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Enrolling by Invitation

NCT Number: NCT06842017

Passive Exoskeletons for Assisting Patients With Shoulder Musculoskeletal Disorders

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).

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Key information

Conditions

Shoulder Musculoskeletal Disorders Agnosia Musculoskeletal Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario Campus Bio-Medico

Rome, Italy, 00128

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Passive Exoskeleton.

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.

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.

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.

Primary outcomes

  1. Measurement of Joint Range of Motion (ROM)

    Time frame: 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

  2. 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

    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).

  3. Evaluation of the American Shoulder and Elbow Surgeons Score (ASES)

    Time frame: 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.

  4. 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

    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.

  5. Evaluation of the Short Form Health Survey 36 (SF-36)

    Time frame: 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.

  6. Evaluation of the Shoulder Pain and Disability Index (SPADI)

    Time frame: 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.

  7. Heart Rate evaluation with and without the exoskeleton

    Time frame: 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.

  8. Electromyographic Activity (EMG) evaluation with and without the exoskeleton

    Time frame: 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.

  9. Respiratory Rate Evaluation with and without exoskeleton

    Time frame: 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.

Secondary outcomes

  1. 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

    The usability of the passive exoskeleton will be assessed using the System Usability Scale (SUS), a standardized questionnaire consisting of ten statements rated on a five-point Likert scale from "Strongly Disagree" to "Strongly Agree." Higher scores indicate better usability.

  2. 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

    Patient satisfaction with the exoskeleton will be measured using the Technology Acceptance Model (TAM), which evaluates technology acceptability and usability, focusing on perceived ease of use and usefulness. Scores range from 0 to 100, with higher scores indicating greater acceptance and usability.

  3. 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

    Patient workload will be assessed using the NASA Task Load Index (NASA-TLX), which evaluates perceived workload across several dimensions, including mental demand, physical demand, temporal demand, performance, effort, and frustration. Scores range from 0 to 100, with higher scores indicating a greater perceived workload.

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Campus Bio-Medico

Other

Registry information

Official study title

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

Acronym: EXOADL

Important dates

Study start
2025
Primary completion
2026
Study completion
2029
First posted
Feb 24, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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