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

NCT07316218 | Completed

• 2 other identifiers: RONDA201813581PAR FAS 2007-2013
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stroke

Keywords

Stroke; Pilot Study; Exoskeleton

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Patient's functionality

  Days 1 and 7

• Patient's Spasticity

  Days 1 and 7

• Patient's Motor Function

  Days 1 and 7

• Patient's Pain

  Days 1 and 7

• Joint Angles

  Days 1 and 7

Study Arms (1)

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.

Device: Robotic treatment - NESM alpha

Interventions

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.

NESM-alpha

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Federico Posteraro: lead
• Scuola Superiore Sant'Anna di Pisa: collaborator

Study Sites (1)

Ospedale Versilia

Lido di Camaiore, Tuscany, 55041, Italy

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Federico Posteraro

  ASL Nord Ovest Toscana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Rehabilitation Department

Model Details: Traditional feasibility study

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: January 5, 2026
• Study Start: November 13, 2024
• Primary Completion: March 14, 2025
• Study Completion: March 14, 2025
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)