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NCT Number: NCT06797492

Virtual Reality for Shoulder Rehabilitation

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

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Key information

Conditions

Shoulder Musculoskeletal Disorders Musculoskeletal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario Campus Bio-Medico, Roma, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shoulder Physical Examination

Diagnostic 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 Environment

Procedure

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 evaluation

Other

The usability of the VR system, along with the sense of presence and co-presence during rehabilitation, is assessed using validated scales

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

    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.

  2. 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).

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Umile Giuseppe Longo, MD, MSc, PhD

CONTACT

[email protected]

: +39 06225418816

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Campus Bio-Medico

Other

Registry information

Official study title

Virtual Reality for Shoulder Rehabilitation: New Approaches and Applications in Orthopedics

Acronym: REVISA

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 28, 2025
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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