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

The study is designed as an open-label pilot study with a pre-post treatment assessment.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Robotic treatment - NESM alpha

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Tuscany
    • Lido di Camaiore, Tuscany, Italy, 55041
      • Ospedale Versilia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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°

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: NESM-alpha; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Federico Posteraro
• Collaborators: Scuola Superiore Sant'Anna di Pisa
• Investigators: Principal Investigator: Federico Posteraro, ASL Nord Ovest Toscana

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2024
• Primary Completion (Actual): March 14, 2025
• Study Completion (Actual): March 14, 2025

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): January 5, 2026

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Stroke; Exoskeleton; Pilot Study
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: RONDA201813581; PAR FAS 2007-2013 (Other Grant/Funding Number: MIUR - MISE - REGIONE TOSCANA DGRT 758/2013)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No