Shoulder Musculoskeletal DisordersREVISANCT06797492
Virtual Reality for Shoulder Rehabilitation
A study testing Shoulder Physical Examination, Shoulder Rehabilitation in a Virtual Environment and Usability assessment and presence and co-presence evaluation in people with Shoulder Musculoskeletal Disorders, run by Fondazione Policlinico Universitario Campus Bio-Medico at 2 sites in Italy.
Trial summary
Goal: The clinical investigation involves the evaluation of the usability level of the VR system, sense of presence, and co-presence during the execution of various rehabilitation exercises through specific questionnaires. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Musculoskeletal Disorders
- What is being tested?
- Shoulder Physical Examination, Shoulder Rehabilitation in a Virtual Environment and Usability assessment and presence and co-presence evaluation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Sep 2025to Dec 2027
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with shoulder musculoskeletal disorders
- Patients aged 18-75 years
- Patients who have signed informed consent
Who cannot join
- Patients with insufficient cognitive and language functions to follow instructions provided by clinicians and/or experimenters involved in the project
- Patients who do exhibit impediments that could hinder the use of VR devices
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Fondazione Policlinico Universitario Campus Bio-Medico
Roma, Italy, 00128
Umile Giuseppe Longo, PhD, 06225411, g.longo@policlinicocampus.it
- Not yet recruiting
Fondazione Policlinico Universitario Campus Bio-Medico
Rome, Italy, 00128
About this study
Official title: Virtual Reality for Shoulder Rehabilitation: New Approaches and Applications in Orthopedics
Goal: The clinical investigation involves the evaluation of the usability level of the VR system, sense of presence, and co-presence during the execution of various rehabilitation exercises through specific questionnaires.
Participant Population: The study will enroll 50 patients with shoulder musculoskeletal disorders will be enrolled
Read more
Main Questions:
- How does the integration of Virtual Reality (VR) in rehabilitation programs impact the usability of the system for patients with shoulder musculoskeletal disorders?
- To what extent does the sense of presence experienced by patients using VR systems influence their motivation and adherence to rehabilitation exercises?
- How do patients with shoulder musculoskeletal disorders perceive the co-presence in VR rehabilitation scenarios, and how does it affect their overall treatment experience?
Participant Tasks:
- Shoulder Physical Examination
- Instructions to the patient on exercises to be performed using Oculus and selection of customizable settings on the VR app
- Execution of the protocol developed for shoulder rehabilitation in a virtual environment
- Evaluation of the usability of the VR system, sense of presence, and co-presence through different validated scales
Read the detailed description
Musculoskeletal disorders are recognized globally as a primary cause of pain and physical disability. Among these, shoulder pathologies impose significant limitations, affecting patients' range of motion, quality of life, and daily functionality, often leading to substantial physical and occupational restrictions. Effective rehabilitation is essential for restoring functionality in patients with such disorders.
Traditionally, rehabilitative therapy relies on manual interventions by physiotherapists, which, while beneficial, can be hindered by logistical challenges, including limited accessibility to treatment facilities and professional availability. Additionally, at-home unsupervised exercises often suffer from low adherence due to reduced motivation and lack of engagement.
Technological advances in recent years have led to the development of novel rehabilitation strategies, particularly in virtual reality (VR) systems, which hold promising applications in musculoskeletal rehabilitation. VR provides a patient-centered, customizable approach that can adapt exercises to the individual's needs, making rehabilitation more engaging and accessible, especially for patients facing physical barriers to in-person care. Additionally, VR technology enables precise tracking of patient movements, offering an objective alternative to traditional assessments reliant on subjective observation and clinical scales.
Despite these advancements, the integration of VR into rehabilitative protocols for MSDs remains underexplored. This clinical study aims to assess the usability, sense of presence, and co-presence of VR systems in patients with shoulder musculoskeletal disorders across four rehabilitation phases. Evaluating these factors through validated questionnaires will provide critical insights into optimizing patient engagement and satisfaction, which are key to enhancing therapeutic outcomes and aligning rehabilitation interventions with patient-specific needs.
- Conditions
- Shoulder Musculoskeletal Disorders
- Being tested
- Shoulder Physical Examination, Shoulder Rehabilitation in a Virtual Environment, Usability assessment and presence and co-presence evaluation
- Keywords
- Musculoskeletal disorders, shoulder rehabilitation, virtual reality
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder Physical ExaminationDiagnostic test
shoulder physical examination is conducted to assess the patient's musculoskeletal condition and to track progress throughout the rehabilitation phases
Shoulder Rehabilitation in a Virtual EnvironmentProcedure or surgery
The rehabilitation protocol for shoulder disorders is executed using a Virtual Reality (VR) system, where patients perform customized exercises tailored to their physical characteristics.
