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Hull 早期助行器在胫骨截肢患者康复中的应用——随机对照试验(HEART)。

Hull early walking aid for rehabilitation of transtibial amputees--randomized controlled trial (HEART).

机构信息

Academic Vascular Surgery Unit, University of Hull, Hull, United Kingdom.

出版信息

J Vasc Surg. 2010 Dec;52(6):1564-71. doi: 10.1016/j.jvs.2010.07.006. Epub 2010 Sep 19.

DOI:10.1016/j.jvs.2010.07.006
PMID:20855178
Abstract

PURPOSE

To compare articulated and nonarticulated early walking aids (EWAs) for clinical and quality-of-life outcomes in transtibial amputees.

METHODS

Patients undergoing lower limb amputation in a tertiary-care vascular surgical unit were screened over a 4-year period. Recruited patients were randomized to receive articulated amputee mobility aid (AMA) or nonarticulated pneumatic postamputation mobility aid (PPAMA) during early rehabilitation. Primary (10-meter walking velocity) and secondary clinical (number and duration of physiotherapy treatments during EWA/prosthesis use) and quality-of-life (SF-36) outcome measures were recorded at five standardized assessment visits. Inter-group and intra-group analyses were performed.

RESULTS

Two hundred seventy-two patients were screened and 29 transtibial amputees (median age, 56 years) were recruited (14/treatment arm). No significant difference was seen in demographics and comorbidities at baseline. Inter-group analysis: Median 10-meter walking velocity was significantly (Mann-Whitney, P = .020) faster in the PPAMA group (0.245 m/s, interquartile range [IQR] 0.218-0.402 m/s) compared with the AMA group (0.165 m/s; IQR, 0.118-0.265 m/s) at visit 1. However, there was no difference between the groups at any other visit. Similarly, the number of treatments using EWA was significantly (P = .045) lower in the PPAMA group (5.0; IQR, 3.5-8.0) compared with the AMA group (6.0; IQR, 6.0-10.5). No difference was observed between the groups in duration of physiotherapy or SF-36 domain and summary scores. Intra-group analysis: Both treatment groups showed significant improvement in 10-meter walking velocity (Friedman test; AMA P = .001; PPAMA P = .007); however, other clinical outcomes did not show any statistically significant improvement. Only physical function domain of SF-36 demonstrated significant improvement (Friedman test; AMA P = .037; PPAMA P = .029).

CONCLUSIONS

There is no difference in clinical and QOL outcomes between articulated and nonarticulated EWAs in rehabilitation of transtibial amputees.

摘要

目的

比较关节式和非关节式早期助行器(EWA)在胫骨截肢患者中的临床和生活质量结局。

方法

在一家三级保健血管外科病房,对 4 年内接受下肢截肢的患者进行了筛选。招募的患者在早期康复期间被随机分配接受关节式截肢患者移动辅助器(AMA)或非关节式气压截肢后移动辅助器(PPAMA)。在 5 次标准化评估访视时记录主要(10 米步行速度)和次要临床(EWA/假肢使用期间物理治疗治疗的次数和持续时间)和生活质量(SF-36)结局测量值。进行了组间和组内分析。

结果

对 272 名患者进行了筛查,招募了 29 名胫骨截肢患者(中位年龄 56 岁)(每组 14 名)。基线时,两组在人口统计学和合并症方面无显著差异。组间分析:在第 1 次访视时,PPAMA 组的中位 10 米步行速度明显(Mann-Whitney,P=0.020)快于 AMA 组(0.245m/s,四分位距 [IQR] 0.218-0.402m/s)。然而,在任何其他访视时,两组之间均无差异。同样,PPAMA 组(5.0;IQR,3.5-8.0)使用 EWA 的治疗次数明显(P=0.045)少于 AMA 组(6.0;IQR,6.0-10.5)。两组在物理治疗或 SF-36 领域和综合评分的持续时间方面没有差异。组内分析:两组均表现出 10 米步行速度的显著改善(Friedman 检验;AMA P=0.001;PPAMA P=0.007);然而,其他临床结局并没有显示出任何统计学上的显著改善。只有 SF-36 的身体功能领域表现出显著改善(Friedman 检验;AMA P=0.037;PPAMA P=0.029)。

结论

在胫骨截肢患者的康复中,关节式和非关节式 EWA 在临床和生活质量结局方面没有差异。

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