Smart Offloading Boot System for Remote Patient Monitoring: Toward Adherence Reinforcement and Proper Physical Activity Prescription for Diabetic Foot Ulcer Patients

Authors

Catherine Park
Ramkinker Mishra
Davide Vigano
Maurizio Macagno
Stefano Rossotti
Karen D'Huyvetter
Jason Garcia
David G Armstrong
Bijan Najafi

Publication Date

1-1-2023

Journal

Journal of Diabetes Science and Technology

DOI

10.1177/19322968211070850

PMID

35048739

PMCID

PMC9846414

PubMedCentral® Posted Date

1-20-2022

PubMedCentral® Full Text Version

Post-print

Published Open-Access

yes

Keywords

Humans, Female, Male, Diabetic Foot, Exercise, Walking, Gait, Monitoring, Physiologic, Shoes, Diabetes Mellitus, smart offloading boot, diabetic foot ulcer, adherence, remote monitoring, mobile health

Abstract

Background: A critical factor in healing diabetic foot ulcers is patient adherence to offloading devices. We tested a smart offloading boot (SmartBoot) combined with a smartwatch app and cloud dashboard to remotely monitor patient adherence and activity. In addition, the impact of SmartBoot on balance, gait, and user experience was investigated.

Methods: Fourteen volunteers (31.6±8.7 years; 64% female) performed natural activities (eg, sitting, standing, walking) with and without the SmartBoot for approximately 30 minutes. All participants completed balance tests, 10-meter walking tests at slow, normal, and fast pace while wearing the SmartBoot, and a user experience questionnaire. The accuracy of real-time adherence reporting was assessed by comparing the SmartBoot and staff observation. Center of mass (COM) sway and step counts were measured using a validated wearable system.

Results: Average sensitivity, specificity, and accuracy for adherence and non-adherence were 90.6%, 88.0%, and 89.3%, respectively. The COM sway area was significantly smaller with the SmartBoot than without the SmartBoot regardless of test condition. Step count error was 4.4% for slow waking, 36.2% for normal walking, 16.0% for fast walking. Most participants agreed that the SmartBoot is easy to use, relatively comfortable, nonintrusive, and innovative.

Conclusions: To our knowledge, this is the first smart offloading system that enables remote patient monitoring and real-time adherence and activity reporting. The SmartBoot enhanced balance performance, likely due to somatosensory feedback. Questionnaire results highlight SmartBoot's technical and clinical potential. Future studies warrant clinical validation of real-time non-adherence alerting to improve wound healing outcomes in people with diabetic foot ulcers.