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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-05

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Upper Limb Deficits

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Recruited subjects with exoskeleton

Subjects are asked to perform the study procedure while wearing the assistive device

Group Type EXPERIMENTAL

Assistive exoskeleton for activities of daily living (ADLs)

Intervention Type DEVICE

Portable assistive exoskeleton to support upper limb movement during activities of daily living

Assistive exoskeleton for box and block

Intervention Type DEVICE

Portable assistive exoskeleton to support box and block test execution

Assistive exoskeleton for maximum reaching height

Intervention Type DEVICE

Portable assistive exoskeleton to raise the upper limb at the maximum of its capability to reach objects at different heights

Recruited subjects without exoskeleton

Subjects are asked to perform the study procedure not wearing the assistive device

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Assistive exoskeleton for activities of daily living (ADLs)

Portable assistive exoskeleton to support upper limb movement during activities of daily living

Intervention Type DEVICE

Assistive exoskeleton for box and block

Portable assistive exoskeleton to support box and block test execution

Intervention Type DEVICE

Assistive exoskeleton for maximum reaching height

Portable assistive exoskeleton to raise the upper limb at the maximum of its capability to reach objects at different heights

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes