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临床试验/NCT03100890
NCT03100890已完成不适用

In-home Versus Hospital Preoperative Training for Patients Undergoing Total Knee Replacement

University of Valencia2 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2017年4月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
67
试验地点
2
主要终点
Knee injury and Osteoarthritis Outcome Score (KOOS)

研究概览

简要总结

In this work the importance of the potentiation and recovery of the balance with a physiotherapeutic intervention that begins in the early preoperative phase is compared with the conventional postoperative rehabilitation. The objective is to evaluate the influence of a muscle enhancement protocol in which a specific work of balance is included, with the physical benefits that this entails for the evolution of the patient. It also seeks to verify if the teaching and recommendation of exercises at home as preparation and conditioning for the intervention of ATR is effective, and to what extent, compared to a guided training in the hospital.

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 (Investigator, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects with severe knee osteoarthritis that have not been operated before of total knee replacement.
  • The score in Berg scale must be greater than
  • The score of the Mini-Mental State Examination must be equal or greater than
  • Once the informed consent is read and explained, patients must accept and agree to participate in the study.

排除标准

  • Post-surgical infection of the operated knee.
  • Pathology of central origin (i.e. cerebellar) that could interfere with balance or strength
  • Vestibular pathology that could interfere with balance

结局指标

主要结局

Knee injury and Osteoarthritis Outcome Score (KOOS)

时间窗: change from baseline to the week before surgery, 2 and 6 weeks after surgery

Self-reported functionality assessment

Berg Balance Scale (BBS)

时间窗: change from baseline to the week before surgery, 2 and 6 weeks after surgery

Overall state of balance. 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

  • Quadriceps Strength(change from baseline to the week before surgery, 2 and 6 weeks after surgery)
  • Timed Up and Go Test (TUG)(change from baseline to the week before surgery, 2 and 6 weeks after surgery)
  • Knee Range of Mobility (ROM)(change from baseline to the week before surgery, 2 and 6 weeks after surgery)
  • Euro Quality of Life 5 Dimension(change from baseline to the week before surgery, 2 and 6 weeks after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jose María Blasco Igual

PhD

University of Valencia

研究点 (2)

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