search
Back to results

Virtual Reality in Orthopedic Rehabilitation

Primary Purpose

Arthropathy, Anxiety, Stress

Status
Active
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Immersive Virtual Reality Therapy
Conventional rehabilitation
Sponsored by
Joanna Szczepańska-Gieracha
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthropathy focused on measuring arthroplasty, stress, fall risk, depression, anxiety, self-efficacy

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Hedwig of Silesia Hospital in Trzebnica

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immersive Virtual Reality Therapy

Conventional rehabilitation

Arm Description

Conventional orthopedic rehabilitation supplemented by VR therapy

Conventional orthopedic rehabilitation

Outcomes

Primary Outcome Measures

Hospital Anxiety and Depression Scale (HADS)
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.
Perceived Stress Scale (PSS-10)
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 PSS-10 will be administered at the beginning and after four weeks of treatment.

Secondary Outcome Measures

Generalized Self-Efficacy Scale (GSES)
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 GSES will be applied at the beginning and after four weeks of treatment.
Barthel Index (BI)
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 ADL and mobility. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from the hospital. The BI will be administered at the beginning and after four weeks of treatment.
Rivermead Mobility Index (RMI)
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 RMA-GF will be administered at the beginning and after four weeks of treatment.
Tinetti's Short Scale
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.
Short Physical Performance Battery (SPPB)
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.
Perception of Stress Questionnaire (PSQ)
The 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.

Full Information

First Posted
August 14, 2023
Last Updated
August 14, 2023
Sponsor
Joanna Szczepańska-Gieracha
Collaborators
Wroclaw Medical University, Wroclaw University of Health and Sport Sciences, Jan Dlugosz University in Czestochowa
search

1. Study Identification

Unique Protocol Identification Number
NCT06002139
Brief Title
Virtual Reality in Orthopedic Rehabilitation
Official Title
Does Immersive Virtual Reality Therapy Support Orthopedic Rehabilitation? A Randomized-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Joanna Szczepańska-Gieracha
Collaborators
Wroclaw Medical University, Wroclaw University of Health and Sport Sciences, Jan Dlugosz University in Czestochowa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. We 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthropathy, Anxiety, Stress
Keywords
arthroplasty, stress, fall risk, depression, anxiety, self-efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immersive Virtual Reality Therapy
Arm Type
Experimental
Arm Description
Conventional orthopedic rehabilitation supplemented by VR therapy
Arm Title
Conventional rehabilitation
Arm Type
Active Comparator
Arm Description
Conventional orthopedic rehabilitation
Intervention Type
Behavioral
Intervention Name(s)
Immersive Virtual Reality Therapy
Intervention Description
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
Intervention Name(s)
Conventional rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
15 minutes
Title
Perceived Stress Scale (PSS-10)
Description
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 PSS-10 will be administered at the beginning and after four weeks of treatment.
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Generalized Self-Efficacy Scale (GSES)
Description
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 GSES will be applied at the beginning and after four weeks of treatment.
Time Frame
15 minutes
Title
Barthel Index (BI)
Description
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 ADL and mobility. A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from the hospital. The BI will be administered at the beginning and after four weeks of treatment.
Time Frame
15 minutes
Title
Rivermead Mobility Index (RMI)
Description
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 RMA-GF will be administered at the beginning and after four weeks of treatment.
Time Frame
15 minutes
Title
Tinetti's Short Scale
Description
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.
Time Frame
15 minutes
Title
Short Physical Performance Battery (SPPB)
Description
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.
Time Frame
15 minutes
Title
Perception of Stress Questionnaire (PSQ)
Description
The 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.
Time Frame
20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justyna Mazurek, PhD
Organizational Affiliation
Wroclaw Medical University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Błażej Cieślik, PhD
Organizational Affiliation
Jan Dlugosz University in Czestochowa, Poland
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Justyna Mazurek, RhD
Organizational Affiliation
Wroclaw Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joanna Szczepańska-Gieracha, Professor
Organizational Affiliation
Wrocław University of Health and Sport Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Robert Gajda, PhD
Organizational Affiliation
Gajda-Med District Hospital in Pułtusk
Official's Role
Study Director
Facility Information:
Facility Name
St. Hedwig of Silesia Hospital in Trzebnica
City
Trzebnica
State/Province
Lower Silesia
ZIP/Postal Code
55-100
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32951730
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.
Results Reference
background
PubMed Identifier
33073855
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.
Results Reference
background
PubMed Identifier
36447623
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.
Results Reference
background
PubMed Identifier
32741792
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.
Results Reference
background
PubMed Identifier
36613047
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.
Results Reference
background
PubMed Identifier
33577375
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.
Results Reference
background
PubMed Identifier
37360811
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.
Results Reference
background
PubMed Identifier
33477733
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.
Results Reference
background

Learn more about this trial

Virtual Reality in Orthopedic Rehabilitation

We'll reach out to this number within 24 hrs