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

University of Cadiz

Status: Enrolling

Conditions: Achilles Tendinopathy; Tendinopathy Rotator Cuff; Patellar Tendinopathy; Tendinopathy; Tendinopathy, Elbow

Treatments: Other: Control group; Procedure: Virtual reality

Study type: Interventional

Funder types: Other

Identifiers

NCT06056440

PR2022-049 (Other Grant/Funding Number)

University of Cadiz PR2022-049

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of tendinopathy (shoulder rotator cuff tendinopathy, epicondylitis/epicondylitis, patellar tendinopathy, achilles tendinopathy).
• Duration of symptoms: greater than 6 weeks.

Exclusion criteria

• People who have any pathology that prevents them from performing physical exercise.
• Persons who have undergone surgery.
• Persons who have an illness that may be a contraindication to the proposed procedure.
• Persons who have received exercise therapy in the last 3 months.
• Persons who have received corticosteroid injections in the last 3 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

120 participants in 2 patient groups

VR group

Experimental group

Description:

The VR intervention program for the experimental group will be carried through 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. This VR intervention will be performed in addition to the patient's usual treatment program.

Treatment:

Procedure: Virtual reality

Control group

Other group

Treatment:

Other: Control group