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

Primary Purpose

Tendinopathy, Patellar Tendinopathy, Tendinopathy, Elbow

Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Virtual reality
Control group
Sponsored by
University of Cadiz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tendinopathy focused on measuring virtual reality, chronic tendinopathy, physical therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Nursing and Physiotherapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

VR group

Control group

Arm Description

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.

Outcomes

Primary Outcome Measures

Disability (Shoulder And Pain Disability Index)
Longitudinal change from 0 to 100. Higher scores mean worse outcome.
Disability (Victorian Institute of Sport Assessment - Patellar)
Longitudinal change from 0 to 100. Higher scores mean better outcome.
Disability (Victorian Institute of Sport Assessment - Achilles)
Longitudinal change from 0 to 100. Higher scores mean better outcome.
Pain (Visual Analogue Scale)
Longitudinal change from 0 to 10. Higher scores mean worse outcome.

Secondary Outcome Measures

Range of motion (Goniometer)
Longitudinal change
Strength (Dynamometer)
Longitudinal change
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
Quality of Life (36-item Short Form Survey)
Longitudinal change from 0 to 100. Higher scores mean better outcome.
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.
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.

Full Information

First Posted
September 11, 2023
Last Updated
September 20, 2023
Sponsor
University of Cadiz
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1. Study Identification

Unique Protocol Identification Number
NCT06056440
Brief Title
Efficacy of a Physical Rehabilitation Program Using Virtual Reality in Patients With Chronic Tendinopathy (Virtendon-Rehab)
Acronym
VirtendonRehab
Official Title
Efficacy of a Physical Rehabilitation Program Using Virtual Reality in Patients With Chronic Tendinopathy (Virtendon-Rehab)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Cadiz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendinopathy, Patellar Tendinopathy, Tendinopathy, Elbow, Tendinopathy Rotator Cuff, Achilles Tendinopathy
Keywords
virtual reality, chronic tendinopathy, physical therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
A single-blind method will be carried out on the persons collecting and analysing the data
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VR group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Virtual reality
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
The control group will only receive their usual treatment program for the 12-week duration of the study.
Primary Outcome Measure Information:
Title
Disability (Shoulder And Pain Disability Index)
Description
Longitudinal change from 0 to 100. Higher scores mean worse outcome.
Time Frame
Fom Baseline up to 24 Weeks Follow-up
Title
Disability (Victorian Institute of Sport Assessment - Patellar)
Description
Longitudinal change from 0 to 100. Higher scores mean better outcome.
Time Frame
Fom Baseline up to 24 Weeks Follow-up
Title
Disability (Victorian Institute of Sport Assessment - Achilles)
Description
Longitudinal change from 0 to 100. Higher scores mean better outcome.
Time Frame
Fom Baseline up to 24 Weeks Follow-up
Title
Pain (Visual Analogue Scale)
Description
Longitudinal change from 0 to 10. Higher scores mean worse outcome.
Time Frame
Fom Baseline up to 24 Weeks Follow-up
Secondary Outcome Measure Information:
Title
Range of motion (Goniometer)
Description
Longitudinal change
Time Frame
Fom Baseline up to 24 Weeks Follow-up
Title
Strength (Dynamometer)
Description
Longitudinal change
Time Frame
Fom Baseline up to 24 Weeks Follow-up
Title
Kinesiophobia (Tampa Scale Questionnaire)
Description
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
Title
Quality of Life (36-item Short Form Survey)
Description
Longitudinal change from 0 to 100. Higher scores mean better outcome.
Time Frame
From Baseline up to 24 Weeks Follow-up
Title
Adherence (Exercise Adherence Rating Scale)
Description
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
Title
User satisfaction (Consumer Report Effectiveness Scale)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Lucena Anton, PhD
Phone
956015699
Ext
+34
Email
david.lucena@uca.es
Facility Information:
Facility Name
Faculty of Nursing and Physiotherapy
City
Cadiz
ZIP/Postal Code
11009
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Lucena-Anton, PhD
Phone
956015699
Ext
+34
Email
david.lucena@uca.es

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24149868
Citation
Kaux JF, Forthomme B, Goff CL, Crielaard JM, Croisier JL. Current opinions on tendinopathy. J Sports Sci Med. 2011 Jun 1;10(2):238-53.
Results Reference
background
PubMed Identifier
27852585
Citation
Mallows A, Debenham J, Walker T, Littlewood C. Association of psychological variables and outcome in tendinopathy: a systematic review. Br J Sports Med. 2017 May;51(9):743-748. doi: 10.1136/bjsports-2016-096154. Epub 2016 Nov 16.
Results Reference
background
PubMed Identifier
27810828
Citation
Chen KB, Sesto ME, Ponto K, Leonard J, Mason A, Vanderheiden G, Williams J, Radwin RG. Use of Virtual Reality Feedback for Patients with Chronic Neck Pain and Kinesiophobia. IEEE Trans Neural Syst Rehabil Eng. 2017 Aug;25(8):1240-1248. doi: 10.1109/TNSRE.2016.2621886. Epub 2016 Oct 26.
Results Reference
background
PubMed Identifier
32027185
Citation
Dominguez-Tellez P, Moral-Munoz JA, Salazar A, Casado-Fernandez E, Lucena-Anton D. Game-Based Virtual Reality Interventions to Improve Upper Limb Motor Function and Quality of Life After Stroke: Systematic Review and Meta-analysis. Games Health J. 2020 Feb;9(1):1-10. doi: 10.1089/g4h.2019.0043.
Results Reference
background
PubMed Identifier
8156067
Citation
Almekinders LC, Almekinders SV. Outcome in the treatment of chronic overuse sports injuries: a retrospective study. J Orthop Sports Phys Ther. 1994 Mar;19(3):157-61. doi: 10.2519/jospt.1994.19.3.157.
Results Reference
background
PubMed Identifier
18812414
Citation
Cook JL, Purdam CR. Is tendon pathology a continuum? A pathology model to explain the clinical presentation of load-induced tendinopathy. Br J Sports Med. 2009 Jun;43(6):409-16. doi: 10.1136/bjsm.2008.051193. Epub 2008 Sep 23.
Results Reference
background
Links:
URL
https://www.dynamics-vr.com
Description
Virtual reality software

Learn more about this trial

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

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