An interventional study of Virtual reality and Control group in Tendinopathy, Patellar Tendinopathy and Tendinopathy, Elbow, sponsored by University of Cadiz. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-10.
Sponsored by University of Cadiz · Not applicable, Interventional, and Treatment
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.
26 studies on the registry are indexed under Elbow Tendinopathy; 9 are open to participants now.
This study's planned enrollment of 120 is above the median of 40 across 23 interventional studies indexed under Elbow Tendinopathy.
Browse Elbow Tendinopathy studies →University of Cadiz is the lead sponsor of 55 studies on the registry; 9 are open to participants now.
Compared within Elbow Tendinopathy, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Tendinopathy. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Other: Control group
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
The control group will only receive their usual treatment program for the 12-week duration of the study.
Disability (Shoulder And Pain Disability Index)
Longitudinal change from 0 to 100. Higher scores mean worse outcome.
Time frame: 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.
Time frame: 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.
Time frame: Fom Baseline up to 24 Weeks Follow-up
Pain (Visual Analogue Scale)
Longitudinal change from 0 to 10. Higher scores mean worse outcome.
Time frame: Fom Baseline up to 24 Weeks Follow-up
Range of motion (Goniometer)
Longitudinal change
Time frame: Fom Baseline up to 24 Weeks Follow-up
Strength (Dynamometer)
Longitudinal change
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 Weeks and 24 Weeks
Plan to share: No
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University of Cadiz