## 5 Conclusions  
This pilot randomised controlled trial investigation suggests that a low-cost tactile biofeedback insole can improve patients' perception of partial weight bearing during the early, highly vulnerable post-operative rehabilitation phase after lower-limb surgery.  
Traditional self-monitoring strategies, notably the \"bathroom-scale drill\" or verbal cues provided at bedside, could not bring average load error within the clinically acceptable \(\pm 2\) kg window. In contrast, the incentiviser reduced the deviation by approximately 11 kg and enabled almost nine out of ten treated patients to comply with the surgical prescription. Accurate dosing of mechanical load is considered a key prerequisite for safe bone healing, implant protection and confident progression to full weight bearing, so even a short-term biomechanical improvement is clinically promising. The device achieves this without electronics, batteries, or wireless pairing: it is fabricated from readily available rubber insoles and four buttons, costs less than five euros per pair, and can be fitted and calibrated in under ten minutes. These characteristics make it an attractive candidate for low-resource hospitals and unsupervised home or community-based physiotherapy settings where high-tech electronic insoles remain impractical or unaffordable.  
At the same time, the present findings must be interpreted with caution. The trial was conducted at a single centre, including only 34 participants across several surgical diagnoses, and followed them only until discharge, about two weeks after the index procedure. Neither patients nor therapists could be blinded to allocation, and the control arm received usual care rather than a sham insole, leaving the possibility that part of the observed effect derives from attention or novelty. To confirm the true clinical value of the incentiviser, future work should enrol larger, diagnosis-specific cohorts, apply stratified randomisation to a visually identical sham device, blind outcome assessors, and extend follow-up to at least six months so that durability, complication rates and functional milestones can be evaluated. Pragmatic implementation studies are also warranted to quantify training requirements, patient adherence and cost-effectiveness in real-world practice.  
A.M.: methodology; IC.: data curation; F.M.: formal analysis; S.N.: project administration; R.D.: resources; M.P.: writing-review and editing; A.B.: writing-review and editing; P.A.Z.: writing--original draft. All authors have read and agreed to the published version of the manuscript.  
The APC was funded by University of Insubria.  
This study was conducted by the ethical standards outlined by the Declaration of Helsinki and approved by the University of Insubria Ethics Committee (protocol number 0026262).  
Informed Consent Statement: Informed consent was obtained from all subjects involved in the study.  
The raw data supporting the conclusions of this article will be made available by the authors on request.  
Authors [PERSON] and [PERSON] were employed by the company Private Practice. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.