Clinical trial NCT07000279: Assessment of Feasibility, Functionality and Usability of an Hybrid Assistive Exoskeleton for Upper Limb
Official title: Assessment of Feasibility, Functionality and Usability of an Hybrid Assistive Exoskeleton for Upper Limb: a Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Upper Limb Deficits
Keywords: assistive exoskeleton
upper arm
post stroke
brachial plexus injury
orthesis
functional electrical stimulation
activity of daily living
portable device
Lead sponsor: Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
Sponsor class: OTHER
Collaborators: name: Università Campus Bio-Medico di Roma (UCBM)
name: Scuola Superiore Sant'Anna di Pisa
First posted: 2025-06-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DEVICE_FEASIBILITY

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* pregnancy or breastfeeding
* absence of patient informed consent in written form
* unstable medical condition

Primary outcomes:
measure: Number of adverse events occurred during use of the exoskeleton
timeFrame: During the intervention at days 2, 3, 4, 5
measure: Change of score in Box and Blocks Test
timeFrame: During the intervention at days 3, 4, 5
measure: Change in performance during the execution of activities of daily living (ADLs)
timeFrame: During the intervention at days 3, 4, 5
measure: Change in kinematics during execution of tasks
timeFrame: During the intervention at days 3, 4, 5
measure: Change in upper limbs muscles activation during execution of tasks
timeFrame: During the intervention at days 3, 4, 5
Secondary outcomes:
measure: System Usability Scale (SUS)
timeFrame: During the intervention at days 3, 4, 5
measure: Quebec User Evaluation of Satisfaction with assistive Technology questionnaire (QUEST)
timeFrame: During the intervention at days 3, 4, 5
measure: Numeric Rating Scale (NRS) for satisfaction
timeFrame: During the intervention at days 3, 4, 5
measure: Numeric Rating Scale (NRS) for pain evaluation
timeFrame: During the intervention at days 3, 4, 5
measure: NASA Task Load Index (NASA-TLX)
timeFrame: During the intervention at days 3, 4, 5
measure: Flow State Scale (FSS)
timeFrame: During the intervention at days 3, 4, 5
measure: Category-Ratio 0-10 scale (Borg CR-10)
timeFrame: During the intervention at days 3, 4, 5
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: Resquin 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.
citation: Ferrante MA. Brachial plexopathies: classification, causes, and consequences. Muscle Nerve. 2004 Nov;30(5):547-68. doi: 10.1002/mus.20131.