitation intervention
measure: Changes in Box and Block test (BBT)
timeFrame: Before the intervention, after a 6-week robotic rehabilitation intervention
measure: Changes in Action Research Arm Test (ARAT)
timeFrame: Before the intervention, after a 3-week robotic rehabilitation intervention
measure: Changes in Action Research Arm Test (ARAT)
timeFrame: Before the intervention, after a 6-week robotic rehabilitation intervention
measure: Change in Medical Research Council (MRC)
timeFrame: Before the intervention, after a 3-week robotic rehabilitation intervention
measure: Change in Medical Research Council (MRC)
timeFrame: Before the intervention, after a 6-week robotic rehabilitation intervention
measure: Change in Frenchay Arm Test
timeFrame: Before the intervention, after a 3-week robotic rehabilitation intervention
measure: Change in Frenchay Arm Test
timeFrame: Before the intervention, after a 6-week robotic rehabilitation intervention
measure: Change in Modified Ashworth Scale
timeFrame: Before the intervention, after a 3-week robotic rehabilitation intervention
measure: Change in Modified Ashworth Scale
timeFrame: Before the intervention, after a 6-week robotic rehabilitation intervention
measure: Changes in Motricity Index for upper extremity
timeFrame: Before the intervention, after a 3-week robotic rehabilitation intervention
measure: Changes in Motricity Index for upper extremity
timeFrame: Before the intervention, after a 6-week robotic rehabilitation intervention
measure: Changes in Numeric Rating Scale for pain
timeFrame: Before the intervention, after a 3-week robotic rehabilitation intervention
measure: Changes in Numeric Rating Scale for pain
timeFrame: Before the intervention, after a 6-week robotic rehabilitation intervention
measure: Changes in Neuropathic Pain 4 Questions (DN4)
timeFrame: Before the intervention, after a 3-week robotic rehabilitation intervention
measure: Changes in Neuropathic Pain 4 Questions (DN4)
timeFrame: Before the intervention, after a 6-week robotic rehabilitation intervention
measure: Changes in Modified Barthel Index
timeFrame: Before the intervention, after a 3-week robotic rehabilitation intervention
measure: Changes in Modified Barthel Index
timeFrame: Before the intervention, after a 6-week robotic rehabilitation intervention
measure: Changes in 36-Item Short Form Survey (SF-36)
timeFrame: Before the intervention, after a 6-week robotic rehabilitation intervention
measure: Changes in the Duration Index.
timeFrame: Before the intervention, after a 3-week robotic rehabilitation intervention
measure: Changes in the Duration Index.
timeFrame: Before the intervention, after a 6-week robotic rehabilitation intervention
measure: Changes in Velocity_mean Index.
timeFrame: Before the intervention, after a 3-week robotic rehabilitation intervention
measure: Changes in Velocity_mean Index.
timeFrame: Before the intervention, after a 6-week robotic rehabilitation intervention
measure: Changes in the Length_tot Index
timeFrame: Before the intervention, after a 3-week robotic rehabilitation intervention
measure: Changes in the Length_tot Index
timeFrame: Before the intervention, after a 6-week robotic rehabilitation intervention
measure: Changes in the Score Index.
timeFrame: Before the intervention, after a 3-week robotic rehabilitation intervention
measure: Changes in the Score Index.
timeFrame: Before the intervention, after a 6-week robotic rehabilitation intervention
measure: Changes in the Work_tan Index.
timeFrame: Before the intervention, after a 3-week robotic rehabilitation intervention
measure: Changes in the Work_tan Index.
timeFrame: Before the intervention, after a 6-week robotic rehabilitation intervention
measure: Changes in kinetic parameters: Force (N) towards 8 targets
timeFrame: Before the intervention, after a 3-week robotic rehabilitation intervention
measure: Changes in kinetic parameters: Force (N) towards 8 targets
timeFrame: Before the intervention, after a 6-week robotic rehabilitation intervention
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Don Carlo Gnocchi, Santa Maria della Provvidenza Center
Study officials:
affiliation: Fondazione Don Carlo Gnocchi Onlus
name: Irene Aprile, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: