Upper Limb DeficitsNCT07000279
Assessment of Feasibility, Functionality and Usability of an Hybrid Assistive Exoskeleton for Upper Limb
A study testing Assistive exoskeleton for activities of daily living (ADLs), Assistive exoskeleton for box and block and Assistive exoskeleton for maximum reaching height in people with Upper Limb Deficits, run by Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro at 1 site in Italy.
Trial summary
People affected by stroke or brachial plexus injuries experience huge impairment in using upper limbs for everyday life activities. Brachial plexus is responsible of sensory-motor innervation of the whole upper limb, the shoulder and also a part of the chest. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Limb Deficits
- What is being tested?
- Assistive exoskeleton for activities of daily living (ADLs), Assistive exoskeleton for box and block and Assistive exoskeleton for maximum reaching height
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 5 Sep 2025to Dec 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age between 18 and 65 years
- post-stroke or brachial plexus injuries patients
- upper limb motor deficit patients with Medical Research Council (MRC) Scale for Muscle Strength equal to or more than 2
- number of months after lesion higher than 6
- cognitive ability to follow instruction
- no Functional Electrical Stimulation (FES) treatment within 6 months prior to the enrollment
- absence of communication deficit
Who cannot join
- other nuerological or orthopaedic impairments
- pain in injuried upper limb (Numeric Rating Scale (NRS) higher than 4)
- cognitive impairments (Mini-Mental State Examination (MMSE) lower than 24)
- implantable devices that can interfere with FES
- muscle/neurological diseases that can get worse with FES
- fever or infection
Show all 9Show fewer
- pregnancy or breastfeeding
- absence of patient informed consent in written form
- unstable medical condition
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, 1 recruiting
- Recruiting
Centro Protesi Inail
Budrio, Bologna, 40054
Emanuele Gruppioni, Ph.D, +39 051 6936609, e.gruppioni@inail.it
Giovanni Hamoui, Orthopaedic Technician, g.hamoui@inail.it
About this study
Official title: Assessment of Feasibility, Functionality and Usability of an Hybrid Assistive Exoskeleton for Upper Limb: a Pilot Study
People affected by stroke or brachial plexus injuries experience huge impairment in using upper limbs for everyday life activities. Brachial plexus is responsible of sensory-motor innervation of the whole upper limb, the shoulder and also a part of the chest. The majority of such injuries is caused by traumatic events that involve young and healty people in most cases and motor impairment varies together with either the type (complete or incomplete) or the site of injury. It follows the need to realize devices capable of restoring people everyday life independence.
To assist these patients, the most common solutions are passive ortheses that give support to shoulder and forearm without actively enhancing limb functionalities. MyoPro (by MIT, Myomo1) is the only active device available for elbow and wrist, even not completely proven for everyday life yet. It comes from scientific evidences that gravity compensation and functional electrical stimulation (FES) are considerable techniques for rehabilitation of brachial plexus injuries and post-stroke patients. According to the most recent results, hybrid systems that combine FES with robotic joints seem to give interesting benefits in such the contexts taken into account.
Read more
The goal of this clinical trial is to assess feasibility, functionality and usability of a new assistive, hybrid, active and portable orthesis for upper limb aimed at improving motor functionality of brachial plexus injuries patients. Complying with weight and size requirements, the device under investigation is designed to assist the whole upper limb with its two modules: a robotic exoskeleton to actively give assistance to shoulder and elbow and a FES module to assist wrist and hand.
The main points the clinical trial aims to address concern:
- number and type of adverse events (device failures and malfunctioning, subjects injuries) during use
- evaluation of change in performance with and without the device
- usability and satisfaction after use
- effectiveness
Post-stroke and brachial plexus injuries patients (with Medical Research Council Scale for Muscle Strength equal to or more than 2) will be enrolled and asked to perform the following tasks with and without wearing the device:
- box and block test
- vertical reaching
- activities of daily living (ADLs) such as eating and drinking
Study procedure consists of 6 session outlined as follows:
- Session 1: enrollment
- Session 2: tuning and familiarization with device modules
- Session 3: tasks execution and outcomes measurement
- Session 4: tasks execution and outcomes measurement
- Session 5: tasks execution and outcomes measurement
- Session 6: extra session for any tasks from sessions 3,4,5 which required further investigations Each session will last 90 minutes at most. A preliminary phase will envolve healthy subjects that will be asked to perform the same tasks listed above. These tests will be useful to evaluate performances, functionalities and effectiveness of the modular solutions adopted, to improve the user experience of the device and to finalise the experimental procedure to follow with patients.
