Summary
A $2.7 million NIH grant is fueling a collaboration between Vanderbilt University, the University of Kentucky and Moticon to revolutionize leg fracture recovery. The use of Moticon’s advanced sensor insoles allows the research team to gather real-world data on how patients load their tibia bone during daily activities, a crucial insight missing from traditional rehabilitation.
The innovation leap refers to the availability of continuous, full scope gait datasets, which allows for personalized rehabilitation plans based on real-world settings in the future. An extensive partner selection program and pilot data collection phase has been conducted throughout 2024. Moticon, besides delivering sensor insoles, contributed with a custom monitoring app and enhanced data intelligence. Patient enrollment is now open, aiming to setting new standards in orthopedic rehabilitation.
Post-injury complications impair patients quality of life and increase healthcare expenses
Fractures of the tibia or shin bone are among some of the most common types of fractures worldwide. Despite surgical interventions, nearly half of these patients are unable to resume their previous work activities a year post-injury. This significant impact on individuals’ livelihoods and the healthcare system underscores the need for improved patient monitoring and rehabilitation strategies. Recognizing this, Vanderbilt University and the University of Kentucky embarked on a collaborative research project, funded by a $2.7 million grant from the National Institutes of Health (NIH), to explore innovative solutions for enhancing recovery outcomes for tibial (lower leg) fracture patients.
Traditional rehabilitation programs are blind to musculoskeletal loading in the real-world
Traditional rehabilitation programs for tibial fractures involve prescribed exercises designed to incrementally increase load-bearing on the healing bone. However, clinicians currently lack precise tools to monitor the actual forces exerted on the tibia during a patient’s daily activities outside of clinical settings. This absence of real-time and real-world data hampers the ability to tailor rehabilitation protocols effectively, potentially leading to suboptimal recovery and prolonged disability.
Beyond merely monitoring tibial bone loading in the clinic, actionable insights from such data must extend to loading during both rehabilitation exercises and other daily activities, which serve as a starting point for individualizing rehabilitation treatment or even early intervention when needed. The challenge was to develop a non-invasive, accurate, and user-friendly system capable of monitoring these key parameters for prolonged periods in real-world environments, thereby providing meaningful guidance to both patients and healthcare providers.
A wearable technology solution to support fracture rehabilitation and improve recovery outcomes
To address this challenge, the research team turned to Moticon’s sensor insoles, renowned for their advanced technology and ease of use. These wireless, fully integrated sensor insoles are designed to capture detailed pressure and motion data without interfering with the user’s natural movements. Dr. Karl Zelik, co-principal investigator and associate professor of mechanical engineering at Vanderbilt University, emphasized the importance of this wearable technology:
“We needed a solution that seamlessly fits into patients’ everyday lives, providing continuous and reliable measurements of force under the foot. Moticon’s sensor insoles offered the best blend of technical capabilities and usability features for our study. Some of the key features for us were the multi-day battery life and storage capacity, the on-board data storage to help minimize risk of data loss, and the access to raw pressure and inertial measurement unit data. Moticon’s team also provided thoughtful feedback on our study protocol to ensure it aligned well with the insole capabilities, and they have helped us navigate and overcome challenges related to patient compliance and remote monitoring.”
The insoles are equipped with multiple sensors that monitor various parameters, including pressure distribution and force metrics. Coupled with machine learning algorithms developed at Vanderbilt, the system translates raw data into meaningful insights about the forces acting on the tibia bone during different daily activities. This integration allows for extended real-world monitoring and analysis, providing unique insight into how patients load their tibia bone during the healing process and facilitating personalized rehabilitation plans.
Moticon is also expanding its technological capabilities within this project by developing a patient-facing mobile app and enhancing long-term patient monitoring features, which help the study team. These additions will help facilitate longitudinal, real-world data collection with minimal burden and disruption to patients. Mobile app improvements could also help empower patients to actively engage in their recovery process by providing intuitive feedback on their rehabilitation progress, and monitoring to ensure they adhere to optimized treatment protocols. Furthermore, long-term remote monitoring will allow researchers and clinicians to identify trends and potential deviations, enabling timely interventions that could prevent complications and improve patient outcomes.
