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

September 20, 2023 updated by: University of Cadiz
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Cadiz, Spain, 11009
        • Faculty of Nursing and Physiotherapy
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control group
Other: Control group
The control group will only receive their usual treatment program for the 12-week duration of the study.
Experimental: VR group
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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Fom Baseline up to 24 Weeks Follow-up
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.
Fom Baseline up to 24 Weeks Follow-up
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.
Fom Baseline up to 24 Weeks Follow-up
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.
Fom Baseline up to 24 Weeks Follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of motion (Goniometer)
Time Frame: Fom Baseline up to 24 Weeks Follow-up
Longitudinal change
Fom Baseline up to 24 Weeks Follow-up
Strength (Dynamometer)
Time Frame: Fom Baseline up to 24 Weeks Follow-up
Longitudinal change
Fom Baseline up to 24 Weeks Follow-up
Kinesiophobia (Tampa Scale Questionnaire)
Time Frame: 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
From Baseline up to 24 Weeks Follow-up
Quality of Life (36-item Short Form Survey)
Time Frame: From Baseline up to 24 Weeks Follow-up
Longitudinal change from 0 to 100. Higher scores mean better outcome.
From Baseline up to 24 Weeks Follow-up
Adherence (Exercise Adherence Rating Scale)
Time Frame: 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.
12 Weeks and 24 Weeks
User satisfaction (Consumer Report Effectiveness Scale)
Time Frame: 12 Weeks and 24 Weeks
Global satisfaction with the treatment received. 3-item scale scoring from 0 to 300. Higher scores mean better outcome.
12 Weeks and 24 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cadiz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

September 11, 2023

First Submitted That Met QC Criteria

September 20, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • University of Cadiz PR2022-049
  • PR2022-049 (Other Grant/Funding Number: University of Cadiz)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tendinopathy

Clinical Trials on Virtual reality

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe