Passive Exoskeletons for Assisting Patients With Shoulder Musculoskeletal Disorders

NCT ID: NCT06842017

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-28
• Study Completion Date: 2029-06-30

Brief Summary

Goal: The clinical investigation aims to evaluate the usability of passive exoskeletons, their impact on daily living activities, and the perceived experience of patients with shoulder musculoskeletal disorders. This will be assessed through specific validated questionnaires.

Participant Population: The study will enroll 15 participants diagnosed with shoulder musculoskeletal disorders, including rotator cuff tears, adhesive capsulitis, and glenohumeral osteoarthritis. Participants must be employed in physically demanding jobs that require frequent upper limb activity.

Main Questions:

• How does the integration of passive exoskeletons in daily activities influence usability and functional performance in patients with shoulder musculoskeletal disorders?
• To what extent does the use of passive exoskeletons improve the perceived physical effort and quality of life in these patients?
• How do patients perceive the comfort and effectiveness of passive exoskeletons during the execution of daily living tasks?

Participant Tasks:

• Comprehensive shoulder physical examination. Instruction on the proper use of the Paexo passive exoskeleton and customization of its settings.
• Execution of workplace-relevant tasks (e.g., lifting, overhead reaching) with and without the exoskeleton.
• Evaluation of usability, comfort, and perceived workload using validated scales such as the System Usability Scale (SUS), NASA Task Load Index (NASA-TLX), and Technology Acceptance Model (TAM).

Detailed Description

Shoulder musculoskeletal disorders, such as rotator cuff injuries, adhesive capsulitis, and osteoarthritis, severely impact daily activities due to pain, reduced mobility, and muscle weakness. These conditions limit tasks like lifting, reaching, and even simple activities such as dressing or combing hair, significantly affecting patients' quality of life. While traditional physiotherapy can help, barriers such as limited access and poor adherence to home exercises hinder its effectiveness. This has led to the exploration of new rehabilitation methods, particularly passive exoskeletons.

Passive exoskeletons, which use mechanical components like springs to assist movement without external power, have shown potential in reducing muscle strain and supporting tasks requiring arm elevation or lifting. These devices are lightweight, cost-effective, and easy to use, but research on their application for patients with musculoskeletal disorders is limited.

This study aims to assess the impact of passive exoskeletons on joint functionality, pain reduction, and performance of activities of daily living (ADLs) in patients with shoulder disorders. It will also evaluate the usability and comfort of the devices using validated questionnaires. Participants will be enrolled from the FPUCBM Unit of Traumatology and Sports Medicine and undergo experimental sessions involving movement tasks with and without the exoskeleton. The study will measure biomechanical effects, pain levels, and user satisfaction, with the ultimate goal of integrating passive exoskeletons into clinical rehabilitation protocols to improve patient outcomes.

Conditions

Shoulder Musculoskeletal Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients with shoulder musculoskeletal disorders

The study will involve 15 adults with shoulder musculoskeletal disorders. Eligible participants must be over 18 years old and diagnosed with conditions such as rotator cuff tears, adhesive capsulitis, or osteoarthritis. Individuals with neurological conditions, infections, inflammatory diseases, prior major shoulder surgeries, or those who are pregnant will be excluded. After obtaining informed consent, baseline demographic and anthropometric data will be collected. Patients will be assessed during a series of experimental sessions at the Lab of Motion Analysis, where they will perform relevant activities of daily living (ADLs) with and without the assistance of a passive exoskeleton. These sessions will include evaluations of joint functionality, pain, and muscle activity using wearable sensors, EMG measurements, and kinematic analysis.

Group Type: EXPERIMENTAL

Passive Exoskeleton.

Intervention Type: DEVICE

The passive exoskeleton is used to assist patients with shoulder musculoskeletal disorders during the performance of activities of daily living (ADLs), such as overhead reaching and lifting. The device helps reduce biomechanical load and muscle strain, providing support for the shoulder joint.

Shoulder Rehabilitation with Passive Exoskeleton.

Intervention Type: PROCEDURE

The rehabilitation protocol involves the use of a passive exoskeleton during physical tasks to improve shoulder function and reduce pain. Patients perform specific exercises while wearing the exoskeleton, which is tailored to their individual needs.

Usability Assessment and Patient Satisfaction.

Intervention Type: OTHER

The usability of the passive exoskeleton is evaluated using validated scales, such as the System Usability Scale (SUS), to assess its comfort, effectiveness, and overall satisfaction. The assessment also includes patient feedback on the ease of use and perceived benefits of the device during rehabilitation sessions.

Interventions

Passive Exoskeleton.

The passive exoskeleton is used to assist patients with shoulder musculoskeletal disorders during the performance of activities of daily living (ADLs), such as overhead reaching and lifting. The device helps reduce biomechanical load and muscle strain, providing support for the shoulder joint.

Intervention Type: DEVICE

Shoulder Rehabilitation with Passive Exoskeleton.

The rehabilitation protocol involves the use of a passive exoskeleton during physical tasks to improve shoulder function and reduce pain. Patients perform specific exercises while wearing the exoskeleton, which is tailored to their individual needs.

Intervention Type: PROCEDURE

Usability Assessment and Patient Satisfaction.

The usability of the passive exoskeleton is evaluated using validated scales, such as the System Usability Scale (SUS), to assess its comfort, effectiveness, and overall satisfaction. The assessment also includes patient feedback on the ease of use and perceived benefits of the device during rehabilitation sessions.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age over 18 years.
• Employment in a physically demanding job requiring frequent upper limb activity.
• Diagnosis of one of the following conditions related to shoulder musculoskeletal disorders: rotator cuff tears, massive tears with pseudoparalytic limb, adhesive capsulitis, post-surgical outcomes following rotator cuff repair or reverse shoulder arthroplasty, and glenohumeral osteoarthritis.
• Signed informed consent.

Exclusion Criteria

• Failure to provide signed informed consent.
• Any condition that hinders the use of exoskeletons.
• Insufficient cognitive or language abilities to follow instructions provided by clinicians and/or investigators.
• Pregnancy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Campus Bio-Medico

OTHER

Sponsor Role: lead

Responsible Party

Umile Giuseppe Longo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fondazione Policlinico Universitario Campus Bio-Medico

Rome, Italy, Italy

Countries

Italy

Other Identifiers

PNC0000007 - CUP: B53C22006980

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

271.24 CET2PUDcbm

Identifier Type: -

Identifier Source: org_study_id