Clinical trial NCT06797492: Virtual Reality for Shoulder Rehabilitation
Official title: Virtual Reality for Shoulder Rehabilitation: New Approaches and Applications in Orthopedics
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Shoulder Musculoskeletal Disorders
Keywords: Musculoskeletal disorders
shoulder rehabilitation
virtual reality
Lead sponsor: Fondazione Policlinico Universitario Campus Bio-Medico
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Patients with shoulder musculoskeletal disorders
* Patients aged 18-75 years
* Patients who have signed informed consent

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Usability Level of the VR System Using the System Usability Scale (SUS)
timeFrame: Across four rehabilitation phases: T1 (0-4/6 weeks), T2 (6-12 weeks), T3 (12-20 weeks), and T4 (beyond 20 weeks)
Secondary outcomes:
measure: Change in Sense of Presence Using the Igroup Presence Questionnaire (IPQ)
timeFrame: 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)
measure: Change in Co-Presence Using the Networked Minds Social Presence Inventory
timeFrame: 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).
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Campus Bio-Medico
Study officials:
References: