Clinical trial NCT06002139: Virtual Reality in Orthopedic Rehabilitation
Official title: Does Immersive Virtual Reality Therapy Support Orthopedic Rehabilitation? A Randomized-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthropathy
Anxiety
Stress
Keywords: arthroplasty
stress
fall risk
depression
anxiety
self-efficacy
Lead sponsor: Wroclaw University of Health and Sport Sciences
Sponsor class: OTHER
Collaborators: name: Wroclaw Medical University
name: Wroclaw University of Health and Sport Sciences
name: Jan Dlugosz University in Czestochowa
First posted: 2023-08-21
Enrollment: 68
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hospital Anxiety and Depression Scale
timeFrame: 15 minutes
measure: Perceived Stress Scale
timeFrame: 10 minutes
Secondary outcomes:
measure: Generalized Self-Efficacy Scale
timeFrame: 15 minutes
measure: Barthel Index
timeFrame: 15 minutes
measure: Rivermead Mobility Index
timeFrame: 15 minutes
measure: Tinetti's Short Scale
timeFrame: 15 minutes
measure: Short Physical Performance Battery
timeFrame: 15 minutes
measure: Perception of Stress Questionnaire
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Trzebnica
country: Poland
facility: St. Hedwig of Silesia Hospital in Trzebnica
state: Lower Silesia
Study officials:
affiliation: Wroclaw Medical University
name: Justyna Mazurek, PhD
role: STUDY_CHAIR
affiliation: Jan Dlugosz University in Czestochowa, Poland
name: Błażej Cieślik, PhD
role: STUDY_CHAIR
affiliation: Wroclaw Medical University
name: Justyna Mazurek, RhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wrocław University of Health and Sport Sciences
name: Joanna Szczepańska-Gieracha, Professor
role: STUDY_DIRECTOR
affiliation: Gajda-Med District Hospital in Pułtusk
name: Robert Gajda, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.