An interventional study of FRONTIER Soft Exoskeleton in Acquired Brain Injury, sponsored by Università Vita-Salute San Raffaele. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Università Vita-Salute San Raffaele · Not applicable, Interventional, and Device feasibility
Development of a soft robotic device for rehabilitation and assistance of the upper limb for people with neurological disorders (FRONTIER)
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.
946 studies on the registry are indexed under Brain Injuries; 235 are open to participants now.
This study's planned enrollment of 20 is below the median of 41 across 612 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →Università Vita-Salute San Raffaele is the lead sponsor of 85 studies on the registry; 33 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Healthy volunteers:
Patients:
Exclusion Criteria:
Healthy volunteers:
Patients:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: Day 1. Immediately after completion of the single testing session
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.
Time frame: 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.
Time frame: 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.
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
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.
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
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.
Time frame: Day 1. From device fitting through completion of the single testing session
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Università Vita-Salute San Raffaele