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

NCT07750314 | Not Yet Recruiting

• 1 other identifier: CET 86-2026
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acquired Brain Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Difference in Mean Normalized Surface Electromyography (sEMG) Amplitude Between Robotic-Assisted and Unassisted Movements

  Day 1. During the single testing session

• Mean Difference in Upper-Limb Range of Motion Between Robotic-Assisted and Unassisted Movements

  Day 1. During the single testing session

• NASA Task Load Index (NASA-TLX) Overall Workload Score After Robotic-Assisted Testing

  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

  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

  Day 1. From device fitting through completion of the single testing session

Study Arms (1)

FRONTIER Soft Exoskeleton Testing

EXPERIMENTAL

Device: FRONTIER Soft Exoskeleton

Interventions

FRONTIER Soft Exoskeleton DEVICE

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.

FRONTIER Soft Exoskeleton Testing

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Università Vita-Salute San Raffaele: lead
• IRCCS San Raffaele: collaborator

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, Milan, 20132, Italy

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Pietro Mortini, Prof. MD

CONTACT

0226435568; sincinelli.laura@hsr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor, M.D., Director, Post-graduate School of Neurosurgery Università Vita-Salute S. Raffaele

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: August 6, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 6, 2026

Record last verified: 2026-07

Locations

IT (1)