- Conditions
- Upper Limb Deficits
- Being tested
- Assistive exoskeleton for activities of daily living (ADLs), Assistive exoskeleton for box and block, Assistive exoskeleton for maximum reaching height
- Keywords
- assistive exoskeleton, upper arm, post stroke, brachial plexus injury, orthesis, functional electrical stimulation, activity of daily living, portable device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assistive exoskeleton for activities of daily living (ADLs)Device
Portable assistive exoskeleton to support upper limb movement during activities of daily living
Assistive exoskeleton for box and blockDevice
Portable assistive exoskeleton to support box and block test execution
Assistive exoskeleton for maximum reaching heightDevice
Portable assistive exoskeleton to raise the upper limb at the maximum of its capability to reach objects at different heights
| Study group | Role | What they receive |
|---|---|---|
| Recruited subjects with exoskeleton | Experimental | Subjects are asked to perform the study procedure while wearing the assistive device Receives: Device: Assistive exoskeleton for activities of daily living (ADLs); Device: Assistive exoskeleton for box and block; Device: Assistive exoskeleton for maximum reaching height |
| Recruited subjects without exoskeleton | No intervention | Subjects are asked to perform the study procedure not wearing the assistive device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events occurred during use of the exoskeleton
Number of device failures and malfunctioning, device-related harms during device use
Measured: During the intervention at days 2, 3, 4, 5
Change of score in Box and Blocks Test
The box and block test measures how many cubic wooden blocks the subject is able to move from one side of a wooden box to the other side in 60 seconds. The subject is asked to perform the Box And Blocks test while wearing the device and without the device for comparison.
Measured: During the intervention at days 3, 4, 5
Change in performance during the execution of activities of daily living (ADLs)
The subject is asked to perform different ADLs while wearing the device and without the device. Time for the execution and successful rate of activities are registered for comparison.
Measured: During the intervention at days 3, 4, 5
Change in kinematics during execution of tasks
The subject is asked to perform the box and block test, maximum reaching height task and activites of daily living while wearing the device in assitive mode and without the device. The experimental setup is provided with Magneto-Inertial Measurement Unit (M-IMU) sensors capable to measure speed and smoothness of movements in both cases for comparison.
Measured: During the intervention at days 3, 4, 5
Change in upper limbs muscles activation during execution of tasks
The subject is asked to perform the box and block test, maximum reaching height task and activites of daily living while wearing the device in assitive mode and without the device. The experimental setup is provided with surface EMG sensors capable to measure upper limb muscles activation in both cases for comparison.
Measured: During the intervention at days 3, 4, 5
Secondary outcomes (7)
System Usability Scale (SUS)
SUS is a questionnaire aiming at measuring the perceived usability of the device. It's a 10-item questionnaire, 5-points Likert scale with item score ranging from 1 (strongly disagree) to 5 (strongly agree). In SUS score calculation, each item's score contribution will range from 0 to 4 with the final score obtained by summing the score contributions from each item and multiplying it by 2.5, in order to have a value in the range of 0 to 100. The higer the final score, the better the outcome.
Measured: During the intervention at days 3, 4, 5
Quebec User Evaluation of Satisfaction with assistive Technology questionnaire (QUEST)
QUEST is a questionnaire aiming at measuring the perceived satisfaction of the device after use. It's a 12-item questionnaire, with item score ranging from 1 (worst) to 5 (best). The final score is obtained as an average of the items scores. The higer the final score, the better the outcome.
Measured: During the intervention at days 3, 4, 5
Numeric Rating Scale (NRS) for satisfaction
A custom NRS 0-10 is created to measure the perceived level of acceptance of the device after use. The subject is asked to evaluate its perception of weight, comfort, safety and assistance wearing the device, with item score ranging from 0 (best) to 10 (worst). The higher the scores, the worse the outcome.
Measured: During the intervention at days 3, 4, 5
Numeric Rating Scale (NRS) for pain evaluation
The subject is asked to evaluate its level of musculoskeletal pain after use with a score ranging from 0 (no pain) to 10 (max pain). The higher the score, the worse the outcome.
