Passive Exoskeletons for Assisting Patients With Shoulder Musculoskeletal Disorders (EXOADL)

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

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Shoulder Musculoskeletal Disorders
• Intervention / Treatment: Device: Passive Exoskeleton.; Procedure: Shoulder Rehabilitation with Passive Exoskeleton.; Other: Usability Assessment and Patient Satisfaction.

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.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00128
    • Fondazione Policlinico Universitario Campus Bio-medico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients with shoulder musculoskeletal disorders; The study will involve 15 adults with shoulder musculoskeletal disorders. Eligible participants must be over 18 years old and diagnosed with conditions such as rotator cuff tears, adhesive capsulitis, or osteoarthritis. Individuals with neurological conditions, infections, inflammatory diseases, prior major shoulder surgeries, or those who are pregnant will be excluded. After obtaining informed consent, baseline demographic and anthropometric data will be collected. Patients will be assessed during a series of experimental sessions at the Lab of Motion Analysis, where they will perform relevant activities of daily living (ADLs) with and without the assistance of a passive exoskeleton. These sessions will include evaluations of joint functionality, pain, and muscle activity using wearable sensors, EMG measurements, and kinematic analysis.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of Joint Range of Motion (ROM)	Joint Range of Motion (ROM) will be evaluated using stereophotogrammetric systems, and wearable sensors during the execution of movements with and without the exoskeleton	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	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).	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)	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.	a single session up to one year from the subject's enrollment
Evaluation of the Disabilities of the Arm, Shoulder, and Hand Score (DASH)	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.	a single session up to one year from the subject's enrollment
Evaluation of the Short Form Health Survey 36 (SF-36)	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.	a single session up to one year from the subject's enrollment
Evaluation of the Shoulder Pain and Disability Index (SPADI)	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.	a single session up to one year from the subject's enrollment
Heart Rate evaluation with and without the exoskeleton	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.	a single session up to one year from the subject's enrollment
Electromyographic Activity (EMG) evaluation with and without the exoskeleton	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.	a single session up to one year from the subject's enrollment
Respiratory Rate Evaluation with and without exoskeleton	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.	A single session up to one year from the subject's enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the Usability Level of the passive exoskeleton using the System Usability Scale (SUS)	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.	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)	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.	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)	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.	a single session up to one year from the subject's enrollment

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Campus Bio-Medico

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: February 11, 2025
• First Submitted That Met QC Criteria: February 18, 2025
• First Posted (Actual): February 24, 2025

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 5, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Assistive technology; Pain management; Biomechanics; Shoulder rehabilitation; Patient outcomes; Musculoskeletal disorders; Exoskeletons
• Additional Relevant MeSH Terms: Musculoskeletal Diseases
• Other Study ID Numbers: 271.24 CET2PUDcbm; PNC0000007 - CUP: B53C22006980 (Other Grant/Funding Number: Italian Ministry of Research, under the complementary actions to the NRRP "Fit4MedRob - Fit for Medical Robotics")

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The ownership of the data is of the promoter and shared with the investigators and will be managed according to the agreements between the participating institutions and with the researchers. Data Property belongs to Fondazione Policlinico Universitario Campus Bio-Medico. The personnel involved in this study will have access to all data. In agreement with the ICH-GCP, the principal investigator of the study agrees to produce a report on the study, share all the data collected as described in the Protocol, and ensure that the data are reported responsibly and consistently.

The transmission or dissemination of data through scientific publications and/or presentations in congresses, conferences, seminars, and participation in multicenter studies will take place exclusively following a purely statistical processing of the same, or in any case, in an anonymous form.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No