Abstract
BackgroundProximal 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.MethodsThis 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.DiscussionThe 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.Trial registrationTrialRegister.nl, NTR6794. Registered on 31 October 2017.
Highlights
Proximal femur fractures are a common injury after low energy trauma in the elderly
The use of biofeedback systems during rehabilitation after proximal femur fractures in the elderly is promising; the second aim is to investigate the effect of real-time visual biofeedback on gait after proximal femur fractures in the elderly
Auditory and visual biofeedback have shown significant improvements in weight-bearing after lower extremity fractures [9, 13, 14]. These results seem promising, the effect of real-time visual biofeedback on weight-bearing during rehabilitation after proximal femur fractures in the elderly is still unknown. In this randomized controlled trial (RCT), real-time visual biofeedback will be provided to the patient and healthcare professional in the clinical setting by the ambulatory biofeedback system SensiStep (Evalan BV, Amsterdam, The Netherlands)
Summary
Study design This protocol is described according to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) Statement (see Additional file 1). Interventions Participants in the intervention group receive, in addition to the standard institutional protocol, real-time visual feedback about weight-bearing during the 30-m walk with SensiStep. Outcome measures The primary outcome measures are the gait parameters maximum peak load (in %bodyweight) and step duration (in seconds), which will be analyzed in relation to the discharge date from the rehabilitation center. Spatiotemporal gait parameters measured by the SensiStep will be correlated to the clinical test scores (e.g. EMS, FAC, and VAS). A monthly newsletter will be written by the Steering Committee and distributed among the participating centers In this newsletter, the inclusion rate will be shown per center, which is a common and effective way to increase awareness and readiness to include patients in multicenter trials. The trial progress and general results will be communicated by the Steering Committee upon request
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
