足底筋膜炎におけるインソールの効果 (Insoles)

アクティブコンパレータ：CNC-Milled EVA Insole

Participants assigned to this active-comparator arm received a custom-made ethylene-vinyl acetate (EVA) insole manufactured using computer numerical control (CNC) milling and were instructed to use the assigned orthosis for 12 weeks.

デバイス：Custom-Made CNC-Milled EVA Insole

A custom-made insole was individually manufactured from ethylene-vinyl acetate (EVA) using computer numerical control (CNC) milling. Participants used the assigned insole for 12 weeks.

実験的：FDM 3D-Printed TPU Insole

Participants assigned to this experimental arm received a custom-made thermoplastic polyurethane (TPU) insole manufactured using fused deposition modelling (FDM) three-dimensional printing and were instructed to use the assigned orthosis for 12 weeks.

デバイス：Custom-Made FDM 3D-Printed TPU Insole

A custom-made insole was individually manufactured from thermoplastic polyurethane (TPU) using fused deposition modelling (FDM) three-dimensional printing. Participants used the assigned insole for 12 weeks.

Change From Baseline in Gastrocnemius Muscle Activation During a Standardized 10-Metre Walking Task

Surface electromyography was recorded bilaterally from the gastrocnemius medialis and gastrocnemius lateralis muscles during a standardized 10-metre walking task. The processed parameters included maximum EMG envelope amplitude and mean-maximum, minimum-peak and maximum-peak activation values normalized to maximum voluntary contraction (%MVC). MVC recordings were obtained during standardized plantar-flexion and dorsiflexion tasks. Higher %MVC values indicate greater muscle activation relative to MVC. The 10-metre walk was used solely as the standardized task for EMG recording and was not evaluated as a walking-performance outcome.

Change From Baseline in Affected Foot Loading Assessed by Static Pedobarography

Static pedobarography was performed during quiet standing to quantify plantar load distribution. Rearfoot loading of the affected foot was expressed as a percentage of the total plantar load for that foot, ranging from 0% to 100%, with higher values indicating greater relative rearfoot loading. Affected and unaffected feet were coded before analysis. Because forefoot and rearfoot loading percentages are mathematically complementary, forefoot loading was not treated as a separate independent endpoint.

Change From Baseline in Foot-Related Function Assessed by the Foot Function Index

Foot-related function was evaluated using the 23-item Foot Function Index, comprising pain, disability and activity-limitation subscales. Subscale and total scores are expressed on a scale from 0 to 100, with higher scores indicating greater pain, disability or activity limitation.

Change From Baseline in Pain Intensity Assessed by the Visual Analogue Scale

Pain intensity was assessed using a 10-cm Visual Analogue Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. First-step morning pain, pain during palpation of the plantar heel and pain associated with prolonged standing were recorded and analyzed as separate pain scores.

Change From Baseline in Plantar Heel Pressure Pain Threshold

Pressure pain threshold at the plantar heel was measured using a pressure algometer and expressed in kg/cm². Higher values indicate a greater pressure pain threshold and lower pressure sensitivity.

Participant Satisfaction With the Assigned Insoles Assessed by Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST-2.0).

Participant satisfaction was assessed at Week 12 using the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0). The 12-item instrument comprises eight items evaluating satisfaction with the assistive device and four items evaluating satisfaction with related services. Each item is scored from 1 (not satisfied at all) to 5 (very satisfied). Device, service and total QUEST scores are calculated by averaging the applicable item scores, with higher scores indicating greater satisfaction. Participants also identify the three satisfaction items they consider most important; these responses were summarized descriptively.