Usability assessment and presence and co-presence evaluationOther
The usability of the VR system, along with the sense of presence and co-presence during rehabilitation, is assessed using validated scales
| Study group | Role | What they receive |
|---|---|---|
| Patients with shoulder musculoskeletal disorders | Experimental | The study will involve 50 adults with shoulder musculoskeletal disorders. Eligible participants are those over 18 with significant shoulder pathologies, excluding individuals with neurological conditions, infections, inflammatory diseases, major previous shoulder surgeries, or pregnancy. After obtaining informed consent, baseline demographic and anthropometric data will be collected. Patients will be assessed by a clinician across four rehabilitation phases: T1 (0-4/6 weeks), T2 (6-12 weeks), T3 (12-20 weeks), and T4 (beyond 20 weeks). Each phase includes a shoulder examination followed by a 30-minute VR-based rehabilitation session, customized to the patient's physical characteristics. Receives: Diagnostic Test: Shoulder Physical Examination; Procedure: Shoulder Rehabilitation in a Virtual Environment; Other: Usability assessment and presence and co-presence evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Usability Level of the VR System Using the System Usability Scale (SUS)
The usability of the VR system during the execution of several rehabilitation exercises will be assessed using the System Usability Scale (SUS). The SUS is a widely used questionnaire that measures the overall usability of a system, based on a 10-item scale that assesses the ease of use, satisfaction, and functionality of the system from the user's perspective. Scores range from 0 to 100, with higher scores indicating better usability.
Measured: Across four rehabilitation phases: T1 (0-4/6 weeks), T2 (6-12 weeks), T3 (12-20 weeks), and T4 (beyond 20 weeks)
Secondary outcomes (2)
Change in Sense of Presence Using the Igroup Presence Questionnaire (IPQ)
The sense of presence during the execution of rehabilitation exercises in the VR system will be assessed using the Igroup Presence Questionnaire (IPQ). The IPQ is a validated tool designed to measure the user's sense of immersion and involvement in a virtual environment. It includes multiple dimensions, such as spatial presence, engagement, and ecological validity, and provides insights into how "real" the virtual environment feels to the user.
Measured: The sense of presence will be evaluated across four rehabilitation phases: T1 (0-4/6 weeks), T2 (6-12 weeks), T3 (12-20 weeks), and T4 (beyond 20 weeks)
Change in Co-Presence Using the Networked Minds Social Presence Inventory
Co-presence during the execution of rehabilitation exercises in the VR system will be assessed using the Networked Minds Social Presence Inventory. This inventory measures the user's perception of social interaction and the sense of being with others in a virtual environment. It evaluates factors such as interpersonal communication, social presence, and the degree to which users feel they share the virtual space with others.
Measured: The co-presence will be assessed across four rehabilitation phases: T1 (0-4/6 weeks), T2 (6-12 weeks), T3 (12-20 weeks), and T4 (beyond 20 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start1 Sep 2025
- Primary completionJun 2026 (estimated)
- Study completionDec 2027 (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
- 50 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
- NCT06797492
- Sponsor's protocol ID
- 234.24 CET2 cbm
- Other IDs
- PNC0000007 - CUP: B53C22006980
- Acronym
- REVISA
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2025
- Last updated
- 4 Mar 2026
- 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 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality for Shoulder Rehabilitation: New Approaches and Applications in Orthopedics
- ClinicalTrials.gov ID
- NCT06797492
- Acronym / sponsor ID
- REVISA / 234.24 CET2 cbm
- Conditions
- Shoulder Musculoskeletal Disorders
- Keywords
- Musculoskeletal disorders, shoulder rehabilitation, virtual reality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Campus Bio-MedicoUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 Jan 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 involves the evaluation of the usability level of the VR system, sense of presence, and co-presence during the execution of various rehabilitation exercises through specific questionnaires.
Participant Population: The study will enroll 50 patients with shoulder musculoskeletal disorders will be enrolled
Main Questions:
- How does the integration of Virtual Reality (VR) in rehabilitation programs impact the usability of the system for patients with shoulder musculoskeletal disorders?
- To what extent does the sense of presence experienced by patients using VR systems influence their motivation and adherence to rehabilitation exercises?
- How do patients with shoulder musculoskeletal disorders perceive the co-presence in VR rehabilitation scenarios, and how does it affect their overall treatment experience?
Participant Tasks:
- Shoulder Physical Examination
- Instructions to the patient on exercises to be performed using Oculus and selection of customizable settings on the VR app
- Execution of the protocol developed for shoulder rehabilitation in a virtual environment
- Evaluation of the usability of the VR system, sense of presence, and co-presence through different validated scales
Detailed description
Musculoskeletal disorders are recognized globally as a primary cause of pain and physical disability. Among these, shoulder pathologies impose significant limitations, affecting patients' range of motion, quality of life, and daily functionality, often leading to substantial physical and occupational restrictions. Effective rehabilitation is essential for restoring functionality in patients with such disorders.
