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| Name | Class |
|---|---|
| Fondazione Don Carlo Gnocchi ETS | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bimanual group | Experimental | In this group, patients will perform a robotic rehabilitation based on bimanual serious games |
|
| Unimanual group | Active Comparator | In this group, patients will perform a robotic rehabilitation based on unimanual serious games |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic rehabilitation using the Arm Light Exoskeleton Rehab Station (ALEx RS) and bimanual serious games | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events and description | Number and description of adverse events related to the provided intervention | through the study, an average of 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in EEG-based Interhemispheric coupling index | Interhemispheric coupling evaluated by means of 64-channel Electroencephalogram (EEG) | Before the intervention, after a 1-hour robotic rehabilitation session |
| Changes in EEG-based Interhemispheric coupling index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Irene Aprile, MD, PhD | Contact | +390633086553 | iaprile@dongnocchi.it |
| Name | Affiliation | Role |
|---|---|---|
| Irene Aprile, MD, PhD | Fondazione Don Carlo Gnocchi ETS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Don Carlo Gnocchi | Recruiting | Rome | 00168 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41179260 | Derived | Mauro MC, Fasano A, Germanotta M, Cortellini L, Insalaco S, Pavan A, Comanducci A, Guglielmelli E, Aprile IG. Aperiodic brain activity changes in patients with stroke following virtual reality-based upper limb robotic rehabilitation: a pilot Randomized Controlled Trial. Front Hum Neurosci. 2025 Oct 17;19:1671804. doi: 10.3389/fnhum.2025.1671804. eCollection 2025. |
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| Robotic rehabilitation using the Arm Light Exoskeleton Rehab Station (ALEx RS) and unimanual serious games | Device | 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. |
|
Interhemispheric coupling evaluated by means of 64-channel Electroencephalogram (EEG) |
| 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) | 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) | 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) | 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) | 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). | 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). | 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). | 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). | 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. | 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. | 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 | 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 | 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. | 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. | 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. | 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. | After a 6-week robotic rehabilitation intervention |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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