NCT05300620

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 29, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 20, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

8 months

First QC Date

February 28, 2022

Last Update Submit

January 30, 2024

Conditions

Healthy

Keywords

Running economyOrthotic MaterialsFootwear comfortGaitRunning

Outcome Measures

Primary Outcomes (1)

  • Change in running economy

    VO2 per bodyweight over speed, expressed in milliliters of oxygen consumed per kilogram per kilometer using CPET.

    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

Secondary Outcomes (3)

  • Change in Footwear Comfort

    16 times within the 2.5 hour session after each running bout

  • Change in running kinetics

    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

  • change in running kinematics

    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

Study Arms (4)

Original Shoe Liner

EXPERIMENTAL

This condition will be administered by inserting the original liner in the shoe and have the participants run with this shoe condition.

Device: Original Liner

Custom Foot Orthotic made out of Ethyl Vinyl Acetate material

EXPERIMENTAL

This condition will be administered by inserting a custom EVA orthotic in the shoe and have the participants run with this shoe condition.

Device: Custom Foot Orthotics EVA

Custom Foot Orthotic made of thermoplastic poly-urethane material

EXPERIMENTAL

This condition will be administered by inserting a custom TPU orthotic in the shoe and have the participants run with this shoe condition.

Device: Custom Foot Orthotics PU

Hybrid - Orthotic made of EVA and TPU material

EXPERIMENTAL

This condition will be administered by inserting a custom EVA/TPU orthotic in the shoe and have the participants run with this shoe condition.

Device: Custom Hybrid Foot Orthotics

Interventions

Custom Foot Orthotics EVADEVICE

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

Custom Foot Orthotic made out of Ethyl Vinyl Acetate material
Original LinerDEVICE

these are original shoe liners

Original Shoe Liner
Custom Foot Orthotics PUDEVICE

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

Custom Foot Orthotic made of thermoplastic poly-urethane material
Custom Hybrid Foot OrthoticsDEVICE

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

Hybrid - Orthotic made of EVA and TPU material

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Well-trained (regularly running 35 km or more a week)

You may not qualify if:

  • history of cardiovascular, neurological, or orthopaedic problems or musculoskeletal injury of the lower limb less than 3 months leading up to the data collection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aspetar

Doha, 29222, Qatar

Location

Related Publications (2)

  • Van Alsenoy K, Ryu JH, Girard O. The Effect of EVA and TPU Custom Foot Orthoses on Running Economy, Running Mechanics, and Comfort. Front Sports Act Living. 2019 Sep 19;1:34. doi: 10.3389/fspor.2019.00034. eCollection 2019.

    PMID: 33344957BACKGROUND

  • Girard O, Morin JB, Ryu JH, Van Alsenoy K. Custom foot orthoses improve performance, but do not modify the biomechanical manifestation of fatigue, during repeated treadmill sprints. Eur J Appl Physiol. 2020 Sep;120(9):2037-2045. doi: 10.1007/s00421-020-04427-0. Epub 2020 Jun 30.

    PMID: 32607818BACKGROUND

Study Officials

  • Marco Cardinale, Prof

    Aspetar Orthopeadic and Sports Medicine Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2022

First Posted

March 29, 2022

Study Start

May 20, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

January 31, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

QA(1)