Functional Recovery Evaluation Following Total Hip Arthroplasty And Early Home Rehabilitation Program With A Virtual Reality Based Rehabilitation System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)
研究概览
简要总结
Total hip replacement (THR) is one of the most common interventions in orthopedic surgery.
Rehabilitation is essential for maximizing the effectiveness of the surgery. Tele-rehabilitation programs after orthopedic surgery have proven their effectiveness, validity and cost-efficacy.
It seems of interest to test the potential advantages of early virtual reality based rehabilitation programs after total hip arthroplasty compared to standard care. The aim of the study is to evaluate the functional recovery following total hip arthroplasty and home telerehabilitation programs with a virtual reality based system.
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
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •males and females from 50 to 70 years old
- •patients undergoing total hip arthroplasty with Anterior Minimally Invasive Surgery (AMIS)
- •Body Mass Index ≤ 31
- •Schooling: Lower secondary certificate
- •Home internet connection
- •Caregiver presence
- •Domiciled in the conurbation of Milan
- •Written informed consent and consent to all phases of the study
排除标准
- •congenital or post traumatic morphological abnormalities
- •presence of neurological conditions or cancer
- •presence of implanted devices subjected to electromagnetic interference
- •informed refusal
- •Ongoing anticoagulant or immunosuppressive therapies before surgery
- •Self reported pregnancy
结局指标
主要结局
Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)
时间窗: 15 ± 1 days after the surgery (T3)
the HOOS JR scale scores ranges from 0 to 100 where 0 represents total hip disability and 100 represents perfect hip health
次要结局
- Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement (HOOS JR)(baseline (before surgery (T0)), 4 ± 1 days after the surgery (T1), 7 ± 2 days after the surgery (T2))
- BARTHEL INDEX (BI)(baseline (before surgery (T0)), 4 ± 1 days after the surgery (T1), 15 ± 1 days after the surgery (T3))
- Global Perceived Effect (GPE)(15 ± 1 days after the surgery (T3))
- Functional Independence Measure (FIM)(baseline (before surgery (T0)), 4 ± 1 days after the surgery (T1), 15 ± 1 days after the surgery (T3))