Department of Orthopaedics and Traumatology, Prince of Wales Hospital, The Chinese University of Hong Kong, Sha Tin, Hong Kong SAR, China.
Department of Orthopaedics and Traumatology, Prince of Wales Hospital, Hospital Authority, Sha Tin, Hong Kong, China.
Trials. 2020 Jan 16;21(1):95. doi: 10.1186/s13063-019-4013-0.
Fractures of the distal radius are one of the most common osteoporotic fractures in elderly men and women. These fractures are a particular health concern amongst the elderly, who are at risk of fragility fractures, and are associated with long-term functional impairment, pain and a variety of complications. This is a sentinel event, as these fractures are associated with a two to four times increased risk of subsequent hip fractures in elderly patients. This is an important concept, as it is well established that these patients have an increased risk of falling. Fall prevention is therefore crucial to decrease further morbidity and mortality. The purpose of this study is to investigate the effect of low-magnitude high-frequency vibration (LMHFV) on postural stability and prevention of falls in elderly patients post distal radius fracture.
This is a prospective single-blinded randomized controlled trial. Two hundred patients will be recruited consecutively with consent, and randomized to either LMHFV (n = 100) or a control group (n = 100). The primary outcome is postural stability measured by the static and dynamic ability of patients to maintain centre of balance on the Biodex Balance System SD. Secondary outcomes are the occurrence of fall(s), the health-related quality of life 36-item short form instrument, the Timed Up and Go test for basic mobility skills, compliance and adverse events. Outcome assessments for both groups will be performed at baseline (0 month) and at 6 weeks, 3 months and 6 months time points.
Previous studies have stressed the importance of reducing falls after distal radius fracture has occurred in elderly patients, and an effective intervention is crucial. Numerous studies have proven vibration therapy to be effective in improving balancing ability in normal patients; However, no previous study has applied the device for patients with fractures. Our study will attempt to translate LMHFV to patients with fractures to improve postural stability and prevent recurrent falls. Positive results would provide a large impact on the prevention of secondary fractures and save healthcare costs.
ClinicalTrials.gov, NCT03380884. Registered on 21 December 2017.
桡骨远端骨折是老年男女中最常见的骨质疏松性骨折之一。这些骨折是老年人特别关注的健康问题，他们有脆性骨折的风险，并与长期功能障碍、疼痛和各种并发症相关。这是一个警戒事件，因为这些骨折与老年患者随后髋部骨折的风险增加 2 至 4 倍相关。这是一个重要的概念，因为已经确定这些患者有更高的跌倒风险。因此，预防跌倒对于降低进一步的发病率和死亡率至关重要。本研究旨在探讨低幅度高频振动（LMHFV）对桡骨远端骨折后老年患者姿势稳定性和预防跌倒的影响。
这是一项前瞻性单盲随机对照试验。将连续征得同意的 200 名患者纳入研究，并随机分为 LMHFV 组（n=100）或对照组（n=100）。主要结局是通过 Biodex Balance System SD 患者维持平衡中心的静态和动态能力来测量的姿势稳定性。次要结局是跌倒（s）的发生、健康相关的 36 项简短形式工具的生活质量、计时起立行走测试（TUGT）以评估基本移动技能、依从性和不良事件。两组的结局评估将在基线（0 个月）和 6 周、3 个月和 6 个月时进行。
以前的研究强调了减少桡骨远端骨折后老年患者跌倒的重要性，有效的干预措施至关重要。许多研究已经证明振动疗法在改善正常患者的平衡能力方面是有效的；然而，以前没有研究将该设备应用于骨折患者。我们的研究将尝试将 LMHFV 应用于骨折患者，以提高姿势稳定性并预防再次跌倒。积极的结果将对预防继发性骨折和节省医疗保健成本产生重大影响。
ClinicalTrials.gov，NCT03380884。于 2017 年 12 月 21 日注册。
