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

NCT ID: NCT06056440

Last Updated: 2024-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-28

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Tendinopathy Patellar Tendinopathy Tendinopathy, Elbow Tendinopathy Rotator Cuff Achilles Tendinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
A single-blind method will be carried out on the persons collecting and analysing the data

Study Groups

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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.

Group Type EXPERIMENTAL

Virtual reality

Intervention Type PROCEDURE

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

Control group

Group Type OTHER

Control group

Intervention Type OTHER

The control group will only receive their usual treatment program for the 12-week duration of the study.

Interventions

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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

Intervention Type PROCEDURE

Control group

The control group will only receive their usual treatment program for the 12-week duration of the study.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cadiz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Faculty of Nursing and Physiotherapy

Cadiz, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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David Lucena Anton, PhD

Role: CONTACT

956015699 ext. +34

Facility Contacts

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David Lucena-Anton, PhD

Role: primary

956015699 ext. +34

References

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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.

Reference Type BACKGROUND
PMID: 24149868 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27852585 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27810828 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32027185 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8156067 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18812414 (View on PubMed)

Lucena-Anton D, Dominguez-Romero JG, Chacon-Barba JC, Santi-Cano MJ, Luque-Moreno C, Moral-Munoz JA. Efficacy of a physical rehabilitation program using virtual reality in patients with chronic tendinopathy: A randomized controlled trial protocol (VirTendon-Rehab). Digit Health. 2025 Feb 18;11:20552076241297043. doi: 10.1177/20552076241297043. eCollection 2025 Jan-Dec.

Reference Type DERIVED
PMID: 39974760 (View on PubMed)

Related Links

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https://www.dynamics-vr.com

Virtual reality software

Other Identifiers

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PR2022-049

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

University of Cadiz PR2022-049

Identifier Type: -

Identifier Source: org_study_id

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