Virtual Reality for Shoulder Rehabilitation

Not Applicable

Not yet recruiting

• Conditions: Shoulder Musculoskeletal Disorders

• Registration Number: NCT06797492
• Lead Sponsor: Fondazione Policlinico Universitario Campus Bio-Medico

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-22
• Study First Submitted QC: 2025-01-22
• Last Update Submitted: 2025-01-22
• Study First Posted: 2025-01-28
• Last Update Posted: 2025-01-28
• Study Start: 2025-09
• Primary Completion: 2026-06
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Usability Level of the VR System Using the System Usability Scale (SUS)	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.

Secondary Outcome Measures

Name	Time	Method
Change in Sense of Presence Using the Igroup Presence Questionnaire (IPQ)	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)	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.
Change in Co-Presence Using the Networked Minds Social Presence Inventory	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).	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.

Trial Locations

Locations (1)

Fondazione Policlinico Universitario Campus Bio-Medico; 🇮🇹 Rome, Italy