COMplex Fracture Orthopedic Rehabilitation (COMFORT) - Real-time visual biofeedback on weight bearing versus standard training methods in the treatment of proximal femur fractures in the elderly: study protocol for a multicenter randomized controlled trial.

BACKGROUND: 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. METHODS: 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. DISCUSSION: 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. TRIAL REGISTRATION: TrialRegister.nl, NTR6794 . Registered on 31 October 2017.

Real-time visual biofeedback to improve therapy compliance after total hip arthroplasty: A pilot randomized controlled trial.

BACKGROUND: Previous studies have shown limited therapy compliance in weight-bearing in patients following total hip arthroplasty. RESEARCH QUESTION: The purpose of this pilot RCT is to determine the immediate and late effect of real-time, visual biofeedback on weight-bearing during rehabilitation after THA in elderly. METHODS: 24 participants who underwent THA were randomized to either the control or the intervention group. The intervention group received real-time, visual biofeedback on weight-bearing during training with the physical therapist during hospitalization and at twelve weeks follow up. RESULTS: Without biofeedback, therapy compliance was limited. Significant improvement in peak load was found in the intervention group in the early postoperative phase. In contrast to the control group, the peak load at twelve weeks was significantly higher in the intervention group compared to the pre-operative peak load, indicating a lasting effect of early biofeedback. Other gait parameters were not significantly different in the early postoperative phase. In the intervention group a longer walking distance was observed and the use of walking aids was reduced at twelve weeks. SIGNIFICANCE: Biofeedback systems could be promising to improve outcomes and reduce costs in future rehabilitation programs after THA.

Real-time visual biofeedback during weight bearing improves therapy compliance in patients following lower extremity fractures.

BACKGROUND: Individuals with lower extremity fractures are often instructed on how much weight to bear on the affected extremity. Previous studies have shown limited therapy compliance in weight bearing during rehabilitation. In this study we investigated the effect of real-time visual biofeedback on weight bearing in individuals with lower extremity fractures in two conditions: full weight bearing and touch-down weight bearing. METHODS: 11 participants with full weight bearing and 12 participants with touch-down weight bearing after lower extremity fractures have been measured with an ambulatory biofeedback system. The participants first walked 15m and the biofeedback system was only used to register the weight bearing. The same protocol was then repeated with real-time visual feedback during weight bearing. The participants could thereby adapt their loading to the desired level and improve therapy compliance. RESULTS: In participants with full weight bearing, real-time visual biofeedback resulted in a significant increase in loading from 50.9±7.51% bodyweight (BW) without feedback to 63.2±6.74%BW with feedback (P=0.0016). In participants with touch-down weight bearing, the exerted lower extremity load decreased from 16.7±9.77kg without feedback to 10.27±4.56kg with feedback (P=0.0718). More important, the variance between individual steps significantly decreased after feedback (P=0.018). CONCLUSIONS: Ambulatory monitoring weight bearing after lower extremity fractures showed that therapy compliance is low, both in full and touch-down weight bearing. Real-time visual biofeedback resulted in significantly higher peak loads in full weight bearing and increased accuracy of individual steps in touch-down weight bearing. Real-time visual biofeedback therefore results in improved therapy compliance after lower extremity fractures.

Technical Aspects and Validation of a New Biofeedback System for Measuring Lower Limb Loading in the Dynamic Situation.

BACKGROUND: A variety of techniques for measuring lower limb loading exists, each with their own limitations. A new ambulatory biofeedback system was developed to overcome these limitations. In this study, we described the technical aspects and validated the accuracy of this system. METHODS: A bench press was used to validate the system in the static situation. Ten healthy volunteers were measured by the new biofeedback system and a dual-belt instrumented treadmill to validate the system in the dynamic situation. RESULTS: Bench press results showed that the sensor accurately measured peak loads up to 1000 N in the static situation. In the healthy volunteers, the load curves measured by the biofeedback system were similar to the treadmill. However, the peak loads and loading rates were lower in the biofeedback system in all participants at all speeds. CONCLUSIONS: Advanced sensor technologies used in the new biofeedback system resulted in highly accurate measurements in the static situation. The position of the sensor and the design of the biofeedback system should be optimized to improve results in the dynamic situation.