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Passive Exoskeletons for Assisting Patients With Shoulder Musculoskeletal Disorders

NCT06842017 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-08-11

No results posted yet for this study

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).

Conditions

  • Shoulder Musculoskeletal Disorders

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.

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Campus Bio-Medico

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-28
Primary Completion
2026-06-30
Completion
2029-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06842017 on ClinicalTrials.gov