Human Performance Laboratory, Department of Rehabilitation, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.
Arch Phys Med Rehabil. 2012 Nov;93(11):2075-9. doi: 10.1016/j.apmr.2012.06.019. Epub 2012 Jul 4.
To assess the validity and feasibility of a new temperature-based adherence monitor to measure footwear use.
Observational study.
University medical center and participants' homes.
Convenience sample of healthy subjects (n=11) and neuropathic diabetic patients at high risk for foot ulceration (n=14).
In healthy subjects, the validity of the in-shoe attached adherence monitor was investigated by comparing its registrations of donning and doffing of footwear during 7 days to an accurately kept log registration. In diabetic patients, the feasibility of using the adherence monitor for 7 days in conjunction with a time-synchronized ankle-worn step activity monitor to register prescribed footwear use during walking was assessed. Furthermore, a usability questionnaire was completed.
For validity, the mean time difference and 95% confidence interval (CI) between moments of donning/doffing footwear recorded with the adherence monitor and in the log were calculated. For feasibility, technical performance, usability, and the percentage of steps that the footwear was worn (adherence) were assessed.
The mean time difference between the adherence monitor and log recordings was 0.4 minutes (95% CI, 0.2-0.6min). One erroneous recording and 2 incomplete recordings were obtained in diabetic patients. Three patients reported discomfort with the step activity monitor, and 4 patients would not favor repeated testing. Patients used their footwear for between 9% and 99% of their walking steps.
The adherence monitor shows good validity in measuring when footwear is used or not, and is, together with instrumented monitoring of walking activity, a feasible and objective method to assess treatment adherence. This method can have wide application in clinical practice and research regarding prescribed footwear and other body-worn assistive devices.
评估一种新的基于温度的依从性监测仪测量鞋类使用的有效性和可行性。
观察性研究。
大学医学中心和参与者的家庭。
健康受试者（n=11）和有发生足部溃疡高风险的神经病变糖尿病患者（n=14）的便利样本。
在健康受试者中，通过将附着在鞋内的依从性监测仪记录的 7 天内穿脱鞋次数与准确记录的日志进行比较，来评估其对鞋类使用的测量准确性。在糖尿病患者中，评估了在 7 天内同时使用依从性监测仪和时间同步的踝部佩戴式步活动监测仪来记录规定的步行鞋类使用的可行性，同时还完成了一份使用情况调查问卷。
对于有效性，计算了依从性监测仪和日志记录的穿脱鞋时间之间的平均时间差和 95%置信区间（CI）。对于可行性，评估了技术性能、可用性以及鞋类的穿戴比例（依从性）。
依从性监测仪与日志记录之间的平均时间差为 0.4 分钟（95%CI，0.2-0.6min）。在糖尿病患者中，有 1 个错误记录和 2 个不完整记录。3 名患者报告佩戴步活动监测仪时感到不适，4 名患者不倾向于重复测试。患者在步行过程中使用鞋类的比例在 9%至 99%之间。
该依从性监测仪在测量何时使用或不使用鞋类方面具有较好的准确性，与仪器监测步行活动一起，是评估治疗依从性的一种可行且客观的方法。这种方法可以在规定的鞋类和其他穿戴式辅助设备的临床实践和研究中得到广泛应用。
