伊朗全膝关节置换术后患者远程康复干预的可行性和可接受性：随机对照试验方案。

Feasibility and acceptability of a telerehabilitation intervention on patients undergoing total knee arthroplasty in Iran: randomised controlled trial protocol.

机构信息

Department of Physiotherapy, Iran University of Medical Sciences, Tehran, Iran (the Islamic Republic of).

Department of Orthopedic Surgery, Shahid Beheshti University of Medical Sciences, Tehran, Iran (the Islamic Republic of).

出版信息

BMJ Open. 2024 Jun 10;14(6):e083784. doi: 10.1136/bmjopen-2023-083784.

DOI:10.1136/bmjopen-2023-083784

PMID:38858143

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11168134/

Abstract

INTRODUCTION

Telerehabilitation is a promising avenue to enhance post-total knee arthroplasty (TKA) rehabilitation by improving accessibility, convenience and cost-effectiveness. Despite its potential benefits, its application in the context of TKA in Iran is in its early stages, lacking comprehensive studies on feasibility, acceptance and programme adherence. This article outlines a protocol for an open-label, parallel-group, randomised controlled trial investigating the impact of a 4 week telerehabilitation programme alongside usual care.

METHODS

Thirty patients (aged 50-90) undergoing TKA for severe Knee Osteoarthritis at Atiyeh Hospital in Tehran, Iran, will be recruited using block randomisation. Participants will be assigned to either the intervention group, receiving telerehabilitation or the control group without telerehabilitation. The intervention will include virtual physiotherapy sessions thrice weekly, lasting 30-45 min each, over 4 weeks. The primary objective is to assess the feasibility and acceptability of telerehabilitation, measured through recruitment and attrition rates, questionnaire completion rates, patient satisfaction using appropriate questionnaire and adherence to the intervention. Secondary outcomes encompass four Knee Injury and Osteoarthritis Outcome Score questionnaire subscales (function in Activities of Daily Living, Pain, Symptoms, Quality of Life). Patient global assessment will use a standardised question. An online survey will evaluate walking assistant device usage, exercise adherence and adverse events. The number of individuals receiving in-person rehabilitation will be documented after the first postoperative surgeon visit. Assessments occur at baseline and 4 weeks postsurgery.

ANALYSIS

Statistical analysis, including independent samples t-test, paired samples t-test, χ2 test, Fisher's exact test, analysis of covariance and multiple linear regression, will use SPSS software version 16, with significance set at p<0.05.

ETHICS AND DISSEMINATION

Approved by AJA University of Medical Sciences Ethics Committee (IR.AJAUMS.REC.1402.126), trial results will be presented to relevant groups and published in peer-reviewed journals.

TRIAL REGISTRATION NUMBER

TCTR20231020004.

摘要

简介

远程康复是一种有前途的途径，可以通过提高可及性、便利性和成本效益来增强全膝关节置换术后（TKA）的康复。尽管它具有潜在的益处，但在伊朗 TKA 的背景下，它的应用还处于早期阶段，缺乏对可行性、接受度和方案依从性的全面研究。本文概述了一项方案，该方案采用开放标签、平行组、随机对照试验，研究了在常规护理基础上加入 4 周远程康复方案的影响。

方法

在伊朗德黑兰 Atiyeh 医院接受 TKA 治疗严重膝关节骨关节炎的 30 名患者（年龄 50-90 岁）将通过块随机化招募。参与者将被分配到干预组或对照组。干预组将接受每周三次的虚拟物理治疗，每次 30-45 分钟，持续 4 周。主要目的是通过招募和脱落率、问卷完成率、使用适当问卷的患者满意度和对干预的依从性来评估远程康复的可行性和可接受性。次要结果包括四个膝关节损伤和骨关节炎结果评分问卷子量表（日常生活活动中的功能、疼痛、症状、生活质量）。患者整体评估将使用标准问题。在线调查将评估助行器的使用、运动依从性和不良事件。将记录术后第一次就诊时接受面对面康复治疗的人数。评估在基线和术后 4 周进行。