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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Tendinopathy, Patellar Tendinopathy, Tendinopathy, Elbow, Tendinopathy Rotator Cuff, Achilles Tendinopathy

Intervention / Treatment
-----------------
* Procedure: Virtual reality
* Other: Control group


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VR group<br>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. | Procedure: Virtual reality<br>* 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<br>|
| Other: Control group<br> | Other: Control group<br>* The control group will only receive their usual treatment program for the 12-week duration of the study.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability (Shoulder And Pain Disability Index) | Longitudinal change from 0 to 100. Higher scores mean worse outcome. | Fom Baseline up to 24 Weeks Follow-up | 
| Disability (Victorian Institute of Sport Assessment - Patellar) | Longitudinal change from 0 to 100. Higher scores mean better outcome. | Fom Baseline up to 24 Weeks Follow-up | 
| Disability (Victorian Institute of Sport Assessment - Achilles) | Longitudinal change from 0 to 100. Higher scores mean better outcome. | Fom Baseline up to 24 Weeks Follow-up | 
| Pain (Visual Analogue Scale) | Longitudinal change from 0 to 10. Higher scores mean worse outcome. | Fom Baseline up to 24 Weeks Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of motion (Goniometer) | Longitudinal change | Fom Baseline up to 24 Weeks Follow-up | 
| Strength (Dynamometer) | Longitudinal change | Fom Baseline up to 24 Weeks Follow-up | 
| Kinesiophobia (Tampa Scale Questionnaire) | Longitudinal change from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia | From Baseline up to 24 Weeks Follow-up | 
| Quality of Life (36-item Short Form Survey) | Longitudinal change from 0 to 100. Higher scores mean better outcome. | From Baseline up to 24 Weeks Follow-up | 
| Adherence (Exercise Adherence Rating Scale) | The original English version of the EARS is a 16-item, self-reported questionnaire, which assessadherence of prescribed exercises [6]. The EARS consist of 3 sections. Section 'A' is about prescribedexercise questionnaire. This section consists of 5 questions, which are related to way of doing activitiesand exercise that people often do to improve their physical quality of life. Section 'B' is about exerciseadherence behavior, so called exercise adherence rating scale. This section consists of 6 items, which isan actual measure to identify exercise adherence. This evaluates whether individuals do their exercise asper recommendation or not. Section 'C' is about reasons for adherence/non-adherence of exercises. Thissection consists of 10 items, which assesses factors that hinders and facilitates the exercises. Higher scores mean better outcome. | 12 Weeks and 24 Weeks | 
| User satisfaction (Consumer Report Effectiveness Scale) | Global satisfaction with the treatment received. 3-item scale scoring from 0 to 300. Higher scores mean better outcome. | 12 Weeks and 24 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
virtual reality, chronic tendinopathy, physical therapy