Effectiveness of the Fixtoe Device® in plantar pressure reduction: a preliminary study.

BACKGROUND: Metatarsalgia is a common foot condition. The metatarsophalangeal stabilizing taping technique described by Yu et al. has shown good clinical results as a provisional treatment in propulsive metatarsalgia. 35 The Fixtoe Device®, a novel orthopedic device, intends to simulate stabilizing tape. However, to date, there is no evidence of its effectiveness. The aim of this study was to assess plantar pressure changes using the Fixtoe Device®, in comparison with the traditional method (stabilizing tape) in a young, healthy sample thorough a cross-sectional study. METHODS: Maximal pressure (Kpa) and pressure-time integral (Kpa/s) in the second metatarsal head were measured in twenty-four healthy volunteers. Registers were taken in four different conditions: barefoot, traditional stabilizing tape, Fixtoe Device® without metatarsal pad, and Fixtoe Device® with metatarsal pad. RESULTS: Mean second metatarsal head maximal pressure and mean pressure-time integral showed statistical difference among the four analyzed conditions (p < 0.0001 in both cases). The improvement in maximal pressure and pressure-time integral obtained in each intervention also showed significance (p < 0.0001 in both cases). Comparing the improvement of the Fixtoe Device® with and without metatarsal pad with that of tape condition showed a moderate to high and moderate effect size for both peak pressure and pressure-time integral reduction. CONCLUSIONS: The Fixtoe Device® reduces median maximal pressure and median pressure-time integral under the second metatarsal head in healthy young individuals. The Fixtoe Device® shows higher effectiveness than the traditional second metatarsophalangeal joint stabilizing taping technique. To our knowledge, this is the first investigation proving the effectiveness of the recently developed Fixtoe Device® in terms of plantar pressure modification, which leads the way to its use in clinics.

Effect of 7-degree rearfoot varus and valgus wedging on rearfoot kinematics and kinetics during the stance phase of walking.

BACKGROUND: The scientific evidence behind the mechanical function of foot orthoses is still controversial. Research studies that have investigated the kinematic effect of foot orthoses on the lower extremity have shown variable results, with orthoses causing either no significant change or a small significant change in foot kinematics. METHODS: The right limbs of 12 healthy asymptomatic individuals were studied in three walking conditions: barefoot, with a 7 degrees rearfoot varus wedge, and with a 7 degrees rearfoot valgus wedge. Kinematic and kinetic variables measured were the foot progression angle, the peak internal tibial rotation angle, and net ankle inversion moments during the stance phase in the three conditions. RESULTS: There were statistically significant differences in the foot progression angle between the barefoot and varus wedge conditions and between the varus and valgus wedge conditions. There were no significant changes in peak internal tibial rotation among the three conditions tested. However, rearfoot varus wedges significantly reduced net ankle inversion moments compared with barefoot and rearfoot valgus wedges. CONCLUSIONS: These results support the idea that foot orthoses work by methods other than by changing kinematic parameters. The present study supports the concept that foot orthoses work primarily by altering kinetics, with their effects on kinematics being secondary.