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

NCT ID: NCT07316218

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-13
• Study Completion Date: 2025-03-14

Brief Summary

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

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.

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Robotic treatment - NESM alpha

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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°

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Scuola Superiore Sant'Anna di Pisa

OTHER

Sponsor Role: collaborator

Federico Posteraro

OTHER

Sponsor Role: lead

Responsible Party

Federico Posteraro

Head of Rehabilitation Department

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Federico Posteraro

Role: PRINCIPAL_INVESTIGATOR

ASL Nord Ovest Toscana

Locations

Ospedale Versilia

Lido di Camaiore, Tuscany, Italy

Countries

Italy

Other Identifiers

PAR FAS 2007-2013

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

RONDA201813581

Identifier Type: -

Identifier Source: org_study_id