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Clinical Trials/NCT06056440
NCT06056440
Recruiting
Not Applicable

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

University of Cadiz1 site in 1 country120 target enrollmentNovember 28, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tendinopathy
Sponsor
University of Cadiz
Enrollment
120
Locations
1
Primary Endpoint
Disability (Victorian Institute of Sport Assessment - Patellar)
Status
Recruiting
Last Updated
last year

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.

Registry
clinicaltrials.gov
Start Date
November 28, 2023
End Date
December 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Disability (Victorian Institute of Sport Assessment - Patellar)

Time Frame: Fom Baseline up to 24 Weeks Follow-up

Longitudinal change from 0 to 100. Higher scores mean better outcome.

Pain (Visual Analogue Scale)

Time Frame: 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)

Time Frame: 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)

Time Frame: Fom Baseline up to 24 Weeks Follow-up

Longitudinal change from 0 to 100. Higher scores mean better outcome.

Secondary Outcomes

  • Quality of Life (36-item Short Form Survey)(From Baseline up to 24 Weeks Follow-up)
  • User satisfaction (Consumer Report Effectiveness Scale)(12 Weeks and 24 Weeks)
  • Strength (Dynamometer)(Fom Baseline up to 24 Weeks Follow-up)
  • Kinesiophobia (Tampa Scale Questionnaire)(From Baseline up to 24 Weeks Follow-up)
  • Range of motion (Goniometer)(Fom Baseline up to 24 Weeks Follow-up)
  • Adherence (Exercise Adherence Rating Scale)(12 Weeks and 24 Weeks)

Study Sites (1)

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