Personalized Wearable Robotics for Upper-limb Motor Rehabilitation in Neurological Patients. A Pilot Study.

Personalized Wearable Robotics for Upper-limb Motor Rehabilitation in Neurological Patients. A Pilot Study.

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.

Inclusion Criteria:

• Unilateral ischemic or hemorrhagic stroke, sub-acute (<6 months) or chronic (>6 months)
• Severe spasticity (MAS ≥ 2) or mild-moderate spasticity with residual active antigravity movements (MAS < 2)
• Fugl-Meyer upper extremity score ≤ 42
• MMSE > 24
• No severe pain during passive mobilization
• Written informed consent

Exclusion Criteria:

• Unstable clinical conditions
• Inability to maintain sitting posture
• Pacemaker or other implanted electronic devices
• Passive range of motion < 10°