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智能膝关节康复监测系统的临床应用研究:一项随机对照试验。

Clinical application research of intelligent monitoring system for knee rehabilitation: a randomized controlled trial.

机构信息

Deparment of Orthopedics, Xiangya Hospital, Central South University, Changsha, 410008, Hunan, China.

National Clinical Research Center for Geriatric Disorders, Xiangya Hospital, Central South University, Changsha, 410008, Hunan, China.

出版信息

J Orthop Surg Res. 2024 Aug 13;19(1):477. doi: 10.1186/s13018-024-04982-8.

Abstract

BACKGROUND

This study investigates the effectiveness of a self-developed intelligent monitoring system for home-based knee rehabilitation following total knee arthroplasty (TKA).

METHODS

In this randomized controlled trial, 120 patients undergoing TKA were divided using random digit allocation. Preoperative and one-month postoperative assessments of knee function, quality of life, and isometric knee extension strength were conducted with the Intelligent Monitoring System. Patients received group-specific rehabilitation instructions pre-discharge and performed exercises for one month.

RESULTS

Changes in isometric knee extensor strength on the affected side within one month post-surgery for the brace-monitored rehabilitation group showed a significant decrease three days after surgery compared to one day before surgery. Subsequent measurements taken at postoperative days 5, 7, 14, and 21 indicated a gradual increase in strength, although these increases did not reach statistical significance when compared with previous measurements. One month post-surgery, all groups demonstrated significant improvements in knee joint function and mobility compared to pre-surgery levels. Notably, the brace-monitored group showed statistically significant improvements in 36-Item Short-Form Health Survey (SF-36) scores over the conventional rehabilitation group.

CONCLUSIONS

The Intelligent Monitoring System provides effective real-time monitoring and guidance for home-based knee rehabilitation post-TKA. It significantly enhances knee joint function, isometric knee extension strength, and quality of life shortly after surgery compared to traditional rehabilitation methods. This system offers a promising approach for improving postoperative recovery in TKA patients.

TRIAL REGISTRATION

This study was approved by the Medical Ethics Committee of Xiangya Hospital, Central South University (Ethics Approval Number 202209008-2). It was registered with the China Clinical Trial Registry, a primary registry of the World Health Organization's International Clinical Trials Registry Platform (Registration Number ChiCTR2300068852).

摘要

背景

本研究旨在探讨一种自行开发的智能监测系统在全膝关节置换(TKA)后居家膝关节康复中的有效性。

方法

这是一项随机对照试验,120 名 TKA 患者采用随机数字分配法分组。使用智能监测系统对患者术前和术后 1 个月的膝关节功能、生活质量和等长膝关节伸肌力量进行评估。患者在出院前接受特定于组别的康复指导,并在出院后进行为期 1 个月的锻炼。

结果

支具监测康复组患者术后 1 个月内患侧等长膝关节伸肌力量的变化,术后第 3 天与术前第 1 天相比,力量明显下降。随后在术后第 5、7、14 和 21 天的测量结果显示力量逐渐增加,但与之前的测量结果相比,这些增加没有达到统计学意义。术后 1 个月,所有组的膝关节功能和活动度均较术前显著改善。值得注意的是,与常规康复组相比,支具监测组在 36 项简明健康调查问卷(SF-36)评分方面表现出统计学上的显著改善。

结论

智能监测系统为 TKA 后居家膝关节康复提供了有效的实时监测和指导。与传统康复方法相比,它在术后短期内显著提高了膝关节功能、等长膝关节伸肌力量和生活质量。该系统为改善 TKA 患者术后康复提供了一种有前景的方法。

试验注册

本研究经中南大学湘雅医院医学伦理委员会批准(伦理批准号 202209008-2)。研究在中国临床试验注册中心(世界卫生组织国际临床试验注册平台一级注册机构)进行注册(注册号 ChiCTR2300068852)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3579/11321123/4be97cc99bf8/13018_2024_4982_Fig1_HTML.jpg

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