Virtual Reality in Orthopedic Rehabilitation

NCT ID: NCT06002139

Last Updated: 2023-12-12

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

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2023-10-01

Brief Summary

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The study's objective is to evaluate the efficacy of implemented Virtual Reality therapy for patients who have undergone lower limb arthroplasty and are in inpatient rehabilitation. The study aim to examine its influence on reducing anxiety levels, mitigating depressive symptoms, enhancing motivation for elderly patients to participate in physiotherapy, and improving their overall functional state and fall risk.

Detailed Description

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The study will include elderly patients (60+) who present sequentially at the General Systemic Rehabilitation Department of St. Hedwig of Silesia Hospital in Trzebnica, within 3 months of having undergone hip or knee joint arthroplasty surgery. Patients will be randomly assigned to one of two groups: A. Virtual Reality Group: 8 therapy sessions, two sessions per week; B. Control group, undergoing conventional rehabilitation. Participation in the study is entirely voluntary, and written consent is required.

Conditions

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Arthropathy Anxiety Stress

Keywords

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arthroplasty stress fall risk depression anxiety self-efficacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Immersive Virtual Reality Therapy

Conventional orthopedic rehabilitation supplemented by VR therapy

Group Type EXPERIMENTAL

Immersive Virtual Reality Therapy

Intervention Type BEHAVIORAL

8 sessions of VR therapy over 4 weeks (each of them 20 minutes long).

As a virtual reality source, VRTierOne device (Stolgraf®) were used. Thanks to using head mounted display and the phenomenon of total immersion VR therapy provides an intense visual, auditory and kinesthetic stimulation. It can have a calming and mood-improving effect or help the patients recognize their psychological resources and motivate to the rehabilitation process. In the virtual therapeutic garden there are a rich set of symbols and metaphors based on Ericksonian Psychotherapy approach. The most important is the Garden of Revival which symbolizes the patient's health. It used to be full of life and energy, now it is neglected, requires work to be revived. In the therapeutic process day by day, the therapist tells the patient a symbolic story about his/her situation.

Conventional rehabilitation

Intervention Type BEHAVIORAL

Four weeks of conventional rehabilitation including:

* Two hours of kinesiotherapy (120 minutes, including gait training).
* Thirty minutes of ergotherapy.
* Three physical therapy procedures (i.e. laser therapy, magnetic therapy, electrotherapy) tailored to individual ailments and needs.

Conventional rehabilitation

Conventional orthopedic rehabilitation

Group Type ACTIVE_COMPARATOR

Conventional rehabilitation

Intervention Type BEHAVIORAL

Four weeks of conventional rehabilitation including:

* Two hours of kinesiotherapy (120 minutes, including gait training).
* Thirty minutes of ergotherapy.
* Three physical therapy procedures (i.e. laser therapy, magnetic therapy, electrotherapy) tailored to individual ailments and needs.

Interventions

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Immersive Virtual Reality Therapy

8 sessions of VR therapy over 4 weeks (each of them 20 minutes long).

As a virtual reality source, VRTierOne device (Stolgraf®) were used. Thanks to using head mounted display and the phenomenon of total immersion VR therapy provides an intense visual, auditory and kinesthetic stimulation. It can have a calming and mood-improving effect or help the patients recognize their psychological resources and motivate to the rehabilitation process. In the virtual therapeutic garden there are a rich set of symbols and metaphors based on Ericksonian Psychotherapy approach. The most important is the Garden of Revival which symbolizes the patient's health. It used to be full of life and energy, now it is neglected, requires work to be revived. In the therapeutic process day by day, the therapist tells the patient a symbolic story about his/her situation.

Intervention Type BEHAVIORAL

Conventional rehabilitation

Four weeks of conventional rehabilitation including:

* Two hours of kinesiotherapy (120 minutes, including gait training).
* Thirty minutes of ergotherapy.
* Three physical therapy procedures (i.e. laser therapy, magnetic therapy, electrotherapy) tailored to individual ailments and needs.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Individuals who have recently undergone hip or knee joint arthroplasty surgeries aged 60 years and above.

