Valoración de la Puesta en Marcha en Artroplastias Totales de Rodilla Mediante un Trabajo Postural en Plataforma Dinamometrica
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 主要终点
- Berg Balance Scale
研究概览
简要总结
Knee osteoarthritis produces degeneration and joint wear that greatly affects the patient's proprioceptive system increasing instability. After total knee arthroplasty intervention, it is recommended that the patient performs a rehabilitation procedure to minimize deficits caused by surgery. In this job it is essential to insist on the importance of recovering balance after total knee arthroplasty intervention, and assess a specifically designed protocol to restore its function. An intervention which includes a dynamometric platform as a training method was proposed. The randomized clinical trial compared a control group that performed balance exercises on parallel bars, unstable plates, ramps and stairs against an experimental group that included dynamometric platforms training as a differentiator.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 65 and
- •Subjects with knee osteoarthritis that have not been operated before.
- •Patients operated with the same total replacement prosthesis.
- •Patients operated with the same surgical procedure.
- •Time before intervention over 4 weeks.
- •Time to start rehabilitation after surgery must be less than 4 weeks.
- •The Result in Berg scale must be greater than 21, indicating a medium-low risk of falling.
- •the Result of the Mini-Mental State Examination must be equal or greater than 20, which means they do not have moderate or severe cognitive impairment.
- •Once the informed consent is read and explained, patients must accept and agree to participate in the study.
排除标准
- •Patient does no accept sign the informed consent.
- •Patient with morphological alterations hip or ankle (also knee).
- •Patient that presents knee flexion out of the range between 70 ° and -20 ° because of the risk posed to suffer a fall.
- •Patient with suspected deep vein thrombosis.
- •Patient with post-surgical infection of the operated knee.
- •Patient with psychiatric disorders: depression, anxious syndrome, etc.
- •Patient with pathology of central origin (i.e. cerebellar) that could interfere with the results of the test of balance or strength
- •Patient with vestibular pathology that could interfere with the results of the test of balance
结局指标
主要结局
Berg Balance Scale
时间窗: Change from baseline (two weeks after intervention) to after four weeks of training
Balance among older people with impairment in balance function by assessing the performance of functional tasks from the total score achieved in the 14 items test
次要结局
- Romberg Tests(Change from baseline (two weeks after intervention) to after four weeks of training)
- Knee Range of Mobility (º)(Change from baseline (two weeks after intervention) to after four weeks of training)
- Functional Reach (cm)(Change from baseline (two weeks after intervention) to after four weeks of training)
- Timed Up and Go Test (s)(Change from baseline (two weeks after intervention) to after four weeks of training)
- Kendall and Lovet scale(Change from baseline (two weeks after intervention) to after four weeks of training)
研究者
Sergio Roig Casasus
Dr.
University of Valencia