Jurgen Higher, Betty Lischke, wolf Petersen, Natalie Mengis, Daniel Niederer, Thomas Stein, Thomas Stoffels, Robert Prill, Caroline Schmidt-Lucke
Implementing evidence-based recommendations with the option of patient-individualised and situation-specific adaptations in telerehabilitation may increase adherence with improved clinical outcome.
We here present three different perspectives of the first DMD for knee rehabilitation. First, we sought to determine the usage patterns, measurement of clinical effectiveness and safety of the DMD in real-life from registry data. Next, we tested the prespecified hypothesis of its effect on clinical efficacy (adherence) and safety. Finally, we present the usage patterns and requirements of health care providers for a DMD as add-on to standard rehabilitation. All data stem from a registry-embedded hybrid design.
Materials and Methods
A registry-embedded hybrid design of DMD in rehabilitation in German-speaking countries in real life was performed. Approval was obtained by the local ethics committee prior to trial commencement (Ärztekammer Berlin, Eth-53/20). In the first part, a systematic data analysis of primary raw data of all users of a DMD-registry was conducted. This was followed by a prospective, single-blinded, patient-controlled, and formally multicentre study (part 2, “ORthelligent telematic rehabilitation System OutcoME” study, ORSOME-study, DRKS00023857) on patients after surgical intervention for knee injuries. The prespecified primary endpoint of superiority of adherence to rehabilitation was quantified from a score deducted from a beforehand validated adherence questionnaire (ADREHA-score) and compared to a similar patient control group who received standard physiotherapy. In the third part, involved health care providers were requested to provide feedback on usage, adherence, and clinical outcome in patients using the telerehabilitation.
The largest improvement of clinical outcome was seen through motivation 10.0 points [8.3–10.0], access to care 9.0 points [8.0–10.0], and athletic ambition 9.0 points [8.0–10.0] on a 10-point scale. Similarly, lack of patients’ motivation was confirmed as major risk factor by 86% of HCP for impaired clinical outcome. Greatest benefit of the DMD was seen—very similar to patients’ perception—in assessing patients’ rehabilitation status (100% of HCP), whether patients can return to work or sports (90% of HCP), optimising individual therapy schedules (81% of HCP), identifying further therapy needs (67% of HCP) and taking influence on patients’ rehabilitation.
This registry-embedded international hybrid study confirms the high potential of digital medical devices to increase the adherence to health care providers-prescribed rehabilitation after knee surgeries . The medical device may even lead to better clinical outcomes than a non-instrumented standard rehabilitation (of the same therapy amounts). These findings are in line with a broad body of evidence of the social cognitive theory engaging patients to implement agreed-upon guidelines [25–33]. Treatment adherence was positively influenced by interventions to support self-directed physical rehabilitation of patients including elements to enhance self-efficacy and self-motivation, including direct autofeedback . The sensor-based measurements are immediately visualised to the patient for guideline-recommended exercise categories to evaluate his/her training and the rehabilitation progress in a biofeedback manner.
Well-designed digital medical devices increase adherence to health care providers’ recommendations regarding rehabilitation programmes and are safe to use. Additionally, valid and reliable mobile measurement tools for quantification of complex functional movements offer substantial value for different health care provider groups. Implementing novel digital technologies may well be a key solution for functional rehabilitation protocols and programmes in the future.
We are grateful to Dr. Ana Pekanovic and Mahli Kreher for sharing their time and expertise to improve this work. We would like to thank all patients for participating in this study.
Citation: Höher J, Lischke B, Petersen W, Mengis N, Niederer D, Stein T, et al. (2023) Sensor-based telerehabilitation system increases patient adherence after knee surgery. PLOS Digit Health 2(2): e0000175. https://doi.org/10.1371/journal.pdig.0000175
Editor: Liliana Laranjo, The University of Sydney, AUSTRALIA
Received: February 21, 2022; Accepted: December 2, 2022; Published: February 17, 2023
Copyright: © 2023 Höher et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Data Availability: Researchers wishing to replicate the study can freely access the pseudonymized study data from Zenodo. The chosen data repository is hosted by CERN and complies with EU regulation (GDPR) regarding privacy and security of data.
Funding: The authors received no specific funding for this work.
Competing interests: JS, WP, NM, DN, TS, TSto and RS and are medical consultants of OPED GmbH.