Early Domestic Rehabilitation Using Virtual Reality for Patients With Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- The International Knee Documentation Committee (IKDC) Subjective Knee Form
研究概览
简要总结
The purpose of this study is to ascertain whether 4 weeks of daily virtual-reality-based rehabilitation at home improves disability in the early stages of recovery from anterior cruciate ligament reconstruction surgery compared with standard care.
详细描述
After being informed about the study and potential risks and benefits, patients giving written informed consent will be randomized to one of two groups in a 1:1 ratio. The treatment group will perform daily a 20-minute rehabilitation session in virtual reality, in which they will observe their virtual body performing a series of exercises they would otherwise be unable to perform in real life. Both groups will also undergo the standard rehabilitation protocol. The investigators will assess for differences between groups in self-reported disability, knee range of motion, and quadriceps strength at baseline, 4 weeks, 12 weeks and 9 months.
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
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-40 (either sex)
- •Post-operative anterior cruciate ligament reconstruction (autograft), either bone-patellar tendon-bone graft or semitendinosus (hamstring) graft
排除标准
- •Patients with significant cognitive deficit (MEC<24).
- •Patients with epilepsy or severe vision problems
- •Pregnant patients
- •Previous surgery on the reconstructed knee, excluding arthroscopy
- •Previous anterior cruciate ligament reconstruction on either knee
- •Sustained concurrent injury to the contralateral knee
- •Concomitant collateral ligament and/or meniscal repair
- •Presence of symptomatic tibiofemoral osteoarthritis
结局指标
主要结局
The International Knee Documentation Committee (IKDC) Subjective Knee Form
时间窗: 9 months
Patient-completed tool, which contains sections on knee symptoms/pain, function, and sports activities. Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
次要结局
- Time taken to return to sporting activity(9 months)
- Isometric quadriceps strength(9 months)
- Kinesiophobia(9 months)
- Knee extension active range of motion(9 months)
研究者
Prof. Maria V. Sanchez-Vives
Professor
Institut d'Investigacions Biomèdiques August Pi i Sunyer