A Prospective Assessment of an Adjustable, Immediate Fit, Transtibial Prosthesis.
A Prospective Assessment of an Adjustable, Immediate Fit, Transtibial Prosthesis.
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对可调，立即拟合，跨态假体的前瞻性评估。
DOI：
10.1002/pmrj.12133
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发表时间：
2019-11
期刊：
影响因子：
--
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中科院分区：
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需要一种可调节的接受腔以适应残肢体积和形状的变化。此外，全球截肢率正在上升，对价格合理且易于获取的假肢系统存在大量未满足的需求。
评估一种即时适配模块化假肢系统（IFIT假肢有限责任公司®）的实用性。
前瞻性可行性研究，包括一项为期两周的家庭单组前后干预研究。
物理医学与康复（PM&R）步态实验室
受试者截肢后至少6个月，并使用传统假肢行走。他们没有皮肤伤口、其他神经系统疾病以及严重疼痛状况。
参与者适配了即时适配假肢，并被要求在两周的评估期内佩戴它。他们被给予一个渐进的佩戴时间表，并在两周的随访时完成结果测量。
（i）自我报告的满意度，（ii）步态生物力学，以及（iii）接受腔内峰值压力。
26名参与者进入研究，其中22名完成了试验。受试者平均年龄为50岁（标准差±10.2）；4名为女性。16名病因是血管病变，10名是创伤性的。在自我报告的满意度方面发现有显著差异（p = 0.03），IFIT装置为29.33（标准差±4.51），优于传统装置的25.52（标准差±6.8）。没有报告跌倒或肢体缺血情况。步态生物力学显示在任何时间特征上没有差异。总体而言，IFIT假肢的接受腔内峰值压力显著更低（p = 0.0014），在胫骨前部（p = 0.0002）和外侧（p = 0.013）也是如此。
在这个短期试验中，IFIT小腿假肢系统似乎是安全的。在所有结果测量方面，它与受试者的传统假肢相比都具有优势。凭借其成本、可调节性和易获取性优势，该装置可能对小腿截肢患者有用。需要一个更大规模的多中心试验来证实这些结果。
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 two-week home single-group pre-post intervention study. PM&R gait laboratory Subjects 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 two-week evaluation period. They were given a progressive wearing schedule and they completed outcome measurements at the two week follow up. Self-reported satisfaction, ii) gait biomechanics, and iii) intrasocket peak pressures. Twenty-six participants entered the study, with twenty-two completing the trial. Subjects averaged 50 years (SD ±10.2) of age; four were female. Sixteen were dysvascular and ten were traumatic in etiology. Significant differences (p= 0.03) in self-reported satisfaction was 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. Intra-socket peak pressures were significantly lower for the IFIT prostheses overall (p = .0014), at the anterior tibia (p=.0002), and the lateral side (p=.013). The IFIT transtibial prosthetic system appears to be safe in this short term trial. It compared favorably to subjects’ 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 multi-center trial is needed to confirm these results.
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发表时间：
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影响因子：
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