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Clinical Trials/NCT06002139
NCT06002139
Completed
Not Applicable

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

Joanna Szczepańska-Gieracha1 site in 1 country68 target enrollmentJune 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arthropathy
Sponsor
Joanna Szczepańska-Gieracha
Enrollment
68
Locations
1
Primary Endpoint
Perceived Stress Scale
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2023
End Date
October 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Joanna Szczepańska-Gieracha
Responsible Party
Sponsor Investigator
Principal Investigator

Joanna Szczepańska-Gieracha

Professor

Wroclaw University of Health and Sport Sciences

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

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Rivermead Mobility Index(15 minutes)
  • Generalized Self-Efficacy Scale(15 minutes)
  • Barthel Index(15 minutes)
  • Perception of Stress Questionnaire(20 minutes)
  • Tinetti's Short Scale(15 minutes)
  • Short Physical Performance Battery(15 minutes)

Study Sites (1)

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