## 4 Discussion
Furthermore, the increased peak pressure observed in the control group deserves special attention because this may reflect a worsening in the foot rollover functioning, likely due to musculoskeletal and biomechanical impairments related to DPN. Although the lack of effect on the plantar pressure distribution in our study is discouraging, an intervention program similar to ours in duration (8 weeks) and intervention modality (home-based) also did not observe any improvement in plantar pressure parameters or ankle ROM [45]. The ankle and first metatarsophalangeal (MTP) joints ROM were found to be inversely related to peak pressure and pressure-time integral to in people with diabetic neuropathy [46]. Previous studies that observed a reduction in the pressure-loading parameters after the exercise program also observed improvements in the ankle and first MTP joints ROM [16; 20; 47]. Therefore, as we did not find any improvement in the ankle and first MTP ROM, it is reasonable that we did not find more changes in pressure-loading parameters either. The results from a feasibility study originated from this FOCA-II trial have shown a significant improvement in the ROM of the hallux relative to forefoot (1 st MTP joint) and a decrease in the maximum forefoot relative to hindfoot (midfoot motion) dorsiflexion during gait in the IG [30]. However, unfortunately, the final trial results did not confirm these findings. Overall, the control group increased the hip flexor moment at heel strike compared to IG at 8 weeks and increased the hip extensor moment and knee flexor moment at push off compared to baseline, suggesting a different walking strategy after 8 and 16 weeks. People with DPN present smaller ankle and hip extensor moments at push off [48], greater hip [7] and knee flexor moments at push off, and a higher hip flexor moment at heel strike [48]. In particular, the hip flexor and knee flexor moments alterations were stressed in the control group after 8 and 16 weeks compared to the IG. The findings from the hip flexor at heel strike and extension moments at push off might suggest the existence of a hip strategy that is more optimally suited to propel the body forward at the end of the stance phase and the end of the swing phase/heel strike compared to the ankle joint [49], which has been described as less capable of dealing with the mechanical demands of walking in people with DPN [10; 50]. It seems that the exercise program preserved the gait biomechanics of IG participants for 16 weeks, preventing the worsening of their condition, as evidenced both by the gait strategy adopted and by the change in the heel peak pressure. The exercise program has some strengths that should be highlighted: (1) it was easy to implement and perform, mainly due to the short duration of the exercise session and booklet support; (2) it showed a good adherence among participants (72%), mostly because it did not require weekly visits with a physiotherapist; and (3) it provided educational content regarding DPN's deficits and self-care guidelines. Future studies should determine the sufficient and effective dose and forms of exercise to increase foot-ankle mobility and strength, improve gait biomechanical parameters, and reduce pressure-loading parameters. This study had some limitations regarding the RCT methodology; due to the nature of the study (physical therapy intervention based on exercises), it was not possible to blind the principal investigator and the participants. In addition, modality and structure of the exercise program is also a limitation: it was a relatively short intervention period for major musculoskeletal and biomechanical changes, there was limited control over the exercise intensity, and only six exercises were included in the booklet. Furthermore, performing home-based and unsupervised exercises hampered the monitoring of exercise performance, which could have influenced the musculoskeletal and biomechanical outcomes.