Exclusion Criteria

* cognitive impairments that prevent independent completion of research questionnaires
* reported consciousness disorders
* bipolar affective disorder and other serious mental disorders in the patient's medical history
* use of psychoactive drugs
* ongoing psychiatric treatment or individual psychological therapy
* contraindications to Virtual Reality such as epilepsy, vertigo, serious vision disorders
* functional status preventing independent movement (orthopedic aids are allowed, e.g., crutches, walker)
* refusal to participate in the study at any stage
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wroclaw Medical University

OTHER

Sponsor Role collaborator

Wroclaw University of Health and Sport Sciences

OTHER

Sponsor Role collaborator

Jan Dlugosz University in Czestochowa

OTHER

Sponsor Role collaborator

Joanna Szczepańska-Gieracha

OTHER

Sponsor Role lead

Responsible Party

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Joanna Szczepańska-Gieracha

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Justyna Mazurek, PhD

Role: STUDY_CHAIR

Wroclaw Medical University

Błażej Cieślik, PhD

Role: STUDY_CHAIR

Jan Dlugosz University in Czestochowa, Poland

Justyna Mazurek, RhD

Role: PRINCIPAL_INVESTIGATOR

Wroclaw Medical University

Joanna Szczepańska-Gieracha, Professor

Role: STUDY_DIRECTOR

Wrocław University of Health and Sport Sciences

Robert Gajda, PhD

Role: STUDY_DIRECTOR

Gajda-Med District Hospital in Pułtusk

Locations

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St. Hedwig of Silesia Hospital in Trzebnica

Trzebnica, Lower Silesian Voivodeship, Poland

Site Status

Countries

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Poland

References

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Cieslik B, Mazurek J, Rutkowski S, Kiper P, Turolla A, Szczepanska-Gieracha J. Virtual reality in psychiatric disorders: A systematic review of reviews. Complement Ther Med. 2020 Aug;52:102480. doi: 10.1016/j.ctim.2020.102480. Epub 2020 Jun 9.

Reference Type BACKGROUND
PMID: 32951730 (View on PubMed)

Rutkowski S, Kiper P, Cacciante L, Cieslik B, Mazurek J, Turolla A, Szczepanska-Gieracha J. Use of virtual reality-based training in different fields of rehabilitation: A systematic review and meta-analysis. J Rehabil Med. 2020 Nov 19;52(11):jrm00121. doi: 10.2340/16501977-2755.

Reference Type BACKGROUND
PMID: 33073855 (View on PubMed)

Kiper P, Przysiezna E, Cieslik B, Broniec-Siekaniec K, Kucinska A, Szczygiel J, Turek K, Gajda R, Szczepanska-Gieracha J. Effects of Immersive Virtual Therapy as a Method Supporting Recovery of Depressive Symptoms in Post-Stroke Rehabilitation: Randomized Controlled Trial. Clin Interv Aging. 2022 Nov 23;17:1673-1685. doi: 10.2147/CIA.S375754. eCollection 2022.

Reference Type BACKGROUND
PMID: 36447623 (View on PubMed)

Szczepanska-Gieracha J, Cieslik B, Rutkowski S, Kiper P, Turolla A. What can virtual reality offer to stroke patients? A narrative review of the literature. NeuroRehabilitation. 2020;47(2):109-120. doi: 10.3233/NRE-203209.

Reference Type BACKGROUND
PMID: 32741792 (View on PubMed)

Czech O, Siewierska K, Krzywinska A, Skorniak J, Maciejczyk A, Matkowski R, Szczepanska-Gieracha J, Malicka I. Virtual Therapy Complementary Prehabilitation of Women Diagnosed with Breast Cancer-A Pilot Study. Int J Environ Res Public Health. 2022 Dec 30;20(1):722. doi: 10.3390/ijerph20010722.

Reference Type BACKGROUND
PMID: 36613047 (View on PubMed)

Szczepanska-Gieracha J, Jozwik S, Cieslik B, Mazurek J, Gajda R. Immersive Virtual Reality Therapy as a Support for Cardiac Rehabilitation: A Pilot Randomized-Controlled Trial. Cyberpsychol Behav Soc Netw. 2021 Aug;24(8):543-549. doi: 10.1089/cyber.2020.0297. Epub 2021 Feb 11.

Reference Type BACKGROUND
PMID: 33577375 (View on PubMed)

Cieslik B, Juszko K, Kiper P, Szczepanska-Gieracha J. Immersive virtual reality as support for the mental health of elderly women: a randomized controlled trial. Virtual Real. 2023 May 7:1-9. doi: 10.1007/s10055-023-00797-w. Online ahead of print.

Reference Type BACKGROUND
PMID: 37360811 (View on PubMed)

Rutkowski S, Szczegielniak J, Szczepanska-Gieracha J. Evaluation of the Efficacy of Immersive Virtual Reality Therapy as a Method Supporting Pulmonary Rehabilitation: A Randomized Controlled Trial. J Clin Med. 2021 Jan 18;10(2):352. doi: 10.3390/jcm10020352.

Reference Type BACKGROUND
PMID: 33477733 (View on PubMed)

Other Identifiers

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VRortoTrzebnica

Identifier Type: -

Identifier Source: org_study_id