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

NCT07000279 | Recruiting DMC

• 1 other identifier: CP-PAI-03-23
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Limb Deficits

Keywords

assistive exoskeleton; upper arm; post stroke; brachial plexus injury; orthesis; functional electrical stimulation; activity of daily living; portable device

Outcome Measures

Primary Outcomes (5)

• Number of adverse events occurred during use of the exoskeleton

  Number of device failures and malfunctioning, device-related harms during device use

  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.

  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.

  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.

  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.

  During the intervention at days 3, 4, 5

Secondary Outcomes (7)

• System Usability Scale (SUS)

  During the intervention at days 3, 4, 5

• Quebec User Evaluation of Satisfaction with assistive Technology questionnaire (QUEST)

  During the intervention at days 3, 4, 5

• Numeric Rating Scale (NRS) for satisfaction

  During the intervention at days 3, 4, 5

• Numeric Rating Scale (NRS) for pain evaluation

  During the intervention at days 3, 4, 5

• NASA Task Load Index (NASA-TLX)

  During the intervention at days 3, 4, 5

Study Arms (2)

Recruited subjects with exoskeleton

EXPERIMENTAL

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

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

Interventions

Assistive exoskeleton for activities of daily living (ADLs) DEVICE

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

Recruited subjects with exoskeleton

Assistive exoskeleton for box and block DEVICE

Portable assistive exoskeleton to support box and block test execution

Recruited subjects with exoskeleton

Assistive exoskeleton for maximum reaching height DEVICE

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

Recruited subjects with exoskeleton

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro: lead
• Università Campus Bio-Medico di Roma (UCBM): collaborator
• Scuola Superiore Sant'Anna di Pisa: collaborator

Study Sites (1)

Centro Protesi Inail

Budrio, Bologna, 40054, Italy

RECRUITING

Related Publications (5)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 22151384 BACKGROUND

• 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.

  PMID: 27692878 BACKGROUND

• Ferrante MA. Brachial plexopathies: classification, causes, and consequences. Muscle Nerve. 2004 Nov;30(5):547-68. doi: 10.1002/mus.20131.

  PMID: 15452843 BACKGROUND

MeSH Terms

Interventions

Activities of Daily Living; Dental Occlusion

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Central Study Contacts

Emanuele Gruppioni, PhD

CONTACT

+39 051 6936 609; e.gruppioni@inail.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Engineer, Orthopaedic Technician

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: June 2, 2025
• Study Start: September 5, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Within one year after trial conclusion (december 2025)
• Access Criteria: Anonymized not aggregated data could be available upon request

Locations

IT (1)