Biomechanics of Gait Pattern Adaptation in Patients After Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from Baseline in Gait Patterns at 6-8 weeks, 5-6 months and 11-12 months
研究概览
简要总结
This study aimed to discover the biomechanics of gait pattern adaptation in patients after a total knee replacement.
The first hypothesis of the project was that center-of-pressure manipulation at the foot during dynamic loading is capable of changing the forces, torques and muscle activation patterns of the lower limb.
The second hypothesis of the project was that patient-specific center-of-pressure manipulation at the foot combined with repetitive perturbation training over time will improve neuromuscular function, barefoot gait patterns, muscle activation patterns, pain, quality of life and energy consumption in patients after a total knee replacement.
详细描述
This study is a randomized prospective controlled study of patients after total knee arthroplasty. Patients will be recruited to the study and divided randomly into an experimental and control group. Both groups will match in terms of gender, age, pathology and clinical assessment. In addition to the intervention of the present study, all patients, whether in the experimental or control group, will carry out the usual physical therapy exercises for total knee arthroplasty as directed by their physician. The patients will be recruited and evaluated prior to surgery and for a follow-up period after surgery.
After surgery, patients in the experimental group will be fitted with a customized biomechanical device worn on the feet (Apos System, Apos - Sports and Medical Technologies Ltd. Hertzlia, Israel). The device is calibrated personally to each patient. By calibrating the device, the center-of-pressure of the foot can be manipulated during all phases of the gait cycle. The device is capable of inducing controlled perturbation during gait. The immediate effects of the device will be evaluated using center-of-pressure measurements, three-dimensional gait analyses and surface electromyography. The patients are instructed to walk with the device according to a therapy protocol (AposTherapy). Patients will be evaluated for changes in gait via three-dimensional gait analyses, muscle activation pattern changes via surface electromyography, pain, quality of life and energy consumption.
The patients in the control group will carry out the same walking exercises as the experimental group, but without the biomechanical intervention device (placebo walking shoe). The patients will be evaluated with the same tools over time as with the experimental group.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for first total knee arthroplasty due to end-stage knee osteoarthritis
- •Ambulatory and active patients that can participate in gait analysis
排除标准
- •Prior joint surgery of either lower extremity, with the exception of arthroscopy
- •Unsteady gait
- •Back pain
- •Neurological, pulmonary or cardiovascular pathologies or risks that may affect long-term performance
- •Inability to understand or comply with the treatment protocol
结局指标
主要结局
Change from Baseline in Gait Patterns at 6-8 weeks, 5-6 months and 11-12 months
时间窗: An average of 2 weeks prior to surgery and an average of 6-8 weeks, 5-6 months and 11-12 months after surgery
Three-dimensional gait analysis of spatiotemporal, kinetic and kinematic parameters. Surface electromyographic analysis of muscle activation patterns. Center of pressure measurements and function tests.
次要结局
- Change from Baseline in Pain, Function and Quality of Life Assessments at 6-8 weeks, 5-6 months and 11-12 months(An average of 2 weeks prior to surgery and an average of 6-8 weeks, 5-6 months and 11-12 months after surgery)