Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-26 @ 7:28 PM
Study NCT ID:
NCT06797492
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-28
First Post:
2025-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality for Shoulder Rehabilitation
Sponsor:
Fondazione Policlinico Universitario Campus Bio-Medico
Organization:
Study Overview
Official Title:
Virtual Reality for Shoulder Rehabilitation: New Approaches and Applications in Orthopedics
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REVISA
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
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| PNC0000007 - CUP: B53C22006980 | OTHER_GRANT | Italian Ministry of Research, under the complementary actions to the NRRP "Fit4MedRob - Fit for Medical Robotics" | View |