The purpose of the study is to test the technical functionality, safety, and feasibility of a bimanual robotic exoskeletal platform and associated serious games in order to offer information on technological and functional advances that will be included in the device's finalization. In addition, a secondary goal will be to assess the therapeutic effects of a rehabilitation therapy based on the bimanual configuration, comparing it to a unimanual treatment delivered on the same platform (using the specific configuration).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
Patients will undergo a bimanual 30-session robotic rehabilitation, using the robot ALEx RS with the bimanual configuration and the related serious games. Each session will last 45 minute. Daily sessions will be provided, five days a week.
Patients will undergo a unimanual 30-session robotic rehabilitation, using the robot ALEx RS with the unimanual configuration and the related serious games.Daily sessions will be provided, five days a week.
Fondazione Don Carlo Gnocchi
Rome, Italy
RECRUITINGIncidence of adverse events and description
Number and description of adverse events related to the provided intervention
Time frame: through the study, an average of 10 months
Changes in EEG-based Interhemispheric coupling index
Interhemispheric coupling evaluated by means of 64-channel Electroencephalogram (EEG)
Time frame: Before the intervention, after a 1-hour robotic rehabilitation session
Changes in EEG-based Interhemispheric coupling index
Interhemispheric coupling evaluated by means of 64-channel Electroencephalogram (EEG)
Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention
Changes in EEG-based Interhemispheric coupling index
Interhemispheric coupling evaluated by means of 64-channel Electroencephalogram (EEG)
Time frame: Before the intervention, 1 week after the end of the 30-session robotic intervention
Changes in EEG-based Connectivity index
Connectivity evaluated by means of 64-channel Electroencephalogram (EEG)
Time frame: Before the intervention, after a 1-hour robotic rehabilitation session
Changes in EEG-based Connectivity index
Connectivity evaluated by means of 64-channel Electroencephalogram (EEG)
Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention
Changes in EEG-based Connectivity index
Connectivity evaluated by means of 64-channel Electroencephalogram (EEG)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Before the intervention, 1 week after the end of the 30-session robotic 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).
Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention
Changes in Fugl-meyer Assessment - Sensory functioning
It is a stroke-specific, sensory impairment index. It ranges from 0 (worse) to 12points (best).
Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention
Changes in Modified Ashworth Scale
It is a validated measure of spasticity. It ranges from 0 (normal) to 4 (rigid limb).
Time frame: 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).
Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention
Changes in Wolf Motor Function Test
It is a validated measure of upper extremity motor ability through timed and functional tasks. The scores ranges from 0 to 75; lower scores are indicative of lower functioning levels.
Time frame: 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.
Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention
Changes in Execution time (seconds) measured with the robot
It is the time (in seconds) required to perform reaching movement using the robot
Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention
Changes in Range of Motion (degrees) measured with the robot
It is the range of motion (measured in degrees) of shoulder and elbow evaluated using the robot
Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention
Changes in Number of velocity peaks measured with the robot
It is a measure of movement smoothness while performing reaching movements with the robot.
Time frame: Before the intervention, after a 6-week robotic rehabilitation intervention
System Usability Scale
It is a self-administered questionnaire to evaluate usability. It ranges from 0 to 100. Higher scores mean better usability.
Time frame: 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.
Time frame: 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.
Time frame: After a 6-week robotic rehabilitation intervention