NCT06056440

Efficacy of a Physical Rehabilitation Program Using Virtual Reality in Patients With Chronic Tendinopathy (Virtendon-Rehab)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University of Cadiz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Chronic tendinopathies (CT) have a high prevalence (30% of musculoskeletal injuries), causing pain, decreased physical activity and functionality, as well as limitations in daily life. Virtual reality (VR) fosters patient recovery through playful activities that promote competitiveness, stimulates motivation and continuous attention, allows individualizing the exercise program, objectively assessing the execution of the treatment and monitoring the patient's evolution. Therefore, the VIRTENDON-REHAB project aims to conduct a low-risk randomized controlled clinical trial to analyze the efficacy of a VR-based physical rehabilitation program in a population diagnosed with CT on pain, functionality, range of motion, strength, muscle activation pattern, kinesiophobia, quality of life, adherence to treatment and patient satisfaction with the use of the system, compared to a control group. Likewise, the aim is to characterize the clinical profile of this population and to know the relationships between the previous variables. Measurements will be taken at the beginning of the intervention, at the end (12 weeks) and 3 months after the end of the intervention. A descriptive analysis will be performed, inter- and intra-group differences will be analyzed by means of t-Student, Wilcoxon, Mann-Whitney U and mixed ANOVA tests. Cohen's d will be used to determine the effect size. Relationships between variables will be analyzed using structural equations. The results obtained will allow improving knowledge on the management of CT using VR, as well as improving clinical care and reducing healthcare costs.

Conditions

• Tendinopathy
• Patellar Tendinopathy
• Tendinopathy, Elbow
• Tendinopathy Rotator Cuff
• Achilles Tendinopathy

Interventions

Type	Name	Description
PROCEDURE	Virtual reality	The VR intervention program for the experimental group will be carried out with a frequency of 3 sessions/week, duration of approximately 45 minutes, and for a total of 12 weeks, being performed in addition to the patient's usual treatment program. The Oculus Quest 2 device (which consists of VR glasses and different accessories) will be used, in conjunction with software specifically designed for physical rehabilitation of upper and lower limbs: Dynamics VR. Specifically, the specific functional rehabilitation program will be used, which comprises exercises that are easy to perform, with a playful component, and which encourage the patient's continuous attention to the task performed, acting as a distractor phenomenon in the face of restrictive movement factors such as fear of pain or movement. This software offers the possibility of adjusting the number of repetitions and characteristics of the exercises, thus allowing an individualized physical rehabilitation
OTHER	Control group	The control group will only receive their usual treatment program for the 12-week duration of the study.

Timeline

• Start date: 2023-11-28
• Primary completion: 2024-11-01
• Completion: 2024-12-01
• First posted: 2023-09-28
• Last updated: 2024-05-10

Locations

1 site across 1 country: Spain