Does Immersive Virtual Reality Therapy Support Orthopedic Rehabilitation? A Randomized-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Perceived Stress Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals who have recently undergone hip or knee joint arthroplasty surgeries aged 60 years and above.
排除标准
- •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
结局指标
主要结局
Perceived Stress Scale
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Joanna Szczepańska-Gieracha
Professor
Wroclaw University of Health and Sport Sciences