Virtual Reality in Orthopedic Rehabilitation

NCT06002139 | Completed

• 1 other identifier: VRortoTrzebnica
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arthropathy; Anxiety; Stress

Keywords

arthroplasty; stress; fall risk; depression; anxiety; self-efficacy

Outcome Measures

Primary Outcomes (2)

• 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.

  15 minutes

• Perceived Stress Scale

  The Perceived Stress Scale (PSS-10) is a ten-item scale that assesses the level of stress perceived by an individual in the last month. The questions are general in nature and fairly free of content specific to any subpopulation group. The items are designed to tap into how unpredictable, uncontrollable, and overloaded respondents find their lives to be. The scores range from 0 to 40, with higher scores indicating higher perceived stress. The Perceived Stress Scale will be administered at the beginning and after four weeks of treatment.

  10 minutes

Secondary Outcomes (6)

• Generalized Self-Efficacy Scale

  15 minutes

• Barthel Index

  15 minutes

• Rivermead Mobility Index

  15 minutes

• Tinetti's Short Scale

  15 minutes

• Short Physical Performance Battery

  15 minutes

Study Arms (2)

Immersive Virtual Reality Therapy

EXPERIMENTAL

Conventional orthopedic rehabilitation supplemented by VR therapy

Behavioral: Immersive Virtual Reality Therapy; Behavioral: Conventional rehabilitation

Conventional rehabilitation

ACTIVE COMPARATOR

Conventional orthopedic rehabilitation

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.

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; Immersive Virtual Reality Therapy

Eligibility Criteria

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

You may qualify if:

• Individuals who have recently undergone hip or knee 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

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

Study Sites (1)

St. Hedwig of Silesia Hospital in Trzebnica

Trzebnica, Lower Silesian Voivodeship, 55-100, Poland

Location

Related Publications (8)

• 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

• 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.

  PMID: 33073855 BACKGROUND

• 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.

  PMID: 36447623 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

• 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.

  PMID: 36613047 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

• 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.

  PMID: 37360811 BACKGROUND

• 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.

  PMID: 33477733 BACKGROUND

MeSH Terms

Conditions

Joint Diseases; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Justyna Mazurek, PhD

  Wroclaw Medical University

  STUDY CHAIR

• Błażej Cieślik, PhD

  Jan Dlugosz University in Czestochowa, Poland

  STUDY CHAIR

• Justyna Mazurek, RhD

  Wroclaw Medical University

  PRINCIPAL INVESTIGATOR

• Joanna Szczepańska-Gieracha, Professor

  Wrocław University of Health and Sport Sciences

  STUDY DIRECTOR

• Robert Gajda, PhD

  Gajda-Med District Hospital in Pułtusk

  STUDY DIRECTOR

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: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 21, 2023
• Study Start: June 1, 2023
• Primary Completion: September 15, 2023
• Study Completion: October 1, 2023
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)