CompletedNot Applicable

The Effect Custom Foot Orthotics on Comfort, Kinetics and Kinematics

Qatar20 participantsStarted 2022-05-20

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Well-trained (regularly running 35 km or more a week) Exclusion Criteria: * history of cardiovascular, neurological, or orthopaedic problems or musculoskeletal injury of the lower limb less than 3 months leading up to the data collection.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in running economy

Timeframe: 16 times within the 2.5 hour session during the last 2 minutes of steady state running and sprint for each of the 4 footwear conditions

Trial details

NCT IDNCT05300620

SponsorAspetar

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-31

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