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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
Univ Med Ctr Utrecht, Dept Surg, Heidelberglaan 100, NL-3508 GA Utrecht, Netherlands.
Uppsala University, Disciplinary Domain of Science and Technology, Technology, Department of Engineering Sciences, Solid State Electronics. (Microwaves in Medical Engineering Group)
Uppsala University, Disciplinary Domain of Science and Technology, Technology, Department of Engineering Sciences, Solid State Electronics.ORCID iD: 0000-0002-2876-223X
Maastricht Univ, Med Ctr, Dept Surg, P Debyelaan 25, NL-6229 HX Maastricht, Netherlands.
2018 (English)In: Trials, ISSN 1745-6215, E-ISSN 1745-6215, Vol. 19, article id 220Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
2018. Vol. 19, article id 220
Keywords [en]
Proximal femur fracture, Weight-bearing, Biofeedback, Gait analysis, SensiStep, Fracture rehabilitation
National Category
Orthopaedics Engineering and Technology
Identifiers
URN: urn:nbn:se:uu:diva-353203DOI: 10.1186/s13063-018-2612-9ISI: 000429992800001PubMedID: 29650034OAI: oai:DiVA.org:uu-353203DiVA, id: diva2:1217447
Available from: 2018-06-13 Created: 2018-06-13 Last updated: 2019-09-17
In thesis
1. Prospective Applications of Microwaves in Medicine: Microwave Sensors for Orthopedic Monitoring and Burn Depth Assessment
Open this publication in new window or tab >>Prospective Applications of Microwaves in Medicine: Microwave Sensors for Orthopedic Monitoring and Burn Depth Assessment
2019 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

In recent years, the use of microwave techniques for medical diagnostics has experienced impressive developments. It has demonstrated excellent competencies in various modalities such as using non-ionizing electromagnetic waves, providing non-invasive diagnoses, and having the ability to penetrate human tissues within the GHz range. However, due to anatomical, physiological, and biological variations in the human body, certain obstacles are present. Moreover, there are accuracy problems such as the absence of numerical models and experimental data, difficulty in conducting tests due to safety issues with human subjects, and also practical restrictions in clinical implementation. With the presence of these issues, a better understanding of the microwave technique is essential to further improve its medical application and to introduce alternative diagnostic methods that can detect and monitor various medical conditions in real time.

The first part of this thesis focuses on measurement systems for the microwave technique in terms of sensor design and development, numerical analysis, permittivity measurement, and phantom fabrication. The aim is to investigate the feasibility of flexible systems with different fields of application including a microwave sensor system for measuring the healing progression of bone defects present in lower extremity trauma, bone regeneration in craniotomy for craniosynostosis treatments, and dielectric variation for burn injuries. The microwave sensor which utilizes the contrast in dielectric constant between various tissues was used as the primary sensor for the proposed application. This involved detailed optimization of the sensor for greater sensitivity. The experimental work carried out in the lab environment showed that the microwave sensor was able to detect the contrast in dielectric properties so that it can give an indication of the healing status for actual clinical scenarios.

The second part of the thesis is making a significant step towards its practical implementation by establishing a system that can detect and monitor the rate of healing progression with fast data acquisition speed of microseconds, and developing an efficient user interface to convert raw microwave data into legible clinical information in terms of bone healing and burn injuries. As an extension to this thesis, clinical studies were conducted and ethical approval for conducting tests on human subjects was obtained for the development of a microwave medical system. The results showed a clear difference in healing progressions due to high detection capability in terms of dielectric properties of different human tissues. All of these contributions enable a portable system to complement existing medical applications with the aim of providing more advanced healthcare systems.

Place, publisher, year, edition, pages
Uppsala: Acta Universitatis Upsaliensis, 2019. p. 96
Series
Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Science and Technology, ISSN 1651-6214 ; 1855
Keywords
Microwave sensors, split ring resonator, biomedical application, orthopedics, lower extremity injuries, craniosynostosis, burn assessment, clinical measurements, tissue dielectric properties, phantom
National Category
Other Electrical Engineering, Electronic Engineering, Information Engineering
Research subject
Engineering Science with specialization in Microwave Technology
Identifiers
urn:nbn:se:uu:diva-393105 (URN)978-91-513-0753-4 (ISBN)
Public defence
2019-11-05, Häggsalen, Ångströmlaboratoriet, Lägerhyddsvägen 1, Uppsala, 09:15 (English)
Opponent
Supervisors
Available from: 2019-10-15 Created: 2019-09-17 Last updated: 2019-11-12

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Mohd Shah, Syaiful RedzwanAugustine, Robin

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