Individually optimised rocker profiles to reduce mechanical load in patients with Achilles Tendinopathy and Plantar Fasciitis

Plantar fasciitis and Achilles tendinopathy are two of the most common types of foot injuries. Several nonsurgical
treatment options, including orthopaedic footwear are used to relieve the symptoms, which are
commonly caused by mechanical overloading. Rocker profiles (outsoles) are the most commonly prescribed
external therapeutic shoe modifications. However, the design criteria for rocker profiles have historically been
based on theoretical considerations with minimal scientific study and validation. In this study, rocker profiles
are calculated and constructed, based on a custom-made algorithm that uses individual gait parameters as
input. This innovative process needs further research to evaluate its efficacy. Therefore, the aim of this study
is to investigate the efficacy of individual optimised outsoles (rocker profiles) to reduce the mechanical
overloading for patients with plantar fasciitis and Achilles tendinopathy.

The objective of this study is to evaluate the biomechanical effect of the newly developed rocker soles aiming to reduce the mechanical load in patients suffering with Achilles tendinopathy and plantar fasciitis. A secondary objective is to evaluate use of the product and the effect of use (4 weeks) on pain and comfort.

Pre-test, after +-2 weeks Post-Test where the primary (and biomechanical secondary) endpoints will be determined. After the post-test a 4 weeks follow-up for the secondary endpoints VAS pain and VAS comfort will be determined

Participants will be fitted with individual orthopaedic shoes which are a standard shoes with a 3D-printed outsole by a certified orthotist. Shoe characteristics are calculated by a self-made algorithm based on gait parameters (measured during M1) of the participant. The non CE-marked medical device will be used as intended.