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ArthropathyNCT06002139

Virtual Reality in Orthopedic Rehabilitation

A study testing Immersive Virtual Reality Therapy and Conventional rehabilitation in people with Arthropathy and Anxiety, run by Joanna Szczepańska-Gieracha at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Arthropathy, Anxiety, Stress
What is being tested?
Immersive Virtual Reality Therapy and Conventional rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 sitePoland
Study dates
1 Jun 2023to 1 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Individuals who have recently undergone hip or knee joint arthroplasty surgeries aged 60 years and above.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • St. Hedwig of Silesia Hospital in Trzebnica

    Trzebnica, Lower Silesian Voivodeship, 55-100

Other trials in Poland

About this study

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

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.

Read the 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.

Being tested
Immersive Virtual Reality Therapy, Conventional rehabilitation
Keywords
arthroplasty, stress, fall risk, depression, anxiety, self-efficacy
Medical subject headings
Joint Diseases, Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Immersive Virtual Reality TherapyBehavioural

    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.

  • Conventional rehabilitationBehavioural

    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.
Study groups in NCT06002139
Study groupRoleWhat they receive
Immersive Virtual Reality TherapyExperimentalConventional orthopedic rehabilitation supplemented by VR therapy
Receives: Behavioral: Immersive Virtual Reality Therapy; Behavioral: Conventional rehabilitation
Conventional rehabilitationActive comparatorConventional orthopedic rehabilitation
Receives: Behavioral: Conventional rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 15 minutes

  2. 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.

    Measured: 10 minutes

Secondary outcomes (6)

  1. Generalized Self-Efficacy Scale

    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.

    Measured: 15 minutes

  2. Barthel Index

    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.

    Measured: 15 minutes

  3. Rivermead Mobility Index

    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.

    Measured: 15 minutes

  4. 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. The scales rage from 0-15, with the higher scores indicate better functional mobility.

    Measured: 15 minutes

  5. Short Physical Performance Battery

    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.

    Measured: 15 minutes

  6. Perception of Stress Questionnaire

    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.

    Measured: 20 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2023
  2. Study start1 Jun 2023
  3. Primary completion15 Sep 2023
  4. Study completion1 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06002139
Sponsor's protocol ID
VRortoTrzebnica
Status last verified
Dec 2023
First submitted
14 Aug 2023
Last updated
12 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 32951730

  • 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.

    PubMed 33073855

  • 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.

    PubMed 36447623

  • 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.

    PubMed 32741792

  • 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.

    PubMed 36613047

  • 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.

    PubMed 33577375

  • 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.

    PubMed 37360811

  • 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.

    PubMed 33477733

Questions about this trial

What is this clinical trial studying?

A study testing Immersive Virtual Reality Therapy and Conventional rehabilitation in people with Arthropathy and Anxiety, run by Joanna Szczepańska-Gieracha at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hospital Anxiety and Depression Scale (time frame: 15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06002139, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.

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