Antigravity Treadmill Rehabilitation After Lower Limb Arthroplasty in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Western Ontario and McMaster Universities Osteoarthritis Index
研究概览
简要总结
The study aims to evaluate the efficacy of antigravity treadmill training and body weight-supported treadmill training in the rehabilitation of elderly patients (60-75 years) following hip or knee arthroplasty.
详细描述
This randomized controlled trial will recruit 60 patients aged 60-75 years, within 3 months after total hip or knee arthroplasty, admitted to the Rehabilitation Unit of St. Jadwiga Hospital in Trzebnica. Participants will be randomly assigned to one of three groups: (i) body weight-supported treadmill group (n=20), (ii) antigravity treadmill group (n=20), or (iii) control group receiving conventional gait training (n=20). All patients will receive comprehensive daily therapy for 6 weeks, including kinesitherapy, ergotherapy, and physical therapy procedures under professional supervision.
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 75 Years（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
- •history of consciousness disturbances, psychotic disorders, bipolar disorder, or other severe psychiatric illnesses
- •functional status preventing independent ambulation (wheelchair-bound or bedridden patients; orthopedic devices such as crutches or walker allowed)
- •refusal to participate in the study at any stage
结局指标
主要结局
Western Ontario and McMaster Universities Osteoarthritis Index
时间窗: Baseline and after 6 weeks of intervention
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a 24-item questionnaire used to assess pain, stiffness, and physical function in patients with hip or knee osteoarthritis. Each item is scored on a scale from 0 to 4, with higher scores indicating greater severity. The total score is calculated as the sum of three subscales: pain (0-20 points), stiffness (0-8 points), and physical function (0-68 points), yielding a global score range of 0 to 96. Higher scores reflect worse joint function, greater pain, and more severe stiffness.
次要结局
- Berg Balance Scale(Baseline and after 6 weeks of intervention)
- Patient Health Questionnaire(Baseline and after 6 weeks of intervention)
- Perceived Stress Scale(Baseline and after 6 weeks of intervention)
- Falls Efficacy Scale-International(Baseline and after 6 weeks of intervention)
- Step Length(Baseline and after 6 weeks of intervention)
- Step Time(Baseline and after 6 weeks of intervention)
- Stance Phase Duration(Baseline and after 6 weeks of intervention)
- Swing Phase Duration(Baseline and after 6 weeks of intervention)
- Vertical Load(Baseline and after 6 weeks of intervention)
研究者
Błażej Cieślik
Professor
Wroclaw University of Health and Sport Sciences