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临床试验/NCT03365427
NCT03365427Unknown不适用

Effect of Applications on Smart Phone on Post-operative Rehabilitation of Total Knee Arthroplasty: A Randomized Clinical Trail

Peking University People's Hospital0 个研究点目标入组 200 人开始时间: 2018年1月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
200
主要终点
The change of knee pain

研究概览

简要总结

This study is designed to estimate the effect of an application on rehabilitation for osteoarthritis patients after total knee arthroplasty.

详细描述

Apart from surgical technique, the outcome of total knee arthroplasty (TKA) also largely depend on adequate rehabilitation and subsequent functional recovery after surgery.Rehabilitation affects or even determines various performance of post-operative knee, including knee range-of-motion (ROM), muscle strength, functional independence, all of which subsequently affect patients' quality of life. Conventional way of rehabilitation is exercise therapy, which rely on guidance of therapists and the self-efficacy of patients.

An application (APP) on smart phone was designed for people received TKA to play the role of guider and help improving patients' self-efficacy. This is a single-centre randomized clinical trial, with an anticipation of 200 patients with knee osteoarthritis enrolled, who will be randomly assigned into experiment group or control group. The patients in the experiment group will be introduced to this APP and requested to use it regularly, while the patients in the control group will receive pure conventional rehabilitation. Primary outcome includes Visual analogue scale (VAS) of pain, knee society score (KSS), ROM, ability of daily living (ADL) before operation and at 2 weeks and 6 weeks after surgery. All potential covariates of those two groups, such as age, sex, and pre-operative kellgren-lawrence scores would be matched by completely randomize.

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

  • •Diagnosed as knee osteoarthritis with bearing X-ray
  • •Education level of middle school and above
  • •Prepared to take single-knee primary TKA

排除标准

  • •Severe varus/valgus (over 10 degree) of affected knee before surgery
  • •Stiffness of affected knee before surgery

研究组 & 干预措施

Convention Group

No Intervention

People in this arm receive exactly the same treatment and lessons on post-operative rehabilitation except the reach of the APP.

Application Group

Experimental

People in this arm will be introduced to an APP on smart phone, and receive lessons on how to use it on their own phones. The APP will be installed and prepare to use before surgery. People will be asked and monitored on-line to regularly use the APP.

干预措施: APP (Other)

结局指标

主要结局

The change of knee pain

时间窗: before operation, 2 and 6 weeks after operation

To use the Visual analogue scale (VAS) to estimate the pain of the affected knee. Its score ranges from 0 to 10, and higher score means more severe pain.

次要结局

  • The change of the range of motion of affected knee(before operation, 2 and 6 weeks after operation)
  • The change of the symptoms of the affected knee(before operation, 2 and 6 weeks after operation)

研究者

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

Lin Chutong

The clinical professor of arthritis clinic and research center

Peking University People's Hospital

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