Raaben Marco, Redzwan Syaiful, Augustine Robin, Blokhuis Taco Johan
Department of Surgery, University Medical Center Utrecht, Heidelberglaan 100, 3508 GA, Utrecht, The Netherlands.
Department of Engineering Sciences, Uppsala University, Lägerhyddsvägen 1, SE751 21, Uppsala, Sweden.
Trials. 2018 Apr 12;19(1):220. doi: 10.1186/s13063-018-2612-9.
Proximal femur fractures are a common injury after low energy trauma in the elderly. Most rehabilitation programs are based on restoring mobility and early resumption of weight-bearing. However, therapy compliance is low in patients following lower extremity fractures. Moreover, little is known about the relevance of gait parameters and how to steer the rehabilitation after proximal femur fractures in the elderly. Therefore, the aim of this prospective, randomized controlled trial is to gain insight in gait parameters and evaluate if real-time visual biofeedback can improve therapy compliance after proximal femur fractures in the elderly.
This is a two-arm, parallel-design, prospective, randomized controlled trial. Inclusion criteria are age ≥ 60 years, a proximal femur fracture following low energy trauma, and unrestricted-weight bearing. Exclusion criteria are cognitive impairment and limited mobility before trauma. Participants are randomized into either the control group, which receives care as usual, or the intervention group, which receives real-time visual biofeedback about weight-bearing during gait in addition to care as usual. Spatiotemporal gait parameters will be measured in 94 participants per group during a 30-m walk with an ambulatory biofeedback system (SensiStep). The progress of rehabilitation will be evaluated by the primary outcome parameters maximum peak load and step duration in relation to the discharge date. Secondary outcome parameters include other spatiotemporal gait parameters in relation to discharge date. Furthermore, the gait parameters will be related to three validated clinical tests: Elderly Mobility Scale; Functional Ambulation Categories; and Visual Analogue Scale. The primary hypothesis is that participants in the intervention group will show improved and faster rehabilitation compared to the control group.
The first aim of this multicenter trial is to investigate the normal gait patterns after proximal femur fractures in the elderly. The use of biofeedback systems during rehabilitation after proximal femur fractures in the elderly is promising; therefore, the second aim is to investigate the effect of real-time visual biofeedback on gait after proximal femur fractures in the elderly. This could lead to improved outcome. In addition, analysis of the population may indicate characteristics of subgroups that benefit from feedback, making a differentiated approach in rehabilitation strategy possible.
TrialRegister.nl, NTR6794 . Registered on 31 October 2017.
股骨近端骨折是老年人低能量创伤后常见的损伤。大多数康复计划基于恢复活动能力和早期恢复负重。然而，下肢骨折患者的治疗依从性较低。此外，对于步态参数的相关性以及如何指导老年人股骨近端骨折后的康复了解甚少。因此，这项前瞻性随机对照试验的目的是深入了解步态参数，并评估实时视觉生物反馈是否能提高老年人股骨近端骨折后的治疗依从性。
这是一项双臂、平行设计、前瞻性随机对照试验。纳入标准为年龄≥60岁、低能量创伤后股骨近端骨折且负重不受限。排除标准为认知障碍和创伤前活动受限。参与者被随机分为对照组（接受常规护理）或干预组（除常规护理外，还接受关于步态中负重的实时视觉生物反馈）。每组94名参与者将使用动态生物反馈系统（SensiStep）在30米步行过程中测量时空步态参数。康复进展将通过与出院日期相关的主要结局参数最大峰值负荷和步长持续时间来评估。次要结局参数包括与出院日期相关的其他时空步态参数。此外，步态参数将与三项经过验证的临床测试相关：老年人活动量表；功能性步行分类；视觉模拟量表。主要假设是干预组的参与者与对照组相比将表现出更好、更快的康复。
这项多中心试验的首要目的是研究老年人股骨近端骨折后的正常步态模式。在老年人股骨近端骨折后的康复过程中使用生物反馈系统很有前景；因此，第二个目的是研究实时视觉生物反馈对老年人股骨近端骨折后步态的影响。这可能会改善结局。此外，对人群的分析可能会表明受益于反馈的亚组特征，从而使康复策略的差异化方法成为可能。
TrialRegister.nl，NTR6794。于2017年10月31日注册。
