Passive Exoskeletons for Assisting Patients With Shoulder Musculoskeletal Disorders

NCT06842017 | Enrolling By Invitation

• 2 other identifiers: 271.24 CET2PUDcbmPNC0000007 - CUP: B53C22006980
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

Shoulder Musculoskeletal Disorders

Keywords

Musculoskeletal disorders; Shoulder rehabilitation; Exoskeletons; Pain management; Assistive technology; Patient outcomes; Biomechanics

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (3)

• Evaluation of the Usability Level of the passive exoskeleton using the System Usability Scale (SUS)

  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)

  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)

  a single session up to one year from the subject's enrollment

Study Arms (1)

Patients with shoulder musculoskeletal disorders

EXPERIMENTAL

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.; Procedure: Shoulder Rehabilitation with Passive Exoskeleton.; Other: Usability Assessment and Patient Satisfaction.

Interventions

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.

Patients with shoulder musculoskeletal disorders

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.

Patients with shoulder musculoskeletal disorders

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.

Patients with shoulder musculoskeletal disorders

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Campus Bio-Medico: lead

Study Sites (1)

Fondazione Policlinico Universitario Campus Bio-Medico

Rome, Italy, 00128, Italy

Location

MeSH Terms

Conditions

Musculoskeletal Diseases; Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 24, 2025
• Study Start: May 28, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2029
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)