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

Official title

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

Overview

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

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.

Interventions

• Device FRONTIER Soft Exoskeleton
  Each participant (both healthy volunteers and patients) will take part in one single testing session, structured as follows: 1. Unassisted condition: subjects will perform a set of standardized upper limb movements (shoulder, elbow, and hand) without robotic assistance. 2. Assisted condition (robot active): the same set of movements will be repeated with the support of the FRONTIER exoskeleton.

Primary outcome measures

• Usability of the FRONTIER Soft Exoskeleton as Assessed by the System Usability Scale (SUS) Total Score [Time frame: Day 1. Immediately after completion of the single testing session]

Secondary outcome measures (5)

• Difference in Mean Normalized Surface Electromyography (sEMG) Amplitude Between Robotic-Assisted and Unassisted Movements [Time frame: Day 1. During the single testing session]
• Mean Difference in Upper-Limb Range of Motion Between Robotic-Assisted and Unassisted Movements [Time frame: Day 1. During the single testing session]
• NASA Task Load Index (NASA-TLX) Overall Workload Score After Robotic-Assisted Testing [Time frame: 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 [Time frame: 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 [Time frame: Day 1. From device fitting through completion of the single testing session]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Device feasibility

Study locations

Italy · 1 center

• IRCCS Ospedale San Raffaele — Milan

Identifiers

NCT: NCT07750314 · CET 86-2026

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