Helfenstein Andreas, Lankes Michael, Ohlert Katharina, Varoga Deike, Hahne Hans-Jürgen, Ulrich Hans Wolfram, Hassenpflug Joachim
Department of Orthopedic Surgery, University of Kiel, Kiel, Germany.
Spine (Phila Pa 1976). 2006 Feb 1;31(3):339-44. doi: 10.1097/01.brs.0000197412.70050.0d.
Prospective study using a specifically developed microelectronic technology.
To establish new technical methods for the objective measurement of brace use without patient involvement.
Effectiveness of spinal bracing clearly depends on the compliance of the patient. For further improvement of spinal bracing, reliable data are needed concerning the brace use. Questionnaires or clinical judgment usually estimates subjectively the compliance, which ranges from 20% to 90%. So far, only 1 study with 10 patients has investigated the compliance by objective time-stamped logging in a daily life environment, showing an average brace use of 65%.
There were 9 female patients (age 14.2 years, standard deviation 1.5) with adolescent idiopathic scoliosis who took part in the study. Their thoracolumbosacral orthoses (Chêneau braces OT-Kiel, Kiel, Germany) were equipped with a specifically developed discrete data logger to record temperature at the skin-brace interface over a period of 5.4 weeks (standard deviation 3.1), at 2-minute date/time-stamped intervals.
Brace use ranged from 4.2 to 22.4 hours per day (average 15.4 hours). Underlying the recommended bracing time of 23 hours, average compliance rate was 67.5% (range 19.0% to 97.1%). No patient reached a complete 23-hour bracing. Patients with poor compliance usually removed the brace during the daytime. The individual bracing pattern did not change over the course of an evaluation period, and the compliance can be estimated after 2 weeks.
Long-term logging of temperature within a spinal orthosis is a reliable and simple way to measure objectively the compliance. Thus, comparison of full-time and part-time bracing is made possible on an objective basis. Furthermore, knowing the bracing pattern provides a better focus on other variables of spinal bracing, such as the force distribution within the brace. This knowledge may help to improve further the shape and effectiveness of bracing.
采用专门开发的微电子技术进行前瞻性研究。
建立在无需患者参与的情况下客观测量支具使用情况的新技术方法。
脊柱支具的有效性显然取决于患者的依从性。为了进一步改进脊柱支具，需要有关支具使用的可靠数据。问卷调查或临床判断通常主观估计依从性，其范围为20%至90%。到目前为止，仅有1项对10名患者的研究在日常生活环境中通过客观的时间标记记录来调查依从性，结果显示支具平均使用时间为65%。
9名患有青少年特发性脊柱侧凸的女性患者（年龄14.2岁，标准差1.5）参与了本研究。她们佩戴的胸腰骶矫形器（德国基尔的Chêneau支具OT-Kiel）配备了专门开发的离散数据记录器，以2分钟的日期/时间标记间隔记录皮肤与支具界面处的温度，为期5.4周（标准差3.1）。
支具每天使用时间为4.2至22.4小时（平均15.4小时）。按照推荐的23小时佩戴时间计算，平均依从率为67.5%（范围为19.0%至97.1%）。没有患者达到完全23小时的佩戴时间。依从性差的患者通常在白天摘掉支具。在评估期间，个体的支具佩戴模式没有变化，2周后即可估计依从性。
在脊柱矫形器内长期记录温度是客观测量依从性的一种可靠且简单的方法。因此，可以在客观基础上对全天和部分时间佩戴支具进行比较。此外，了解支具佩戴模式有助于更好地关注脊柱支具的其他变量，如支具内的力分布。这些知识可能有助于进一步改善支具的形状和有效性。
