Virtual Reality for Shoulder Rehabilitation

NCT06797492 | Recruiting

• 2 other identifiers: 234.24 CET2 cbmPNC0000007 - CUP: B53C22006980
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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

Conditions

Shoulder Musculoskeletal Disorders

Keywords

Musculoskeletal disorders; shoulder rehabilitation; virtual reality

Outcome Measures

Primary Outcomes (1)

• 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.

  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 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

  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).

Study Arms (1)

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.

Diagnostic Test: Shoulder Physical Examination; Procedure: Shoulder Rehabilitation in a Virtual Environment; Other: Usability assessment and presence and co-presence evaluation

Interventions

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

Patients with shoulder musculoskeletal disorders

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.

Patients with shoulder musculoskeletal disorders

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

Patients with shoulder musculoskeletal disorders

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Campus Bio-Medico: lead

Study Sites (2)

Fondazione Policlinico Universitario Campus Bio-Medico

Roma, Italy, 00128, Italy

RECRUITING

Fondazione Policlinico Universitario Campus Bio-Medico

Rome, Italy, 00128, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Musculoskeletal Diseases

Central Study Contacts

Umile Giuseppe Longo, MD, MSc, PhD

CONTACT

: +39 06225418816; g.longo@policlinicocampus.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 28, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

IT (2)