Effectiveness of Customised 3D-printed Insoles in Reducing Pain Among Frequent Park Runners

Summary

This study evaluates the effectiveness of the Zoles customised 3D-printed insoles to mitigate running-related pain among frequent recreational runners who participate in regular Park Run activities. All participants will have their feet scanned, after which half of the participants will be provided with customised 3D-printed insoles, while the other half will receive no intervention.

Conditions

• Pain

Interventions

DEVICE

Customised 3D-printed insoles

Based on measurements from the 3D scanning procedure, and factoring in individual data such as age, weight, and activity preferences, custom insoles are designed using the ZOLA software. The insoles are then 3D-printed by Zoles ApS in Espergærde (Denmark), using BCN3D printers (Barcelona, Spain) and a TPU (Thermoplastic Polyurethane) filament material from Recreus (Alicante, Spain). The printed insoles are tailored for optimal support, performance, and comfort, with varying densities for areas like the arch and heel. They are finished with an OnSteam® microfiber cover for added durability and comfort. The insoles are intended for regular insertion into participants' shoes to align with their unique biomechanical needs. (Information translated and adapted from: https://www.zoles.eu/da/processen-bag-saalerne/)

Sponsors & Collaborators

• Copenhagen University Hospital, Hvidovre

  collaborator OTHER

• Aalborg University

  collaborator OTHER

• Zoles ApS

  collaborator UNKNOWN

• St. Mary's University, Twickenham

  lead OTHER

Principal Investigators

• Filip Gertz Lysdal, MSc, PhD · Faculty of Sport, Technology and Health Sciences, St Mary's University, United Kingdom

• Suleyman Ibrahim, MEd · Faculty of Sport, Technology and Health Sciences, St Mary's University, United Kingdom

• Chris Djurtoft, PT, MSc · Department of Clinical Medicine, Aalborg University, Denmark

• Rik Mellor, MSc · Faculty of Sport, Technology and Health Sciences, St Mary's University, United Kingdom

• Kristian Thorborg, PT, MSc, PhD · Sports Orthopaedic Research Center-Copenhagen (SORC-C), Department of Orthopaedic Surgery, Copenhagen University Hospital, Amager-Hvidovre, Denmark

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

35 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-09-16

Primary Completion

2024-01-02

Completion

2024-11-25

Countries

• United Kingdom

Study Locations