- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06002139
Virtual Reality in Orthopedic Rehabilitation
Does Immersive Virtual Reality Therapy Support Orthopedic Rehabilitation? A Randomized-Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Lower Silesia
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Trzebnica, Lower Silesia, Poland, 55-100
- St. Hedwig of Silesia Hospital in Trzebnica
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Immersive Virtual Reality Therapy
Conventional orthopedic rehabilitation supplemented by VR 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. Four weeks of conventional rehabilitation including:
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Active Comparator: Conventional rehabilitation
Conventional orthopedic rehabilitation
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Four weeks of conventional rehabilitation including:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital Anxiety and Depression Scale
Time Frame: 15 minutes
|
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
Time Frame: 10 minutes
|
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.
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10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Generalized Self-Efficacy Scale
Time Frame: 15 minutes
|
The Generalized Self-Efficacy Scale (GSES) is a ten-item psychometric scale that is designed to assess optimistic self-beliefs to cope with a variety of difficult demands in life.
The scale measures the belief in one's competence to cope with a broad range of stressful or challenging demands.
The score ranges from 10 to 40, with a higher score indicating a greater sense of self-efficacy.
The Generalized Self-Efficacy Scale will be applied at the beginning and after four weeks of treatment.
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15 minutes
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Barthel Index
Time Frame: 15 minutes
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The Barthel Index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL).
Each performance item is rated on this scale with a given number of points assigned to each level or ranking.
It uses ten variables describing activities of daily living and mobility.
Scores range from 0 to 100, with higher scores associated with a greater likelihood of being able to live at home with a degree of independence following discharge from the hospital.
The the Barthel Index will be administered at the beginning and after four weeks of treatment.
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15 minutes
|
Rivermead Mobility Index
Time Frame: 15 minutes
|
The Rivermead Mobility Index (RMI) was developed from the Rivermead Motor Assessment Gross Function subscale as a means to quantify mobility disability.
It is composed of 14 items representing different mobility tasks, ranging from turning over in bed to running.
Each item is scored as 'unable' (0) or 'able' (1), leading to a maximum score of 14, which indicates full mobility.
The Rivermead Mobility Index will be administered at the beginning and after four weeks of treatment.
|
15 minutes
|
Tinetti's Short Scale
Time Frame: 15 minutes
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Tinetti's Short Scale for fall risk assessment is a shortened version of Performance-Oriented Mobility Assessment (POMA).
It is easily administered test that measures a patient's gait and balance.
The test is scored on the patient's ability to perform following tasks: Change from sitting to standing, Immobilization in standing position for 5 seconds, Passing 3 meters, Turn of 180 degrees, Keeping a sitting position.
Each task is rated in 3-point Likert scale.
The scales rage from 0-15, with the higher scores indicate better functional mobility.
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15 minutes
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Short Physical Performance Battery
Time Frame: 15 minutes
|
The Short Physical Performance Battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests.
It provides a composite score ranging from 0 (worst performance) to 12 (best performance), offering a global assessment of physical functioning in older individuals.
The SPPB will be administered at the beginning and after four weeks of treatment.
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15 minutes
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Perception of Stress Questionnaire
Time Frame: 20 minutes
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The Perception of Stress Questionnaire (PSQ) was created by Plopa and Makarowski.
It is a 27-item scale scoring from 1 to 5 points for each item, where 21 items examine the level of stress in the areas of emotional tension, external stress and intrapsychic stress, and six items refer to the lie scale.
The global scoring for the perception of stress ranges from 21 to 105, with a cut-off point of 60 for an elevated level of perceived stress.
Higher scores indicate higher stress perception.
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20 minutes
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Justyna Mazurek, PhD, Wroclaw Medical University
- Study Chair: Błażej Cieślik, PhD, Jan Dlugosz University in Czestochowa, Poland
- Principal Investigator: Justyna Mazurek, RhD, Wroclaw Medical University
- Study Director: Joanna Szczepańska-Gieracha, Professor, Wrocław University of Health and Sport Sciences
- Study Director: Robert Gajda, PhD, Gajda-Med District Hospital in Pułtusk
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VRortoTrzebnica
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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