Impact of Gait Analysis on Surgical Outcomes

描述(由申请人提供)：步态分析测试已被用于协助骨科医生为步态异常儿童，特别是脑瘫儿童制定治疗计划。先前的研究表明，步态分析测试对这些患者的手术决策有重大影响。然而，还没有进行对照研究来确定步态分析和手术决策的后续变化是否会影响临床结果。因此，步态分析在临床实践中的使用仍然存在争议。这项研究的目的是进行一项随机对照试验，以评估术前步态分析对脑瘫儿童手术结果的影响。具体目的是确定步态分析数据的使用是否导致(1)行走能力和效率的更大改善，(2)粗大运动功能的更大改善，(3)总体患者福祉和生活质量的更大改善，以及(4)与没有步态分析数据时提供的治疗相比，对额外治疗的需要更少。 本研究将是一项随机对照试验。患者将随机决定是否将其术前步态分析数据包括在治疗决策过程中。将对所有患者进行全面的术前和术后一年的步态分析研究，以及粗大运动功能测试和评估儿童总体健康和幸福感的问卷调查。术后，是否需要额外的治疗将由独立的儿科整形外科医生进行评估。将比较在治疗决策过程中步态数据可用的患者和步态数据不可用的患者之间的1年结果。这一结果将决定步态分析测试的使用是否会改善因脑瘫而有行走问题的儿童的临床结果。

DESCRIPTION (provided by the applicant): Gait analysis testing has been used to assist orthopedic surgeons in developing treatment plans for children with gait abnormalities, particularly children with cerebral palsy. Previous studies have shown that gait analysis testing significantly impacts surgical decision-making for these patients. However, no controlled studies have been done to determine whether gait analysis and the subsequent changes in surgical decision-making affect clinical outcomes. Consequently, the use of gait analysis in clinical practice remains controversial. The purpose of this study is to conduct a randomized controlled trial to assess the effects of preoperative gait analysis on surgical outcomes in ambulatory children with cerebral palsy. The specific aims are to determine whether the use of gait analysis data results in (1) greater improvements in walking ability and efficiency, (2) greater improvements in gross motor function, (3) greater improvements in overall patient well being and quality of life, and (4) less need for additional treatment compared with treatment provided when gait analysis data are not available. This study will be a randomized controlled trial. Patients will be randomized as to whether or not their preoperative gait analysis data are included in the treatment decision-making process. Comprehensive pre and 1-year postoperative gait analysis studies will be performed for all patients, along with gross motor function testing and questionnaires that assess a child's general health and well being. Postoperatively, the need for additional treatments will be assessed by an independent pediatric orthopaedic surgeon. 1-year outcomes will be compared between the patients whose gait data were available during the treatment decision-making process and the patients whose gait data were not available. The results will determine whether the use of gait analysis testing improves clinical outcomes in children who have walking problems due to cerebral palsy.