Department of Physical Medicine and Rehabilitation, University of Pennsylvania School of Medicine, Philadelphia, PA.
Department of Emergency Medicine, University of Pennsylvania School of Medicine, Philadelphia, PA.
PM R. 2019 Nov;11(11):1210-1217. doi: 10.1002/pmrj.12133. Epub 2019 Apr 1.
There exists a need for an adjustable socket to accommodate residual limb volume and shape changes. Further, limb loss rates globally are rising and there is a large unmet need for affordable and accessible prosthetic systems.
To assess the utility of an immediate fit modular prosthetic system (iFIT Prosthetics, LLC).
Prospective feasibility study involving a 2-week single-group pre-post intervention study.
Physical Medicine and Rehabilitation gait laboratory.
Participants were at least 6 months post amputation and walking with a conventional prosthesis. They were free of skin wounds, other neurological disorders, and severe pain conditions.
Participants were fit with an immediate fit prosthesis and instructed to wear it for a 2-week evaluation period. They were given a progressive wearing schedule and they completed outcome measurements at the 2-week follow-up.
Self-reported satisfaction, gait biomechanics, and intrasocket peak pressures.
Twenty-six participants entered the study, with 22 completing the single group pre-post study. They averaged 50 years (SD ±10.2) of age; four were female. Sixteen were dysvascular and 10 were traumatic in etiology. Significant differences (P = .03) in self-reported satisfaction were found in favor of the iFIT device 29.33 (SD ± 4.51) versus the conventional device 25.52 (SD ± 6.8). No falls or limb ischemia were reported. Gait biomechanics revealed no differences across any temporal characteristics. Intrasocket peak pressures were significantly lower for the iFIT prostheses overall (P = .0014), at the anterior tibia (P = .0002), and the lateral side of the residual limb (P = .013).
The iFIT transtibial prosthetic system appears to be safe in this short-term single-group pre-post study. This study provided preliminary evidence to support the feasibility of the iFIT system. It compared favorably to participants' conventional prostheses across all outcome measures. With its cost, adjustability, and accessibility advantages, this device may prove useful for persons with transtibial amputations. A larger multicenter study is needed to confirm these results.
III.
需要一种可调节的接受腔来适应残肢体积和形状的变化。此外，全球的截肢率正在上升，对于负担得起和可获得的假肢系统的需求很大。
评估一种即时适配模块化假肢系统（iFIT 假肢，LLC）的实用性。
前瞻性可行性研究，包括 2 周的单组前后干预研究。
物理医学与康复步态实验室。
参与者至少在截肢后 6 个月，并使用传统假肢行走。他们没有皮肤伤口、其他神经障碍和严重疼痛状况。
参与者配备即时适配假肢，并被要求在 2 周的评估期内佩戴。他们接受了一个渐进的佩戴计划，并在 2 周的随访中完成了结果测量。
自我报告的满意度、步态生物力学和接受腔内峰值压力。
26 名参与者进入研究，其中 22 名完成了单组前后研究。他们的平均年龄为 50 岁（SD ±10.2）；4 名女性。16 名是血管疾病，10 名是创伤性病因。自我报告的满意度有显著差异（P =.03），iFIT 装置为 29.33（SD ±4.51），而传统装置为 25.52（SD ±6.8）。没有报告跌倒或肢体缺血。步态生物力学显示，在任何时间特征方面都没有差异。接受腔内峰值压力总体上，iFIT 假肢明显较低（P =.0014），在前胫骨（P =.0002）和残肢的外侧（P =.013）。
在这项短期单组前后研究中，iFIT 胫骨假肢系统似乎是安全的。这项研究提供了初步证据支持 iFIT 系统的可行性。它在所有结果测量中都优于参与者的传统假肢。由于其成本、可调节性和可及性优势，该设备可能对胫骨截肢者有用。需要更大的多中心研究来证实这些结果。
III。