Measured: During the intervention at days 3, 4, 5
NASA Task Load Index (NASA-TLX)
NASA-TLX is used with the aim of measuring the effectiveness of the device after use. It is a multi-dimensional rating procedure that provides an overall workload score based on a weighted average of ratings on six subscales: Mental Demands, Physical Demands, Temporal Demands, Own Performance, Effort, and Frustration. For each task or group of tasks, the subject is asked to select an option for each of the 15 comparison cards given (to obtain weights) and to express a score ranging from 1 (low/good) to 20 (high/poor) for each subscale (rate). The final workload score is computed by multiplying each rating by the weight given to that factor by that subject, then the sum of the weighted ratings for each task is divided by 15. The higer the final score, the worse the outcome.
Measured: During the intervention at days 3, 4, 5
Flow State Scale (FSS)
FSS is a questionnaire aiming at measuring the user experience of the device during use. It's a 36-item questionnaire, with item score ranging from 1 (strongly disagree) to 5 (strongly agree). As 5-point Likert scale with 4 items per 9 subscales, the item scores for each dimension are summed and then divided by four, to obtain flow dimension item-average scores. The higer the final score, the better the outcome.
Measured: During the intervention at days 3, 4, 5
Category-Ratio 0-10 scale (Borg CR-10)
Borg CR-10 Scale is a subjective measure of perceived exertion or intensity during the execution of tasks. Body sensations under evaluation concern heart rate, breath rate and muscle fatigue with item score ranging from 0 (nothing at all) to 10 (maximum). The higher the single scores, the worse the outcome.
Measured: During the intervention at days 3, 4, 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2025
- Study start5 Sep 2025
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Upper Limb DeficitsStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
- Sponsor type
- University, hospital or other
- Collaborators
- Campus Bio-Medico University, Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
- Responsible party
- Principal investigator, Emanuele Gruppioni, Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000279
- Sponsor's protocol ID
- CP-PAI-03-23
- Status last verified
- Sep 2025
- First submitted
- 12 May 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Demographic and clinical data collected during the trial will be anonymized and aggregated prior to sharing
Publications
A. M. Stewart, C. G. Pretty, M. Adams, and X. Chen, "Review of Upper Limb Hybrid Exoskeletons," IFAC-Pap., vol. 50, no. 1, pp. 15169-15178, Jul. 2017, doi: 10.1016/j.ifacol.2017.08.2266.
M. F. Penna et al., "Design and Administration of a Questionnaire for the User-Centered Design of a Novel Upper-Limb Assistive Device for Brachial Plexus Injury and Post-stroke Subjects," in Computers Helping People with Special Needs, K. Miesenberger, G. Kouroupetroglou, K. Mavrou, R. Manduchi, M. Covarrubias Rodriguez, and P. Penáz, Eds., in Lecture Notes in Computer Science. Cham: Springer International Publishing, 2022, pp. 420-427. doi: 10.1007/978-3-031-08645-8_49.
Popovic MR, Thrasher TA, Zivanovic V, Takaki J, Hajek V. Neuroprosthesis for retraining reaching and grasping functions in severe hemiplegic patients. Neuromodulation. 2005 Jan;8(1):58-72. doi: 10.1111/j.1094-7159.2005.05221.x.
PubMed 22151384Resquin F, Cuesta Gomez A, Gonzalez-Vargas J, Brunetti F, Torricelli D, Molina Rueda F, Cano de la Cuerda R, Miangolarra JC, Pons JL. Hybrid robotic systems for upper limb rehabilitation after stroke: A review. Med Eng Phys. 2016 Nov;38(11):1279-1288. doi: 10.1016/j.medengphy.2016.09.001. Epub 2016 Sep 29.
PubMed 27692878Ferrante MA. Brachial plexopathies: classification, causes, and consequences. Muscle Nerve. 2004 Nov;30(5):547-68. doi: 10.1002/mus.20131.
PubMed 15452843
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Feasibility, Functionality and Usability of an Hybrid Assistive Exoskeleton for Upper Limb: a Pilot Study
- ClinicalTrials.gov ID
- NCT07000279
- Acronym / sponsor ID
- CP-PAI-03-23
- Conditions
- Upper Limb Deficits
- Keywords
- assistive exoskeleton, upper arm, post stroke, brachial plexus injury, orthesis, functional electrical stimulation, activity of daily living, portable device
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Istituto Nazionale Assicurazione contro gli Infortuni sul LavoroUniversity, hospital or other
- Collaborators
- Campus Bio-Medico University, Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 2 Jun 2025 (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.
