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ID
Source
Brief title
Health condition
Achilles Tendinopathy and Plantar Fasciitis
Sponsors and support
Intervention
Outcome measures
Primary outcome
Ankle dorsiflexion angle, moment and power. Peak plantar pressure of the Region of Interest (ROI).
Secondary outcome
Sagittal kinematics and kinetics of the knee (angle and moment) and hip (angle and moment); VAS pain; VAS comfort.
Background summary
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.
Study objective
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.
Study design
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
Intervention
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.
Laurens van Kouwenhove
0503612047
l.van.kouwenhove@umcg.nl
Laurens van Kouwenhove
0503612047
l.van.kouwenhove@umcg.nl
Inclusion criteria
- Diagnosed with Achilles tendinopathy and/or Plantar Fasciitis by a health care professional
- 18 years or older
Exclusion criteria
- Using additional orthopaedic devices (excluding insoles) for the lower extremity
- Self-reported other problems affecting gait
- Body weight > 130 kg
- age 60 years or older
- Shoe size > EU 46 (Male) / EU 41 (Female)
- Shoe size < EU 41 (Male) / EU 37 (Female)
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL7976 |
| Other | METC Groningen : METc 2019.326 |