Data_Sheet_3_Postadychute-AG, Detection, and Prevention of the Risk of Falling Among Elderly People in Nursing Homes: Protocol of a Multicentre and Prospective Intervention Study.PDF

Introduction: While falls among the elderly is a public health issue, because of the social, medical, and economic burden they represent, the tools to predict falls are limited. Posturography has been developed to distinguish fallers from non-fallers, however, there is too little data to show how predictions change as older adults' physical abilities improve. The Postadychute-AG clinical trial aims to evaluate the evolution of posturographic parameters in relation to the improvement of balance through adapted physical activity (APA) programs.
Methods: In this prospective, multicentre clinical trial, institutionalized seniors over 65 years of age will be followed for a period of 6 months through computer-assisted posturography and automatic gait analysis. During the entire duration of the follow-up, they will benefit from a monthly measurement of their postural and locomotion capacities through a recording of their static balance and gait thanks to a software developed for this purpose. The data gathered will be correlated with the daily record of falls in the institution. Static and dynamic balance measurements aim to extract biomechanical markers and compare them with functional assessments of motor skills (Berg Balance Scale and Mini Motor Test), expecting their superiority in predicting the number of falls. Participants will be followed for 3 months without APA and 3 months with APA in homogeneous group exercises. An analysis of variance will evaluate the variability of monthly measures of balance in order to record the minimum clinically detectable change (MDC) as participants improve their physical condition through APA.
Discussion: Previous studies have stated the MDC through repeated measurements of balance but, to our knowledge, none appear to have implemented monthly measurements of balance and gait. Combined with a reliable measure of the number of falls per person, motor capacities and other precipitating factors, this study aims to provide biomechanical markers predictive of fall risk with their sensitivity to improvement in clinical status over the medium term. This trial could provide the basis for posturographic and gait variable values for these elderly people and provide a solution to distinguish those most at risk to be implemented in current practice in nursing homes.
Trial Registration: ID-RCB 2017-A02545-48.
Protocol Version: Version 4.2 dated January 8, 2020.

引言：老年人跌倒是一项公共卫生问题，因其带来社会、医疗与经济负担，当前用于预测跌倒的工具仍十分有限。姿势图（Posturography）已被开发用于区分跌倒高风险人群与非跌倒高风险人群，但现有数据不足以阐明随着老年群体身体机能改善时，跌倒预测结果的变化情况。Postadychute-AG临床试验旨在评估通过适应体育活动（Adapted Physical Activity, APA）方案改善平衡能力后，姿势图参数的演变趋势。

方法：本项前瞻性多中心临床试验将对65岁以上的机构养老老年人开展为期6个月的随访，通过计算机辅助姿势图与自动步态分析进行评估。在整个随访周期内，将借助专为本次研究开发的软件，通过静态平衡与步态记录，每月对受试者的姿势与运动能力进行测量。收集到的数据将与养老机构内的每日跌倒记录进行关联分析。静态与动态平衡测量旨在提取生物力学标志物，并与运动功能评估结果（Berg平衡量表（Berg Balance Scale）与迷你运动测试（Mini Motor Test））进行对比，以期这些标志物在预测跌倒次数方面具备更优效能。受试者将被分为两个阶段：先进行3个月无适应体育活动的随访，再进行3个月的同质性小组适应体育活动训练。本研究将通过方差分析评估每月平衡测量结果的变异性，以记录受试者通过适应体育活动改善身体机能时的临床最小可检测变化（Minimum Clinically Detectable Change, MDC）。

讨论：既往研究已通过重复平衡测量确定了临床最小可检测变化，但据我们所知，尚无研究开展每月平衡与步态的月度测量。本研究将结合可靠的个人跌倒次数记录、运动能力及其他诱发因素，旨在提取可预测跌倒风险的生物力学标志物，并评估其在中期内对临床状态改善的敏感性。本试验可为该老年人群的姿势图与步态变量提供参考值，并可为养老机构当前的临床实践提供区分高跌倒风险人群的解决方案。

试验注册：ID-RCB 2017-A02545-48。
协议版本：版本4.2，发布于2020年1月8日。