Department of Physical Medicine and Rehabilitation, Northwestern University, Feinberg School of Medicine, Chicago, IL.
Department of Physical Medicine and Rehabilitation, Northwestern University, Feinberg School of Medicine, Chicago, IL; Scheck and Siress Prosthetics and Orthotics, Chicago, IL; Hanger Clinic, Austin, TX.
Arch Phys Med Rehabil. 2021 Nov;102(11):2063-2073.e2. doi: 10.1016/j.apmr.2021.05.016. Epub 2021 Jun 29.
To compare comfort and functional performance of the Northwestern University Flexible Subischial Vacuum (NU-FlexSIV) Socket with the ischial containment (IC) socket in persons with unilateral transfemoral amputation.
Randomized crossover trial with two 7-week periods.
Private prosthetic clinics and university research laboratory.
A total of 30 enrolled (N=30); 25 participants completed the study with full (n=18) or partial data (n=7).
Two custom-fabricated sockets (IC and NU-FlexSIV), worn full-time for 7 weeks, with testing at 1, 4, and 7 weeks after socket delivery.
The primary outcome was change in Socket Comfort Score (SCS) at 7 weeks. Secondary outcomes at 7 weeks included the Orthotic and Prosthetic Users' Survey (OPUS) to assess lower extremity functional status, health-related quality of life, and satisfaction with device, as well as the 5-Times Rapid Sit-to-Stand Test, Four Square Step Test, and T-Test of Agility to assess functional performance.
At 7 weeks, the mean SCS for IC (7.0±1.7) and NU-FlexSIV (8.4±1.1) Sockets were significantly different (P<.001; 95% confidence interval, 0.8-2.3). Results from a linear mixed-effects model, accounting for data from all time points, indicated that the SCS was 1.7 (SE=0.45) points higher for the NU-FlexSIV Socket (P<.001). For the secondary outcomes, only OPUS satisfaction with device was significantly better in the NU-FlexSIV Socket after accounting for all data points.
The results suggest that after 7 weeks' accommodation, the NU-FlexSIV Socket was more comfortable and led to greater satisfaction with device than the IC socket in persons with unilateral transfemoral amputation and K3/K4 mobility. Other patient-reported outcomes and function were no different between sockets.
比较西北大学柔性坐骨下真空（NU-FlexSIV）插座与坐骨包容（IC）插座在单侧股骨截肢患者中的舒适度和功能表现。
随机交叉试验，两个 7 周周期。
私人假肢诊所和大学研究实验室。
共纳入 30 人（N=30）；25 名参与者完成了研究，其中 18 名完成了全部数据，7 名完成了部分数据。
两种定制插座（IC 和 NU-FlexSIV），佩戴 7 周，在插座交付后 1、4 和 7 周进行测试。
主要结果是 7 周时插座舒适度评分（SCS）的变化。7 周时的次要结果包括矫形和假肢使用者调查（OPUS），以评估下肢功能状态、健康相关生活质量和对设备的满意度，以及 5 次快速坐立测试、四方步测试和敏捷 T 测试，以评估功能表现。
7 周时，IC（7.0±1.7）和 NU-FlexSIV（8.4±1.1）插座的平均 SCS 差异有统计学意义（P<.001；95%置信区间，0.8-2.3）。线性混合效应模型分析所有时间点的数据表明，NU-FlexSIV 插座的 SCS 高 1.7（SE=0.45）分（P<.001）。对于次要结果，仅在考虑所有数据点后，NU-FlexSIV 插座的 OPUS 对设备的满意度显著更高。
结果表明，在适应 7 周后，NU-FlexSIV 插座在单侧股骨截肢和 K3/K4 活动能力患者中比 IC 插座更舒适，患者对设备的满意度更高。其他患者报告的结果和功能在插座之间没有差异。
