Virtual Reality for Shoulder Rehabilitation

NCT ID: NCT06797492

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2027-12-31

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.

Conditions

Shoulder Musculoskeletal Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients with shoulder musculoskeletal disorders

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.

Group Type: EXPERIMENTAL

Shoulder Physical Examination

Intervention Type: 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

Intervention Type: 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

Intervention Type: OTHER

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

Interventions

Shoulder Physical Examination

shoulder physical examination is conducted to assess the patient's musculoskeletal condition and to track progress throughout the rehabilitation phases

Intervention Type: DIAGNOSTIC_TEST

Shoulder Rehabilitation in a Virtual Environment

The rehabilitation protocol for shoulder disorders is executed using a Virtual Reality (VR) system, where patients perform customized exercises tailored to their physical characteristics.

Intervention Type: PROCEDURE

Usability assessment and presence and co-presence evaluation

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fondazione Policlinico Universitario Campus Bio-Medico

OTHER

Sponsor Role: lead

Responsible Party

Umile Giuseppe Longo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fondazione Policlinico Universitario Campus Bio-Medico

Rome, Italy, Italy

Countries

Italy

Central Contacts

Umile Giuseppe Longo, MD, MSc, PhD

Role: CONTACT

g.longo@policlinicocampus.it

: +39 06225418816

Other Identifiers

PNC0000007 - CUP: B53C22006980

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

234.24 CET2 cbm

Identifier Type: -

Identifier Source: org_study_id