Changes in the six-minute walk test and foot health status using customised foot orthoses vs sham inserts in an adult flat foot population. A pilot randomised control trial.

The presence of flexible flat feet is often reported to negatively impact foot health, and endurance during walking. Foot orthoses are commonly prescribed for symptoms associated with flat feet. This study aimed to investigate the impact of individually prescribed foot orthoses on foot health and endurance measures when used in a flat foot population.   Methods This study was a pilot parallel-group single-blinded RCT comparing customised foot orthoses and sham inserts for impact on foot pain, fatigue and function following four weeks of use, and changes in distance travelled measures (m) during the six-minute walk test following four weeks of use and at immediate wear.   Results Thirteen participants were recruited (8 female), seven received foot orthoses and six received sham inserts. The study was underpowered to detect change (range 0.05 to 0.20). A statistically significant difference existed between groups at baseline for foot pain. No statistically significant results were observed for the use of foot orthoses or sham inserts after four weeks of use or at immediate wear. The sham insert group were observed to improve their distance travelled (median increase 23.5 m), and foot pain (VAS) in accordance with minimally importance difference when compared to the foot orthoses group (between group difference 15.5 mm) following four weeks of use, however, large variations in response were observed (IQR 34.7 m and 50.5 mm respectively).   Discussion No significant differences were found between the foot orthoses and sham insert group for foot health or endurance measures following four weeks of use, however, outcomes should be viewed with caution due to small sample size and variation in individual response. Further investigations comparing customised foot orthoses and sham inserts in the adult flexible flat foot population are recommended.