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| ID | Type | Description | Link |
|---|---|---|---|
| PAR FAS 2007-2013 | Other Grant/Funding Number | MIUR - MISE - REGIONE TOSCANA DGRT 758/2013 |
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| Name | Class |
|---|---|
| Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna | OTHER |
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The study is designed as an open-label pilot study with a pre-post treatment assessment.
The enrolled patients will undergo a rehabilitation program aimed at recovering upper-limb motor function. The entire cohort will receive the hospital's standard rehabilitative care, and the experimental treatment will be provided as an add-on. All participants will complete 7 sessions of robot-assisted rehabilitation (consecutive where possible, for a maximum of 5 sessions per week), with the NESM-α robotic exoskeleton. Robotic treatment consists of sessions focused on shoulder and elbow mobilization and functional movements. The range of motion is adjusted in each session so that the treatment is tailored to the patient's recovery. The level of assistance is tuned during the first session to be tailored on patient residual capabilities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NESM-alpha | Experimental | Patients with severe or moderate upper-limb motor impairment (UEFM ≤ 42) receive 7 sessions of robot-assisted shoulder-elbow mobilization (consecutive where possible, for a maximum of 5 sessions per week) in addition to standard rehabilitation. During the first and last session, the patients' residual capabilities are assessed though robotic-aided assessments as well as with clinical scales. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic treatment - NESM alpha | Device | The NESM-α exoskeleton can deliver passive mobilization or active-assist support that follows the patient's voluntary motion. The joints' range of motion is adjusted in each session so that the treatment is tailored to the patient's recovery. The level of assistance is tuned during the first session to be tailored on patient residual capabilities. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | Safety of the delivered treatment is assessed monitoring the number of Adverse Events (AE). The metric is the number of events. | from enrollment to the end of treatment (up to 2 weeks) |
| Feasibility of recruitment and retention | Evaluate the number of patients that were recruited and retained for the full study period. Evaluate the number of drop-out. | Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's functionality | Patient's functionality is assessed with Fugl-Meyer Assessment. It ranges from 0-66 with 0 indicating no funcionality, and 66 normal motor function. | Days 1 and 7 |
| Patient's Spasticity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Federico Posteraro | ASL Nord Ovest Toscana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Versilia | Lido di Camaiore | Tuscany | 55041 | Italy |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Traditional feasibility study
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Patient's spasticity is assessed with the Modified Ashworth Scale (MAS). It rates spasticity (muscle tone) during passive stretch.
Range: 0, 1, 1+, 2, 3, 4. Direction: 0 = no increase in tone (best); 4 = rigid in flexion/extension (worst).
| Days 1 and 7 |
| Patient's Motor Function | Patient's motor function is assessed with the Wolf Motor Function Test (WMFT). It assesses upper-limb motor function via 15 timed tasks plus strength measures. Performance Time: seconds to complete each task (often capped at 120 s if not completed). Lower = better. | Days 1 and 7 |
| Patient's Pain | Patient's pain is assessed with the Numeric Pain Rating Scale (NPRS). Range: 0-10 (integer or 0.5 steps). Direction: 0 = no pain (best); 10 = worst imaginable pain (worst). | Days 1 and 7 |
| Joint Angles | Kinematic performance of the patient using the robot is assessed with the spanned joints angles (measured in degrees) | Days 1 and 7 |
| Joint Torques | Kinematic performance of the patient using the robot is assessed with the joint torques (measured in Nm) exchanged with the robot | Days 1 and 7 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |