Immersive VR for Female Orthopaedic Rehabilitation

NCT ID: NCT06506760

Last Updated: 2025-03-24

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-11

Study Completion Date

2024-08-30

Brief Summary

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This study compares the effects of cardiological rehabilitation enhanced with virtual reality (VR) versus conventional rehabilitation methods. It assesses the impact on both psychological parameters (including depression, stress, anxiety, and kinesiophobia) and physiological and functional parameters of cardiology patients. The aim is to analyze the efficacy and benefits of VR-supported rehabilitation in improving patients' mental and physical health compared to traditional methods.

Detailed Description

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The study will involve elderly female patients aged 60 and above who present sequentially at the Rehabilitation Department of St. Hedwig of Silesia Hospital in Trzebnica (Poland) within three months following hip joint arthroplasty surgery. Participants will be randomly assigned to one of two groups: Group A, the Virtual Reality Group, will receive 8 therapy sessions, with two sessions per week; Group B, the Control Group, will undergo conventional rehabilitation.

Conditions

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Hip Arthropathy

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

Conventional orthopedic rehabilitation

Group Type ACTIVE_COMPARATOR

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.

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

* Female individuals who have recently undergone hip 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

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Wroclaw Medical University

OTHER

Sponsor Role collaborator

Jan Dlugosz University in Czestochowa

OTHER

Sponsor Role collaborator

Wroclaw University of Health and Sport Sciences

OTHER

Sponsor Role lead

Responsible Party

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Joanna Szczepańska-Gieracha

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Justyna Mazurek, PhD

Role: PRINCIPAL_INVESTIGATOR

Wroclaw Medical University

Joanna Szczepańska-Gieracha, Professor

Role: STUDY_CHAIR

Wrocław University of Health and Sport Sciences

Robert Gajda, PhD

Role: STUDY_CHAIR

Gajda-Med District Hospital in Pułtusk

Locations

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St. Hedwig of Silesia Hospital

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)

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)

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)

Wrzeciono A, Cieslik B, Kiper P, Szczepanska-Gieracha J, Gajda R. Exploratory analysis of the effectiveness of virtual reality in cardiovascular rehabilitation. Sci Rep. 2024 Jan 2;14(1):281. doi: 10.1038/s41598-023-50788-9.

Reference Type BACKGROUND
PMID: 38168468 (View on PubMed)

Mazurek J, Cieslik B, Wrzeciono A, Gajda R, Szczepanska-Gieracha J. Immersive Virtual Reality Therapy Is Supportive for Orthopedic Rehabilitation among the Elderly: A Randomized Controlled Trial. J Clin Med. 2023 Dec 14;12(24):7681. doi: 10.3390/jcm12247681.

Reference Type BACKGROUND
PMID: 38137750 (View on PubMed)

Other Identifiers

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VRortov2

Identifier Type: -

Identifier Source: org_study_id

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