People affected by stroke or brachial plexus injuries experience huge impairment in using upper limbs for everyday life activities. Brachial plexus is responsible of sensory-motor innervation of the whole upper limb, the shoulder and also a part of the chest. The majority of such injuries is caused by traumatic events that involve young and healty people in most cases and motor impairment varies together with either the type (complete or incomplete) or the site of injury. It follows the need to realize devices capable of restoring people everyday life independence.
To assist these patients, the most common solutions are passive ortheses that give support to shoulder and forearm without actively enhancing limb functionalities. MyoPro (by MIT, Myomo1) is the only active device available for elbow and wrist, even not completely proven for everyday life yet. It comes from scientific evidences that gravity compensation and functional electrical stimulation (FES) are considerable techniques for rehabilitation of brachial plexus injuries and post-stroke patients. According to the most recent results, hybrid systems that combine FES with robotic joints seem to give interesting benefits in such the contexts taken into account.
The goal of this clinical trial is to assess feasibility, functionality and usability of a new assistive, hybrid, active and portable orthesis for upper limb aimed at improving motor functionality of brachial plexus injuries patients. Complying with weight and size requirements, the device under investigation is designed to assist the whole upper limb with its two modules: a robotic exoskeleton to actively give assistance to shoulder and elbow and a FES module to assist wrist and hand.
The main points the clinical trial aims to address concern:
- number and type of adverse events (device failures and malfunctioning, subjects injuries) during use
- evaluation of change in performance with and without the device
- usability and satisfaction after use
- effectiveness
Post-stroke and brachial plexus injuries patients (with Medical Research Council Scale for Muscle Strength equal to or more than 2) will be enrolled and asked to perform the following tasks with and without wearing the device:
- box and block test
- vertical reaching
- activities of daily living (ADLs) such as eating and drinking
Study procedure consists of 6 session outlined as follows:
- Session 1: enrollment
- Session 2: tuning and familiarization with device modules
- Session 3: tasks execution and outcomes measurement
- Session 4: tasks execution and outcomes measurement
- Session 5: tasks execution and outcomes measurement
- Session 6: extra session for any tasks from sessions 3,4,5 which required further investigations Each session will last 90 minutes at most. A preliminary phase will envolve healthy subjects that will be asked to perform the same tasks listed above. These tests will be useful to evaluate performances, functionalities and effectiveness of the modular solutions adopted, to improve the user experience of the device and to finalise the experimental procedure to follow with patients.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recruited subjects with exoskeleton | Experimental | Device: Assistive exoskeleton for activities of daily living (ADLs), Device: Assistive exoskeleton for box and block, Device: Assistive exoskeleton for maximum reaching heightSubjects are asked to perform the study procedure while wearing the assistive device |
| Recruited subjects without exoskeleton | No intervention | –Subjects are asked to perform the study procedure not wearing the assistive device |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age between 18 and 65 years
- post-stroke or brachial plexus injuries patients
- upper limb motor deficit patients with Medical Research Council (MRC) Scale for Muscle Strength equal to or more than 2
- number of months after lesion higher than 6
- cognitive ability to follow instruction
Key exclusion criteria (9 listed)
- other nuerological or orthopaedic impairments
- pain in injuried upper limb (Numeric Rating Scale (NRS) higher than 4)
- cognitive impairments (Mini-Mental State Examination (MMSE) lower than 24)
- implantable devices that can interfere with FES
- muscle/neurological diseases that can get worse with FES
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 |
|---|---|---|
| Assistive exoskeleton for activities of daily living (ADLs)Portable assistive exoskeleton to support upper limb movement during activities of daily living | Device | Recruited subjects with exoskeleton |
| Assistive exoskeleton for box and blockPortable assistive exoskeleton to support box and block test execution | Device | Recruited subjects with exoskeleton |
| Assistive exoskeleton for maximum reaching heightPortable assistive exoskeleton to raise the upper limb at the maximum of its capability to reach objects at different heights | Device | Recruited subjects with exoskeleton |
Primary outcome
Number of adverse events occurred during use of the exoskeleton
Time frame: During the intervention at days 2, 3, 4, 5
Number of device failures and malfunctioning, device-related harms during device use
Change of score in Box and Blocks Test
Time frame: During the intervention at days 3, 4, 5
The box and block test measures how many cubic wooden blocks the subject is able to move from one side of a wooden box to the other side in 60 seconds. The subject is asked to perform the Box And Blocks test while wearing the device and without the device for comparison.
