Trial reportBMC musculoskeletal disorders2026
Investigating plantar soft tissue elasticity modulation using air insoles during walking.
Trial report in BMC musculoskeletal disorders, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06746597 (Evaluating Mechanical Properties Change Using Optical Coherence Tomography on Plantar Skin Layers), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Evaluating Mechanical Properties Change Using Optical Coherence Tomography on Plantar Skin Layers
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Authors and funding
9 authors.
Funding
Abstract
backgroundIn the forefoot region, diabetic foot ulcer (DFU) is more likely to develop due to elevated plantar pressure and repetitive loading. This study investigated the effects of different forefoot insole pressures and walking durations on the elasticity of the plantar tissue to identify conditions that may help prevent DFU.
methodsWith thirteen healthy participants, we conducted a controlled walking exercise at a speed of 3.6 mph on a treadmill, comparing three different inner pressures of 80, 160, and 240 mmHg with two different walking durations of 10 and 20 min. We measured the elasticity of the first metatarsal head (M1) using a motor-driven indentation system with ultrasound post-walking exercise. We measured the effective Young’s modulus (E) for analysis, where E1 is taken from 5% of the initial thickness of the Toe region’s elasticity, E2 is taken from 10% of the initial thickness of the Heel region’s elasticity, and E3 is taken from 15% of the initial thickness of the Linear region’s elasticity. ANOVA and paired t-test analyses are used to find the relation between durations in the post-walking conditions.
resultsThe effect of the different insole hardnesses using ANOVA indicated that the 240 mmHg insole hardness significantly reduced the stiffness of M1 in E1 (P = 0.042) and E2 (P = 0.046), but not in E3 (P = 0.059). In the paired t-test, no significant differences were found between the 10 and 20 min walking durations for the three insole hardnesses.
conclusionThe study concluded that after a 10-minute walking duration, using 240 mmHg insole hardness has lower stiffness than the recommended stiffness range. These findings highlight the importance of optimizing insole pressure and walking duration in maintaining foot health, and provide evidence to guide the design of functional air insoles to reduce the risk of DFU formation.
trial registrationClinicalTrials.gov Identifier: NCT06746597. Registered on 2024-12-09 (retrospectively registered).
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