Acquired Brain InjuryFRONTIERNCT07750314
Development of a Soft Robotic Device for Rehabilitation and Assistance of the Upper Limb for People With Neurological Disorders
A study testing FRONTIER Soft Exoskeleton in people with Acquired Brain Injury, run by Università Vita-Salute San Raffaele at 1 site in Italy.
Trial summary
Development of a soft robotic device for rehabilitation and assistance of the upper limb for people with neurological disorders (FRONTIER) Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Acquired Brain Injury
- What is being tested?
- FRONTIER Soft Exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
IRCCS Ospedale San Raffaele
Milan, Milan, 20132
Laura Sincinelli, 0226435568 ext. +39, sincinelli.laura@hsr.it
About this study
Official title: 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)
Read the 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.
- Conditions
- Acquired Brain Injury
- Being tested
- FRONTIER Soft Exoskeleton
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FRONTIER Soft ExoskeletonDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| FRONTIER Soft Exoskeleton Testing | Experimental | Not described Receives: Device: FRONTIER Soft Exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1. From device fitting through completion of the single testing session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università Vita-Salute San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS San Raffaele
- Responsible party
- Principal investigator, PIETRO MORTINI, Università Vita-Salute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07750314
- Sponsor's protocol ID
- CET 86-2026
- Acronym
- FRONTIER
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FRONTIER - Development of a Soft Robotic Device for Rehabilitation and Assistance of the Upper Limb for People With Neurological Disorders.
- ClinicalTrials.gov ID
- NCT07750314
- Acronym / sponsor ID
- FRONTIER / CET 86-2026
- Conditions
- Acquired Brain Injury
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Collaborators
- IRCCS San Raffaele
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FRONTIER Soft Exoskeleton Testing | Experimental | Device: FRONTIER Soft Exoskeleton |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (7 listed)
- Age < 18 or > 80 years
- Women who are pregnant, breastfeeding, or planning to become pregnant during the study period
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FRONTIER Soft ExoskeletonEach 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. | Device | FRONTIER Soft Exoskeleton Testing |
Primary outcome
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
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FRONTIER Soft Exoskeleton in people with Acquired Brain Injury, run by Università Vita-Salute San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pietro Mortini, Prof. MD (0226435568 ext. +39, sincinelli.laura@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.