Change in performance during the execution of activities of daily living (ADLs)
Time frame: During the intervention at days 3, 4, 5
The subject is asked to perform different ADLs while wearing the device and without the device. Time for the execution and successful rate of activities are registered for comparison.
Change in kinematics during execution of tasks
Time frame: During the intervention at days 3, 4, 5
The subject is asked to perform the box and block test, maximum reaching height task and activites of daily living while wearing the device in assitive mode and without the device. The experimental setup is provided with Magneto-Inertial Measurement Unit (M-IMU) sensors capable to measure speed and smoothness of movements in both cases for comparison.
Change in upper limbs muscles activation during execution of tasks
Time frame: During the intervention at days 3, 4, 5
The subject is asked to perform the box and block test, maximum reaching height task and activites of daily living while wearing the device in assitive mode and without the device. The experimental setup is provided with surface EMG sensors capable to measure upper limb muscles activation in both cases for comparison.
7 secondary outcomes
System Usability Scale (SUS)
Time frame: During the intervention at days 3, 4, 5
Quebec User Evaluation of Satisfaction with assistive Technology questionnaire (QUEST)
Time frame: During the intervention at days 3, 4, 5
Numeric Rating Scale (NRS) for satisfaction
Time frame: During the intervention at days 3, 4, 5
Numeric Rating Scale (NRS) for pain evaluation
Time frame: During the intervention at days 3, 4, 5
NASA Task Load Index (NASA-TLX)
Time frame: During the intervention at days 3, 4, 5
Flow State Scale (FSS)
Time frame: During the intervention at days 3, 4, 5
Category-Ratio 0-10 scale (Borg CR-10)
Time frame: During the intervention at days 3, 4, 5
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 29 Sep 2025.
- BackgroundA. M. Stewart, C. G. Pretty, M. Adams, and X. Chen, "Review of Upper Limb Hybrid Exoskeletons," IFAC-Pap., vol. 50, no. 1, pp. 15169-15178, Jul. 2017, doi: 10.1016/j.ifacol.2017.08.2266.
- BackgroundM. F. Penna et al., "Design and Administration of a Questionnaire for the User-Centered Design of a Novel Upper-Limb Assistive Device for Brachial Plexus Injury and Post-stroke Subjects," in Computers Helping People with Special Needs, K. Miesenberger, G. Kouroupetroglou, K. Mavrou, R. Manduchi, M. Covarrubias Rodriguez, and P. Penáz, Eds., in Lecture Notes in Computer Science. Cham: Springer International Publishing, 2022, pp. 420-427. doi: 10.1007/978-3-031-08645-8_49.
- Background: PubMed 22151384Popovic MR, Thrasher TA, Zivanovic V, Takaki J, Hajek V. Neuroprosthesis for retraining reaching and grasping functions in severe hemiplegic patients. Neuromodulation. 2005 Jan;8(1):58-72. doi: 10.1111/j.1094-7159.2005.05221.x.
- Background: PubMed 27692878Resquin F, Cuesta Gomez A, Gonzalez-Vargas J, Brunetti F, Torricelli D, Molina Rueda F, Cano de la Cuerda R, Miangolarra JC, Pons JL. Hybrid robotic systems for upper limb rehabilitation after stroke: A review. Med Eng Phys. 2016 Nov;38(11):1279-1288. doi: 10.1016/j.medengphy.2016.09.001. Epub 2016 Sep 29.
- Background: PubMed 15452843Ferrante MA. Brachial plexopathies: classification, causes, and consequences. Muscle Nerve. 2004 Nov;30(5):547-68. doi: 10.1002/mus.20131.
- Individual participant dataSharing planned: Yes. Demographic and clinical data collected during the trial will be anonymized and aggregated prior to sharing
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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 Assistive exoskeleton for activities of daily living (ADLs), Assistive exoskeleton for box and block and Assistive exoskeleton for maximum reaching height in people with Upper Limb Deficits, run by Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro 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 7 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 29 Sep 2025. 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 Emanuele Gruppioni, PhD (+39 051 6936 609, e.gruppioni@inail.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events occurred during use of the exoskeleton (time frame: During the intervention at days 2, 3, 4, 5). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07000279, which also lists 5 linked publications.
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 29 Sep 2025.