Immersive VR for Female Orthopaedic Rehabilitation

NCT06506760 | Completed

• 1 other identifier: VRortov2
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hip Arthropathy

Keywords

virtual reality; arthroplasty; women; depression

Outcome Measures

Primary Outcomes (1)

• Hospital Anxiety and Depression Scale

  The Hospital Anxiety and Depression Scale (HADS) is a fourteen-item scale scoring from 0 to 3 for each item. The first seven items relate to anxiety (HADS-A), and the remaining seven items relate to depression (HADS-D). The global scoring ranges from 0 to 42 with a cut-off point of 8/21 for anxiety and 8/21 for depression. The higher the score, the greater anxiety or depression symptoms.

  Baseline and 4 weeks

Secondary Outcomes (7)

• Perceived Stress Scale

  Baseline and 4 weeks

• Generalized Self-Efficacy Scale

  Baseline and 4 weeks

• Barthel Index

  Baseline and 4 weeks

• Rivermead Mobility Index

  Baseline and 4 weeks

• Tinetti's Short Scale

  Baseline and 4 weeks

Study Arms (2)

Immersive Virtual Reality Therapy

EXPERIMENTAL

Conventional orthopedic rehabilitation supplemented by VR therapy

Behavioral: Immersive Virtual Reality Therapy

Conventional rehabilitation

ACTIVE COMPARATOR

Conventional orthopedic rehabilitation

Behavioral: Immersive Virtual Reality Therapy; Behavioral: Conventional rehabilitation

Interventions

Immersive Virtual Reality Therapy 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; Immersive Virtual Reality Therapy

Conventional rehabilitation 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

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female individuals who have recently undergone hip joint arthroplasty surgeries aged 60 years and above.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wroclaw University of Health and Sport Sciences: lead
• Wroclaw Medical University: collaborator
• Jan Dlugosz University in Czestochowa: collaborator

Study Sites (1)

St. Hedwig of Silesia Hospital

Trzebnica, Lower Silesian Voivodeship, 55-100, Poland

Location

Related Publications (5)

• 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.

  PMID: 32951730 BACKGROUND

• 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.

  PMID: 32741792 BACKGROUND

• 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.

  PMID: 33577375 BACKGROUND

• 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.

  PMID: 38168468 BACKGROUND

• 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.

  PMID: 38137750 BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Justyna Mazurek, PhD

  Wroclaw Medical University

  PRINCIPAL INVESTIGATOR

• Joanna Szczepańska-Gieracha, Professor

  Wrocław University of Health and Sport Sciences

  STUDY CHAIR

• Robert Gajda, PhD

  Gajda-Med District Hospital in Pułtusk

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 17, 2024
• Study Start: January 11, 2024
• Primary Completion: August 15, 2024
• Study Completion: August 30, 2024
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)