Shoulder Musculoskeletal DisordersEXOADLNCT06842017
Passive Exoskeletons for Assisting Patients With Shoulder Musculoskeletal Disorders
A study testing Passive Exoskeleton., Shoulder Rehabilitation with Passive Exoskeleton. and Usability Assessment and Patient Satisfaction. in people with Shoulder Musculoskeletal Disorders, run by Fondazione Policlinico Universitario Campus Bio-Medico at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Musculoskeletal Disorders
- What is being tested?
- Passive Exoskeleton., Shoulder Rehabilitation with Passive Exoskeleton. and Usability Assessment and Patient Satisfaction.
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 28 May 2025to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione Policlinico Universitario Campus Bio-Medico
Rome, Italy, 00128
About this study
Official title: 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.
Read more
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).
Read the 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.
- Conditions
- Shoulder Musculoskeletal Disorders
- Being tested
- Passive Exoskeleton., Shoulder Rehabilitation with Passive Exoskeleton., Usability Assessment and Patient Satisfaction.
- Keywords
- Musculoskeletal disorders, Shoulder rehabilitation, Exoskeletons, Pain management, Assistive technology, Patient outcomes, Biomechanics
- Medical subject headings
- Musculoskeletal Diseases, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Passive Exoskeleton.; Procedure: Shoulder Rehabilitation with Passive Exoskeleton.; Other: Usability Assessment and Patient Satisfaction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: a single session up to one year from the subject's enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start28 May 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Musculoskeletal DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Campus Bio-Medico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Umile Giuseppe Longo, Fondazione Policlinico Universitario Campus Bio-Medico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06842017
- Sponsor's protocol ID
- 271.24 CET2PUDcbm
- Other IDs
- PNC0000007 - CUP: B53C22006980
- Acronym
- EXOADL
- Status last verified
- Aug 2025
- First submitted
- 11 Feb 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Passive Exoskeletons for Supporting Patients With Shoulder Musculoskeletal Disorders in Daily Activities: Assessment of Impact and User Experience
- ClinicalTrials.gov ID
- NCT06842017
- Acronym / sponsor ID
- EXOADL / 271.24 CET2PUDcbm
- Conditions
- Shoulder Musculoskeletal Disorders
- Keywords
- Musculoskeletal disorders, Shoulder rehabilitation, Exoskeletons, Pain management, Assistive technology, Patient outcomes, Biomechanics
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Campus Bio-MedicoUniversity, hospital or other
- Study start
- 28 May 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 24 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with shoulder musculoskeletal disorders | Experimental | Device: Passive Exoskeleton., Procedure: Shoulder Rehabilitation with Passive Exoskeleton., Other: Usability Assessment and Patient Satisfaction.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Patients with shoulder musculoskeletal disorders |
| 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. | Procedure or surgery | Patients with shoulder musculoskeletal disorders |
| 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. | Other | Patients with shoulder musculoskeletal disorders |
Primary outcome
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
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).
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.
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.
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.
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.
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.
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.
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.
3 secondary outcomes
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive Exoskeleton., Shoulder Rehabilitation with Passive Exoskeleton. and Usability Assessment and Patient Satisfaction. in people with Shoulder Musculoskeletal Disorders, run by Fondazione Policlinico Universitario Campus Bio-Medico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Joint Range of Motion (ROM) (time frame: a single session up to one year from the subject's enrollment). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.