Development of a Soft Robotic Device for Rehabilitation and Assistance of the Upper Limb for People With Neurological Disorders (FRONTIER)

FRONTIER - Development of a Soft Robotic Device for Rehabilitation and Assistance of the Upper Limb for People With Neurological Disorders.

Development of a soft robotic device for rehabilitation and assistance of the upper limb for people with neurological disorders (FRONTIER)

Study Overview

• Status: Not yet recruiting
• Conditions: Acquired Brain Injury
• Intervention / Treatment: Device: FRONTIER Soft Exoskeleton

Detailed Description

Wearable robotics is a rapidly expanding field, with robotic devices increasingly being explored and integrated into neurorehabilitation practice. Robotic exoskeletons based on motor learning principles have been introduced to support rehabilitation interventions and are available in a wide range of configurations, including soft or rigid architectures, systems with single or multiple degrees of freedom, and devices targeting either the upper or lower limbs.

In this context, FRONTIER aims to develop, integrate, and evaluate a soft robotic exoskeleton designed to support upper-limb motor function in individuals with chronic neurological impairments resulting from acquired brain injury (ABI). The device is intended to assist both isolated and coordinated multi-joint movements involving proximal upper-limb segments, including the shoulder and elbow, and distal segments, including the hand.

The primary objective of FRONTIER is to evaluate the clinical usability of the soft robotic exoskeleton prototype, which integrates existing robotic modules, and to support the development of synergistic control algorithms coordinating assistance across multiple upper-limb joints. The study will evaluate the usability, safety, and acceptability of the system during a single testing session in a clinical rehabilitation setting. The findings will provide preliminary information to guide further development and future evaluation of the device in neurorehabilitation.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pietro Mortini, Prof. MD; Phone Number: +39 0226435568; Email: sincinelli.laura@hsr.it

Study Locations

• Italy
  • Milan
    • Milan, Milan, Italy, 20132
      • IRCCS Ospedale San Raffaele
      • Contact: Laura Sincinelli; Phone Number: +39 0226435568; Email: sincinelli.laura@hsr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Healthy volunteers:

• Male and female participants
• Age ≥ 18 and ≤ 80 years
• Absence of neurological, neuromuscular, or orthopedic conditions that may affect upper-limb use
• Willingness to comply with study procedures and to sign the informed consent form
• Ability to understand and sign the informed consent form

Patients:

• Male and female participants
• Age ≥ 18 and ≤ 80 years
• Clinical diagnosis of acquired brain injury (ABI), in the chronic phase (≥ 6 months after the event)
• Persistent upper-limb motor impairment
• Medically stable condition and ability to sit upright or stand for the duration of the testing session
• Willingness to participate in the study intervention
• Ability to understand and sign the informed consent form
• Preserved cognitive function, assessed by the Mini-Mental State Examination (MMSE ≥ 24/30)

Exclusion Criteria:

Healthy volunteers:

• Age < 18 or > 80 years
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study period

Patients:

• Age < 18 or > 80 years
• Cognitive impairment interfering with the understanding of the tasks or study protocol, assessed by the Mini-Mental State Examination (MMSE < 24/30)
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study period

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: FRONTIER Soft Exoskeleton Testing

Device: FRONTIER Soft Exoskeleton; Each participant (both healthy volunteers and patients) will take part in one single testing session, structured as follows: Unassisted condition: subjects will perform a set of standardized upper limb movements (shoulder, elbow, and hand) without robotic assistance.; Assisted condition (robot active): the same set of movements will be repeated with the support of the FRONTIER exoskeleton.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability of the FRONTIER Soft Exoskeleton as Assessed by the System Usability Scale (SUS) Total Score	Device usability will be measured using the 10-item System Usability Scale (SUS) following use of the FRONTIER soft exoskeleton prototype. Each item is rated on a 5-point Likert scale, and item scores are converted and combined to obtain a total score ranging from 0 to 100 points. Higher scores indicate greater perceived usability of the prototype. Device usability represents the primary feasibility-related outcome of the study and does not assess changes in participants' health status. SUS total scores will be reported separately for healthy volunteers and participants with chronic acquired brain injury.	Day 1. Immediately after completion of the single testing session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Mean Normalized Surface Electromyography (sEMG) Amplitude Between Robotic-Assisted and Unassisted Movements	Muscle activity during upper-limb movements will be recorded using surface electromyography (sEMG) under two conditions: with and without assistance from the FRONTIER soft exoskeleton. sEMG amplitude will be quantified using the root mean square (RMS) and normalized to the maximum voluntary contraction, expressed as a percentage of maximum voluntary contraction (%MVC). For each participant, the mean normalized RMS amplitude across the predefined muscles and movement repetitions will be calculated for each condition. The reported outcome will be the within-participant difference between the robotic-assisted and unassisted conditions.	Day 1. During the single testing session
Mean Difference in Upper-Limb Range of Motion Between Robotic-Assisted and Unassisted Movements	Upper-limb range of motion will be measured during shoulder, elbow, and forearm movements performed with and without assistance from the FRONTIER soft exoskeleton. For each movement, range of motion will be calculated as the difference between the maximum and minimum joint angles recorded using inertial sensors. For each participant, the differences in range of motion between the robotic-assisted and unassisted conditions will be averaged across all predefined movements to obtain a single mean difference. Positive values indicate a greater overall range of motion with robotic assistance.	Day 1. During the single testing session
NASA Task Load Index (NASA-TLX) Overall Workload Score After Robotic-Assisted Testing	Perceived workload associated with use of the FRONTIER soft exoskeleton will be measured using the NASA Task Load Index (NASA-TLX). The questionnaire assesses six dimensions: mental demand, physical demand, temporal demand, performance, effort, and frustration. Each dimension is rated on a scale from 0 to 100 points. The overall workload score will be calculated as the mean of the six dimension scores and will range from 0 to 100 points. Higher scores indicate greater perceived workload.	Day 1. Immediately after completion of the robotic-assisted testing session
Mean Difference in Borg Category-Ratio 10 Fatigue Score Between Robotic-Assisted and Unassisted Movements	Perceived fatigue will be measured using the Borg Category-Ratio 10 scale (Borg CR10) immediately after each predefined shoulder, elbow, and forearm movement performed with and without assistance from the FRONTIER soft exoskeleton. Scores range from 0, indicating no fatigue, to 10, indicating maximal fatigue. For each participant, Borg CR10 scores will be averaged across the predefined movements for each condition. The reported outcome will be the within-participant difference between the robotic-assisted and unassisted conditions. Positive values indicate greater perceived fatigue with robotic assistance, whereas negative values indicate lower perceived fatigue with robotic assistance.	Day 1. Immediately after each predefined movement performed with and without robotic assistance during the single testing session
Device-Related Adverse Events During the Single Testing Session	Safety of the FRONTIER soft exoskeleton will be assessed by recording any device-related adverse events occurring during the testing session. Adverse events may include pain, skin irritation, pressure-related symptoms, or any other undesirable medical occurrence considered related to use of the device.	Day 1. From device fitting through completion of the single testing session

Collaborators and Investigators

• Sponsor: Università Vita-Salute San Raffaele
• Collaborators: IRCCS San Raffaele

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 14, 2026
• First Submitted That Met QC Criteria: August 1, 2026
• First Posted (Actual): August 6, 2026

Study Record Updates

• Last Update Posted (Actual): August 6, 2026
• Last Update Submitted That Met QC Criteria: August 1, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries
• Other Study ID Numbers: CET 86-2026

Drug and device information, study documents

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