The Effect Custom Foot Orthotics on Comfort, Kinetics and Kinematics

NCT05300620 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-01-31

No results posted yet for this study

Summary

The overarching aim of this project is to investigate the role of custom foot orthotics in a 'return to performance' framework as the ultimate part of the 'return to sport continuum'.

The aim of this particular study is to investigate the effect of Custom Foot Orthotics (CFO) made from different materials on Running Economy (RE).

Well trained recreational athletes (volunteers) will present to a physiology lab for a familiarisation running session where standard measurements (e.g. height, weight, shoe size, training history, foot shape) will be recorded. During this initial visit, our volunteers will also perform an incremental running test to determine the individual ventilatory threshold (VT). This will allow the use of individual speeds of a relative equal intensity that which will be used during the experimental session. A full explanation of the experimental procedures will be given and trialed. This session will last about 1 hour.

For the experimental session (minimum of one week after the incremental test and receiving the custom-made orthotics), our volunteers will report to the same lab minimal 4 hours post prandial, having done no strenuous exercise for 12 hours before data collection. After a 10-minute warm up, Participants will run four 6-minute trials (four footwear conditions) with plenty of rest (5 minutes) between running trials to recover and answer short surveys on footwear comfort and readiness to start the next session.

Also actual sprint performance will be tested. After a 10-minute general and sprint specific warm up twelve 5-second all out sprints (3 sprints per condition) with 4 minutes recovery between each sprint will be performed.

This session will last about 2 and a half hours.

The volunteers will run in four different footwear conditions:

standardized running shoes + original liner of the sport shoe standardized running shoes + a custom-made orthotic from an EVA/TPU material standardized running shoes + a custom-made orthotic from an EVA material standardized running shoes + a custom-made orthotic from an TPU material

Conditions

  • Healthy

Interventions

DEVICE

Custom Foot Orthotics EVA

these are custom foot orthotics made out of Ethyl Vinyl Acetate material

DEVICE

Original Liner

these are original shoe liners

DEVICE

Custom Foot Orthotics PU

these are custom foot orthotics made out of Expanded Poly Urethane Material

DEVICE

Custom Hybrid Foot Orthotics

these are custom foot orthotics made out of a combination of Ethyl Vinyl Acetate and Expanded Poly Urethane Material

Sponsors & Collaborators

  • Queen Margaret University

    collaborator OTHER
  • Aspetar

    lead OTHER

Principal Investigators

  • Marco Cardinale, Prof · Aspetar Orthopeadic and Sports Medicine Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-20
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Qatar

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05300620 on ClinicalTrials.gov