Efficacy of a Physical Rehabilitation Program Using Virtual Reality in Patients With Chronic Tendinopathy (Virtendon-Rehab)
- Conditions
- Tendinopathy Rotator CuffAchilles TendinopathyPatellar TendinopathyTendinopathy, ElbowTendinopathy
- Interventions
- Other: Control groupProcedure: Virtual reality
- Registration Number
- NCT06056440
- Lead Sponsor
- University of Cadiz
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- Clinical diagnosis of tendinopathy (shoulder rotator cuff tendinopathy, epicondylitis/epicondylitis, patellar tendinopathy, achilles tendinopathy).
- Duration of symptoms: greater than 6 weeks.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Control group - VR group Virtual reality 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.
- Primary Outcome Measures
Name Time Method Disability (Victorian Institute of Sport Assessment - Patellar) Fom Baseline up to 24 Weeks Follow-up Longitudinal change from 0 to 100. Higher scores mean better outcome.
Pain (Visual Analogue Scale) Fom Baseline up to 24 Weeks Follow-up Longitudinal change from 0 to 10. Higher scores mean worse outcome.
Disability (Shoulder And Pain Disability Index) Fom Baseline up to 24 Weeks Follow-up Longitudinal change from 0 to 100. Higher scores mean worse outcome.
Disability (Victorian Institute of Sport Assessment - Achilles) Fom Baseline up to 24 Weeks Follow-up Longitudinal change from 0 to 100. Higher scores mean better outcome.
- Secondary Outcome Measures
Name Time Method Quality of Life (36-item Short Form Survey) From Baseline up to 24 Weeks Follow-up Longitudinal change from 0 to 100. Higher scores mean better outcome.
User satisfaction (Consumer Report Effectiveness Scale) 12 Weeks and 24 Weeks Global satisfaction with the treatment received. 3-item scale scoring from 0 to 300. Higher scores mean better outcome.
Strength (Dynamometer) Fom Baseline up to 24 Weeks Follow-up Longitudinal change
Kinesiophobia (Tampa Scale Questionnaire) From Baseline up to 24 Weeks Follow-up 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
Range of motion (Goniometer) Fom Baseline up to 24 Weeks Follow-up Longitudinal change
Adherence (Exercise Adherence Rating Scale) 12 Weeks and 24 Weeks 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.
Trial Locations
- Locations (1)
Faculty of Nursing and Physiotherapy
🇪🇸Cadiz, Spain