预防跌倒项目对全膝关节置换术后跌倒频率的短期和长期影响：一项实用的单盲随机对照试验方案

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-02-06 DOI:10.1016/j.cct.2025.107837

Hadeel Al-Saleh , Eman Merza , Bader Al-Adwanie , Stephen Pearson , Peter Malliaras

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引用次数: 0

摘要

背景：全膝关节置换术（TKR）后跌倒是一个重要的问题，可导致严重的致命和非致命伤害。本研究旨在调查将跌倒预防项目纳入常规物理治疗与常规物理治疗对TKR患者跌倒次数的短期和长期影响，以及随后对平衡和功能能力的影响。方法和设计这是一项平行组前瞻性（52周）随机单盲实用对照试验，在科威特的Alrazi骨科医院进行。样本量为90人（每组45人）。参与者将被随机分为干预组和对照组。结果测量将在基线、12周和52周时收集，研究者对治疗分配不知情。主要预后指标为TKR手术后52周的跌倒率评估。次要结果包括膝关节活动度、疼痛严重程度、10米步行测试、定时起身和行走测试、伯格平衡量表、30秒坐立、患者对家庭计划的依从性和患者满意度。将采用双向多变量方差分析（组×时间）来评估各组（实验组和对照组）随时间（基线、12周和52周）的差异。研究可以减少或预防TKR患者跌倒风险的物理治疗方案似乎很重要。这项拟议的研究将是确定运动计划的第一步，该计划可以有效地减少TKR患者的跌倒次数。试验注册：ClinicalTrials.gov，标识符NCT05642260

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The short- and long-term effects of a fall prevention program on the frequency of falls following total knee replacement: A pragmatic single-blinded randomized controlled trial protocol

Background

Falling following total knee replacement (TKR) is a significant issue, and can result in serious fatal and non-fatal injuries. The proposed study aims to investigate the short and long-term effects of integrating a falls prevention program into conventional physiotherapy versus just conventional physiotherapy on the number of falls, and any subsequent effects on balance, and functional ability among TKR patients.

Methods and design

This is a parallel group prospective (52 weeks) randomized single-blinded pragmatic controlled trial conducted at Alrazi Orthopedic Hospital, in Kuwait. Sample size will be 90 pariticpants (45 participants in each group). Particpants will be randomized to intervention or control group. Outcome measures will be collected at baseline, 12 weeks and 52 weeks by investigators who are blinded to treatment allocation. Primary outcome will be fall rate assessed at 52 weeks following the TKR surgery. Secondary outcomes will include knee range of motion, severity of pain, 10-m walk test, Timed Up and Go test, Berg Balance Scale, 30-s sit to stand, patient adherence to home program and patient's satisfaction. Two-way multivariate ANOVA (group × time) will be performed to assess the group (experimental and control group) differences over time (baseline, 12, and 52 weeks).

Discussion

Investigating the physiotherapy programs that could minimize or prevent the risk of falling among TKR patients seems important. The proposed study will be the first step toward determining the exercise program that could be effective in reducing the number of falls among TKR patients.

Trial Registration: ClinicalTrials.gov, Identifier NCT05642260

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.