Dr. Brian Noehren, co-principal investigator and associate dean for research and professor in the College of Health Sciences at the University of Kentucky, highlighted the decision-making process:
“In our evaluation of commercially available technologies, Moticon’s sensor insoles stood out due to their comprehensive data collection capabilities and usability. The Moticon system provided the essential elements we needed as a research team while being a technology that could be easily incorporated into the daily routines of patients. The ability of the Moticon team to develop a patient-facing mobile app and long-term monitoring features for our project further cemented our decision to move forward with Moticon.”
Achievements of the validation phase and start of patient enrollment
The initial phases of this collaborative project focused on evaluating the insoles with healthy participants, both inside and outside of the lab, and developing a comprehensive study protocol for a 1-year remote patient monitoring study. A significant milestone was achieved with the publication of a peer-reviewed study titled “Using Fitness Tracker Data to Overcome Pressure Insole Wear Time Challenges for Remote Musculoskeletal Monitoring” in the journal Sensors. This research demonstrated that wrist-worn fitness trackers, when combined with pressure-sensing insoles, could effectively estimate tibial loading in real-world settings. The study emphasized the need for comprehensive data collected with sensor insoles in order to develop models that accurately supplemented insole data with continuous fitness tracker inputs. This enabled monitoring of bone loading across a full day and even when shoes (and insoles) were only worn for a portion of the day.
Building upon these promising results, the project is transitioning to the remote patient monitoring phase. Patient enrollment is now underway at the University of Kentucky Healthcare Orthopaedic clinic. This phase aims to monitor tibial loading in patients recovering from fractures, utilizing Moticon’s sensor insoles and the newly developed patient-facing mobile app. The integration of these tools is expected to provide both patients and clinicians with first-of-its-kind data on tibial bone load and recovery after surgery, which could facilitate personalized rehabilitation strategies and potentially improve recovery outcomes.
Dr. Zelik expressed optimism about the forthcoming clinical phase:
“Transitioning from healthy participants to real patients, and from lab pilots to longitudinal studies, marks a pivotal step in our research. We anticipate that the insights gained from continuous, real-world monitoring will enable us to refine rehabilitation protocols and better understand bone healing, ultimately enhancing patient care and recovery trajectories.”
The collaboration between Vanderbilt University, the University of Kentucky, and Moticon continues to exemplify the potential of integrating advanced wearable technology into clinical practice, aiming to set new standards in orthopedic rehabilitation.
Disclaimer
The mention of commercial products, their sources, or their use in connection with material reported herein is not to be construed as either an actual or implied endorsement of such products by Vanderbilt University or the University of Kentucky.
Afore listed article was authorized on February 19, 2025. The following information is provided by Moticon and is not part of the authorized article.
Tips and Solutions for Long-Term Gait Monitoring
The study presented in this story includes features for collecting biomechanical data over a longer period of time, using an in-shoe measurement system. While the method offers data highly significant for assessing musculoskeletal loading patterns in the real world, several aspects of uncontrolled data acquisition should be considered. Further reading provides a guideline for designing clinical studies that include patient monitoring in real life.
Moticon is offering a unique range of product features for monitoring patients’ gait under real life conditions. The following table highlights key features of Moticon’s monitoring solutions.
| Product Feature | Type | Description |
|---|---|---|
| Smart Monitoring | Sensor Insole + Firmware | Extends total standalone recording time: special on-board recording mode which automatically pauses data recording when patients are inactive and resumes upon phases of activity |
| Data Buffering | Firmware | Increases robustness against data loss: intermediately stores sensor data in non-volatile memory (NVM) during monitoring. |
| Auto Zeroing | Firmware | Increases total force data validity: continously performs pressure sensor zeroing in offloading phases to keep sensor zero levels perfectly aligned. |
| Telemetry App | Mobile App | Increases compliance and reduces probability of dropouts: small app running in background of patient’s phone and transmitting basic usage and sanity data. |
| Shipping Mode | Firmware | Safes battery capacity: automated deep shutdown of sensor insoles’ system functions during transportation. Important in cases when patients receive their equipment by mail. |
Sources
(1) Nurse C. A., et al. 2024. Using Fitness Tracker Data to Overcome Pressure Insole Wear Time Challenges for Remote Musculoskeletal Monitoring. Sensors. DOI: https://doi.org/10.3390/s24237717
(2) Cramer L. A., et al. 2022. Validity and Reliability of the Insole3 Instrumented Shoe Insole for Ground Reaction Force Measurement during Walking and Running. Sensors. DOI: https://doi.org/10.3390/s22062203