Traditionally, rehabilitative therapy relies on manual interventions by physiotherapists, which, while beneficial, can be hindered by logistical challenges, including limited accessibility to treatment facilities and professional availability. Additionally, at-home unsupervised exercises often suffer from low adherence due to reduced motivation and lack of engagement.
Technological advances in recent years have led to the development of novel rehabilitation strategies, particularly in virtual reality (VR) systems, which hold promising applications in musculoskeletal rehabilitation. VR provides a patient-centered, customizable approach that can adapt exercises to the individual's needs, making rehabilitation more engaging and accessible, especially for patients facing physical barriers to in-person care. Additionally, VR technology enables precise tracking of patient movements, offering an objective alternative to traditional assessments reliant on subjective observation and clinical scales.
Despite these advancements, the integration of VR into rehabilitative protocols for MSDs remains underexplored. This clinical study aims to assess the usability, sense of presence, and co-presence of VR systems in patients with shoulder musculoskeletal disorders across four rehabilitation phases. Evaluating these factors through validated questionnaires will provide critical insights into optimizing patient engagement and satisfaction, which are key to enhancing therapeutic outcomes and aligning rehabilitation interventions with patient-specific needs.
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 | Diagnostic Test: Shoulder Physical Examination, Procedure: Shoulder Rehabilitation in a Virtual Environment, Other: Usability assessment and presence and co-presence evaluationThe study will involve 50 adults with shoulder musculoskeletal disorders. Eligible participants are those over 18 with significant shoulder pathologies, excluding individuals with neurological conditions, infections, inflammatory diseases, major previous shoulder surgeries, or pregnancy. After obtaining informed consent, baseline demographic and anthropometric data will be collected. Patients will be assessed by a clinician across four rehabilitation phases: T1 (0-4/6 weeks), T2 (6-12 weeks), T3 (12-20 weeks), and T4 (beyond 20 weeks). Each phase includes a shoulder examination followed by a 30-minute VR-based rehabilitation session, customized to the patient's physical characteristics. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with shoulder musculoskeletal disorders
- Patients aged 18-75 years
- Patients who have signed informed consent
Key exclusion criteria (2 listed)
- Patients with insufficient cognitive and language functions to follow instructions provided by clinicians and/or experimenters involved in the project
- Patients who do exhibit impediments that could hinder the use of VR devices
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 |
|---|---|---|
| Shoulder Physical Examinationshoulder physical examination is conducted to assess the patient's musculoskeletal condition and to track progress throughout the rehabilitation phases | Diagnostic test | Patients with shoulder musculoskeletal disorders |
| Shoulder Rehabilitation in a Virtual EnvironmentThe rehabilitation protocol for shoulder disorders is executed using a Virtual Reality (VR) system, where patients perform customized exercises tailored to their physical characteristics. | Procedure or surgery | Patients with shoulder musculoskeletal disorders |
| Usability assessment and presence and co-presence evaluationThe usability of the VR system, along with the sense of presence and co-presence during rehabilitation, is assessed using validated scales | Other | Patients with shoulder musculoskeletal disorders |
Primary outcome
Change in Usability Level of the VR System Using the System Usability Scale (SUS)
Time frame: Across four rehabilitation phases: T1 (0-4/6 weeks), T2 (6-12 weeks), T3 (12-20 weeks), and T4 (beyond 20 weeks)
The usability of the VR system during the execution of several rehabilitation exercises will be assessed using the System Usability Scale (SUS). The SUS is a widely used questionnaire that measures the overall usability of a system, based on a 10-item scale that assesses the ease of use, satisfaction, and functionality of the system from the user's perspective. Scores range from 0 to 100, with higher scores indicating better usability.
2 secondary outcomes
Change in Sense of Presence Using the Igroup Presence Questionnaire (IPQ)
Time frame: The sense of presence will be evaluated across four rehabilitation phases: T1 (0-4/6 weeks), T2 (6-12 weeks), T3 (12-20 weeks), and T4 (beyond 20 weeks)
Change in Co-Presence Using the Networked Minds Social Presence Inventory
Time frame: The co-presence will be assessed across four rehabilitation phases: T1 (0-4/6 weeks), T2 (6-12 weeks), T3 (12-20 weeks), and T4 (beyond 20 weeks).
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 4 Mar 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shoulder Physical Examination, Shoulder Rehabilitation in a Virtual Environment and Usability assessment and presence and co-presence evaluation in people with Shoulder Musculoskeletal Disorders, run by Fondazione Policlinico Universitario Campus Bio-Medico at 2 sites 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Umile Giuseppe Longo, MD, MSc, PhD (: +39 06225418816, g.longo@policlinicocampus.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Usability Level of the VR System Using the System Usability Scale (SUS) (time frame: Across four rehabilitation phases: T1 (0-4/6 weeks), T2 (6-12 weeks), T3 (12-20 weeks), and T4 (beyond 20 weeks)). 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 4 Mar 2026.