Passive Exoskeletons for Assisting Patients With Shoulder Musculoskeletal Disorders

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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.

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).

Eligibility

Primary outcome measure(s)

• Measurement of Joint Range of Motion (ROM) — a single session up to one year from the subject's enrollment
  Joint Range of Motion (ROM) will be evaluated using stereophotogrammetric systems, and wearable sensors during the execution of movements with and without the exoskeleton
• Pain Assessment using the Visual Analogue Scale (VAS) before and after exoskeleton use — a single session up to one year from the subject's enrollment, before and after exoskeleton use
  Pain levels will be measured using the Visual Analogue Scale (VAS) before and after exoskeleton use. The VAS provides a quantitative measure of pain intensity, with scores ranging from 0 (no pain) to 10 (worst pain imaginable).
• Evaluation of the American Shoulder and Elbow Surgeons Score (ASES) — a single session up to one year from the subject's enrollment
  The ASES score will be used to evaluate shoulder function and pain. This clinical scale assesses both pain and the ability to perform daily activities, with higher scores indicating better function. The total score ranges from 0 to 100, with 0 representing the worst shoulder function and 100 indicating the best possible outcome.
• Evaluation of the Disabilities of the Arm, Shoulder, and Hand Score (DASH) — a single session up to one year from the subject's enrollment
  The DASH questionnaire will assess disability and symptoms in people with upper limb musculoskeletal disorders. Higher scores indicate greater disability. The total score ranges from 0 to 100, with 0 representing no disability and 100 indicating the most severe disability.
• Evaluation of the Short Form Health Survey 36 (SF-36) — a single session up to one year from the subject's enrollment
  The SF-36 will evaluate overall health-related quality of life, covering physical functioning, bodily pain, and general health perceptions. Higher scores indicate better health status. The total score ranges from 0 to 100, with 0 representing the poorest health status and 100 indicating the best possible health status.
• Evaluation of the Shoulder Pain and Disability Index (SPADI) — a single session up to one year from the subject's enrollment
  The SPADI will measure pain and disability associated with shoulder pathology. It consists of two subscales: pain and disability, with higher scores indicating greater impairment. The total score ranges from 0 to 100, with 0 representing no impairment and 100 indicating the most severe impairment.
• Heart Rate evaluation with and without the exoskeleton — a single session up to one year from the subject's enrollment
  Heart rate will be monitored using wearable sensors during tasks performed with and without the exoskeleton. The heart rate will be recorded in beats per minute to evaluate the physiological response to movement efficiency and task execution.
• Electromyographic Activity (EMG) evaluation with and without the exoskeleton — a single session up to one year from the subject's enrollment
  Muscle activity in key shoulder muscles, such as the anterior deltoid and upper trapezius, will be measured using electromyographic (EMG) sensors during movement execution with and without the exoskeleton. The EMG signal will be recorded in millivolts (mV) to quantify the level of muscle activation and the physiological response during movement execution.
• Respiratory Rate Evaluation with and without exoskeleton — A single session up to one year from the subject's enrollment
  Respiratory rate will be monitored using wearable sensors during tasks performed with and without the exoskeleton. The respiratory rate will be recorded in breaths per minute to assess the physiological response and efficiency of breathing during movement execution.

Trial sites (1)

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