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

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

Abstract

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.