An interventional study of Robotic treatment - NESM alpha in Stroke, sponsored by Federico Posteraro. Completed at 1 site in Italy. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-01-05.
Sponsored by Federico Posteraro · Not applicable, Interventional, and Device feasibility
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 7 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →This is the only study on the registry with Federico Posteraro as lead sponsor.
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Exclusion Criteria:
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.
Device: Robotic treatment - NESM alpha
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.
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.
Time frame: 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.
Time frame: Day 7
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.
Time frame: Days 1 and 7
Patient's Spasticity
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).
Time frame: 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.
Time frame: 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).
Time frame: Days 1 and 7
Joint Angles
Kinematic performance of the patient using the robot is assessed with the spanned joints angles (measured in degrees)
Time frame: 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
Time frame: Days 1 and 7
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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