Clinical trial NCT06842017: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Shoulder Musculoskeletal Disorders
Keywords: Musculoskeletal disorders
Shoulder rehabilitation
Exoskeletons
Pain management
Assistive technology
Patient outcomes
Biomechanics
Lead sponsor: Fondazione Policlinico Universitario Campus Bio-Medico
Sponsor class: OTHER
First posted: 2025-02-24
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Measurement of Joint Range of Motion (ROM)
timeFrame: a single session up to one year from the subject's enrollment
measure: Pain Assessment using the Visual Analogue Scale (VAS) before and after exoskeleton use
timeFrame: a single session up to one year from the subject's enrollment, before and after exoskeleton use
measure: Evaluation of the American Shoulder and Elbow Surgeons Score (ASES)
timeFrame: a single session up to one year from the subject's enrollment
measure: Evaluation of the Disabilities of the Arm, Shoulder, and Hand Score (DASH)
timeFrame: a single session up to one year from the subject's enrollment
measure: Evaluation of the Short Form Health Survey 36 (SF-36)
timeFrame: a single session up to one year from the subject's enrollment
measure: Evaluation of the Shoulder Pain and Disability Index (SPADI)
timeFrame: a single session up to one year from the subject's enrollment
measure: Heart Rate evaluation with and without the exoskeleton
timeFrame: a single session up to one year from the subject's enrollment
measure: Electromyographic Activity (EMG) evaluation with and without the exoskeleton
timeFrame: a single session up to one year from the subject's enrollment
measure: Respiratory Rate Evaluation with and without exoskeleton
timeFrame: A single session up to one year from the subject's enrollment
Secondary outcomes:
measure: Evaluation of the Usability Level of the passive exoskeleton using the System Usability Scale (SUS)
timeFrame: a single session up to one year from the subject's enrollment
measure: Evaluation of the Patient satisfaction with the exoskeleton using the Technology Acceptance Model (TAM)
timeFrame: a single session up to one year from the subject's enrollment
measure: Assessment of Patient-Perceived Workload Using the NASA Task Load Index (NASA-TLX)
timeFrame: a single session up to one year from the subject's enrollment
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Campus Bio-Medico
Study officials:
References: