Assessment of Feasibility, Functionality and Usability of an Hybrid Assistive Exoskeleton for Upper Limb

Not Applicable

Not yet recruiting

• Conditions: Upper Limb Deficits

• Registration Number: NCT07000279
• Lead Sponsor: Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-12
• Study First Submitted QC: 2025-05-29
• Last Update Submitted: 2025-05-29
• Study Start: 2025-06
• Study First Posted: 2025-06-02
• Last Update Posted: 2025-06-02
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Number of adverse events occurred during use of the exoskeleton	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	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)	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	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	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.

Secondary Outcome Measures

Name	Time	Method
System Usability Scale (SUS)	During the intervention at days 3, 4, 5	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.
Quebec User Evaluation of Satisfaction with assistive Technology questionnaire (QUEST)	During the intervention at days 3, 4, 5	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.
Numeric Rating Scale (NRS) for satisfaction	During the intervention at days 3, 4, 5	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.
Numeric Rating Scale (NRS) for pain evaluation	During the intervention at days 3, 4, 5	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.
NASA Task Load Index (NASA-TLX)	During the intervention at days 3, 4, 5	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.
Flow State Scale (FSS)	During the intervention at days 3, 4, 5	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.
Category-Ratio 0-10 scale (Borg CR-10)	During the intervention at days 3, 4, 5	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.