Virtual Reality in Orthopedic Rehabilitation

Sponsor

Joanna Szczepańska-Gieracha (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06002139

Collaborator

Wroclaw Medical University (Other), Wroclaw University of Health and Sport Sciences (Other), Jan Dlugosz University in Czestochowa (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Arthropathy Anxiety Stress	Behavioral: Immersive Virtual Reality Therapy Behavioral: Conventional rehabilitation	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Does Immersive Virtual Reality Therapy Support Orthopedic Rehabilitation? A Randomized-Controlled Trial

Actual Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Immersive Virtual Reality Therapy Conventional orthopedic rehabilitation supplemented by VR therapy	Behavioral: Immersive Virtual Reality 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. Behavioral: Conventional rehabilitation 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.
Active Comparator: Conventional rehabilitation Conventional orthopedic rehabilitation	Behavioral: Conventional rehabilitation 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.

Arm

Intervention/Treatment

Experimental: Immersive Virtual Reality Therapy

Conventional orthopedic rehabilitation supplemented by VR therapy

Behavioral: Immersive Virtual Reality 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.

Behavioral: Conventional rehabilitation

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.

Active Comparator: Conventional rehabilitation

Conventional orthopedic rehabilitation

Behavioral: Conventional rehabilitation

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Generalized Self-Efficacy Scale (GSES) [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 GSES will be applied at the beginning and after four weeks of treatment.
Barthel Index (BI) [15 minutes]
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) [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 RMA-GF will be administered at the beginning and after four weeks of treatment.
Tinetti's Short Scale [15 minutes]
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) [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.
Perception of Stress Questionnaire (PSQ) [20 minutes]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Hedwig of Silesia Hospital in Trzebnica	Trzebnica	Lower Silesia	Poland	55-100

Sponsors and Collaborators

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

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