Walter Reed National Military Medical Center, Bethesda, Maryland.
Naval Medical Center San Diego, San Diego, California.
J Bone Joint Surg Am. 2018 Oct 17;100(20):1781-1789. doi: 10.2106/JBJS.18.00213.
The Intrepid Dynamic Exoskeletal Orthosis (IDEO) is a custom energy-storing carbon fiber ankle-foot orthosis developed for lower-extremity trauma patients. Studies conducted at the military treatment facility where the IDEO was developed demonstrated benefits of the IDEO when used with the Return to Run Physical Therapy (RTR PT) program. The current study was designed to determine if results could be replicated at other military treatment facilities and to examine whether early performance gains in patient-reported functional outcomes remained at 12 months.
Study participants included service members who had functional deficits that interfered with daily activities at least 1 year after a traumatic unilateral lower-extremity injury at or below the knee. Participants were evaluated before receiving the IDEO, immediately following completion of RTR PT, and at 6 and 12 months. Agility, strength/power, and speed were assessed using well-established performance tests. Self-reported function was measured using the Short Musculoskeletal Function Assessment (SMFA). The Orthotics and Prosthetics Users' Survey was administered to assess satisfaction with the IDEO. Of 87 participants with complete baseline data, 6 did not complete any physical therapy and were excluded from the analysis. Follow-up rates immediately following completion of the RTR PT and at 6 and 12 months were 88%, 75%, and 79%, respectively.
Compared with baseline, improvement at completion of RTR PT was observed in all but 1 performance test. SMFA scores for all domains except hand and arm function were lower (improved function) at 6 and 12 months. Satisfaction with the IDEO was high following completion of RTR PT, with some attenuation at the time of follow-up.
This study adds to the evidence supporting the efficacy of the IDEO coupled with RTR PT. However, despite improvement in both performance and self-reported functioning, deficits persist compared with population norms.
Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.
Intrepid Dynamic Exoskeletal Orthosis（IDEO）是一种定制的储能碳纤维踝足矫形器，专为下肢创伤患者开发。在开发 IDEO 的军事治疗设施进行的研究表明，当与 Return to Run 物理治疗（RTR PT）计划一起使用时，IDEO 具有优势。本研究旨在确定是否可以在其他军事治疗设施复制结果，并检查患者报告的功能结果的早期收益是否在 12 个月时仍然存在。
研究参与者包括功能缺陷至少 1 年的服务人员，这些缺陷在膝部以下的单侧下肢创伤后干扰了日常活动。参与者在接受 IDEO 之前、完成 RTR PT 后立即以及 6 个月和 12 个月进行评估。使用成熟的性能测试评估敏捷性、力量/功率和速度。使用短期肌肉骨骼功能评估（SMFA）测量自我报告的功能。使用矫形器和假肢用户调查评估对 IDEO 的满意度。在有完整基线数据的 87 名参与者中，有 6 名未完成任何物理治疗，因此被排除在分析之外。完成 RTR PT 后和 6 个月和 12 个月的随访率分别为 88%、75%和 79%。
与基线相比，除了 1 项性能测试外，所有测试在完成 RTR PT 时都有改善。除手部和手臂功能外，所有领域的 SMFA 评分在 6 个月和 12 个月时均较低（功能改善）。完成 RTR PT 后，对 IDEO 的满意度很高，但在随访时有所减弱。
本研究增加了支持 IDEO 与 RTR PT 结合的疗效的证据。然而，尽管在性能和自我报告功能方面都有所改善，但与人群标准相比，仍存在缺陷。
治疗水平 IV。有关完整的证据水平描述，请参阅作者说明。
