Passive Exoskeletons for Assisting Patients With Shoulder Musculoskeletal Disorders

Official title

Passive Exoskeletons for Supporting Patients With Shoulder Musculoskeletal Disorders in Daily Activities: Assessment of Impact and User Experience

Overview

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.

Interventions

• Device 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.
• Procedure 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.
• Other 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.

Primary outcome measures

• Measurement of Joint Range of Motion (ROM) [Time frame: a single session up to one year from the subject's enrollment]
• Pain Assessment using the Visual Analogue Scale (VAS) before and after exoskeleton use [Time frame: a single session up to one year from the subject's enrollment, before and after exoskeleton use]
• Evaluation of the American Shoulder and Elbow Surgeons Score (ASES) [Time frame: a single session up to one year from the subject's enrollment]
• Evaluation of the Disabilities of the Arm, Shoulder, and Hand Score (DASH) [Time frame: a single session up to one year from the subject's enrollment]
• Evaluation of the Short Form Health Survey 36 (SF-36) [Time frame: a single session up to one year from the subject's enrollment]
• Evaluation of the Shoulder Pain and Disability Index (SPADI) [Time frame: a single session up to one year from the subject's enrollment]
• Heart Rate evaluation with and without the exoskeleton [Time frame: a single session up to one year from the subject's enrollment]
• Electromyographic Activity (EMG) evaluation with and without the exoskeleton [Time frame: a single session up to one year from the subject's enrollment]
• Respiratory Rate Evaluation with and without exoskeleton [Time frame: A single session up to one year from the subject's enrollment]

Secondary outcome measures (3)

• Evaluation of the Usability Level of the passive exoskeleton using the System Usability Scale (SUS) [Time frame: a single session up to one year from the subject's enrollment]
• Evaluation of the Patient satisfaction with the exoskeleton using the Technology Acceptance Model (TAM) [Time frame: a single session up to one year from the subject's enrollment]
• Assessment of Patient-Perceived Workload Using the NASA Task Load Index (NASA-TLX) [Time frame: a single session up to one year from the subject's enrollment]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

Italy · 1 center

• Fondazione Policlinico Universitario Campus Bio-Medico — Rome

Identifiers

NCT: NCT06842017 · 271.24 CET2PUDcbm · PNC0000007 - CUP: B53C22006980

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