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临床试验/NCT03890848
NCT03890848Unknown不适用

Evaluation of the Effects of Home-based Functional Exercise on Patients With Anterior Cruciate Ligament Rupture Reconstruction Based on the Health Belief Model

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
110
试验地点
1
主要终点
qualified rate of knee joint activity

研究概览

简要总结

This study will evaluate the effect of home-based functional exercise on patients with anterior cruciate ligament rupture reconstruction based on the health belief model. About 360 participants will be randomly allocated into two groups. One group will randomized to receive precautions and rehabilitation progress reminders and other news by optimized WeChat applet regularly, while the other group will randomized to receive the rehabilitation exercise guidance during routine discharge.

详细描述

With the development of national fitness and sports, the incidence of anterior cruciate ligament (ACL) injuries has increased. ACL reconstruction is the best treatment for ACL injury. The success rate of surgery is high, but the patient still needs to rehabilitate after surgery, otherwise it is difficult to fully recover knee function. However, the rehabilitation medical resources in China are obviously insufficient. Patients who have undergone ACL reconstruction usually return home to work according to the rehabilitation plan. However, the adherence is still poor, and it is difficult to achieve the expected effect. The WeChat public account and its affiliated applets have been widely used in different health fields. The Health Belief Model (HBM) is a guiding theory commonly used in health education to guide patients for behavioral changes. This study aims to use the WeChat small program to explore the effects of optimized the existing Peking University Third Hospital Sports Medicine WeChat small program by using HBM to improve the adherence of patients with home-based functional exercise after ACL injury reconstruction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • (1)Age between 18 and 45;
  • (2)The first time to do simple ACL reconstruction, may be combined with cartilage -dressing and partial meniscectomy, patients with consistent postoperative rehabilitation plans;
  • (3)Having the ability of Basic literacy, communication and accessibility;
  • (4)Having a smartphone, using WeChat or can learn to use WeChat.

排除标准

  • (1)Having history of joint infection, joint tuberculosis or osteomyelitis, or surgery in the lower extremities within 6 months;
  • (2)Being combined with severe heart, brain, kidney and other organ dysfunction;
  • (3)Having other serious knee injuries;
  • (4)Being with mental illness or cognitive impairment, unable to learn and participate in rehabilitation training;
  • (5)Having participated in other similar rehabilitation function training programs, or transferred to other medical institutions after discharge;
  • (6)Doing not disagree to participate in the study,and not sign the informed consent.

结局指标

主要结局

qualified rate of knee joint activity

时间窗: 12 weeks after surgery

Knee joint activity reaches 125 degrees or above is judged to be qualified. Qualified rate is equal to the number of people who meet the standard divided by the total number in each group.

次要结局

  • Visual Analogue Scale(2,6,12 weeks after surgery)
  • International Knee Documentation Committee (IKDC) Subjective Knee Form(2,6,12 weeks after surgery)
  • SF-12 scale(2,6,12 weeks after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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