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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05881148
Other study ID # 2023-CS3T-Multiple N-of-1Trial
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 3, 2023
Est. completion date August 6, 2023

Study information

Verified date October 2023
Source Hôpital Léon Bérard
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Objectives : To determine intra and inter-subject sprinting performance modifications with trademarked Carbon-made spiked-Shoes (CS) compared to usual carbon-free ones (Standard spiked-Shoes-SS). Methods : Design. Multiple N-of-1 trial (Alternating Treatments Design), with block randomisation and double blind procedure. For each participants, sixteen repetitions of 30m-sprint are applied either with CS or SS, in random order for each repetition, during a 3h session a day. Blind procedures are reached by applying a dark sleeve cover on each shoes, and by separating raters from investigators. Patients. Regional to National healthy sprinting athletes (750 IAAF/WA points), affiliated to the French Athletics Federation among the South Regional Athletic League (Comité du Var-FFA), are recruited as volunteers, with their own CS (from the same brand for homogeneity and generalisation concerns) and SS. Main criteria. Time on a 30-meters sprint, with Force-Velocity Profiling (FVP) procedure, using Stalker Sport radar. Secondary outcome measures. F0, V0, Vmax, Pmax , DRP and other standard FVP parameters, also measured with MySprint software; morphometric and cinematic data ; mean price difference between the two models. Statistical analyses. A block randomisation model will be applied to check for the randoms size; variance analysis with a mixt linear model will be applied for group and confounding factors analysis. Student-T test and NAP will be applied for intra-individuals analysis.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Other:
Carbon sprinting spiked-shoes
Trademarked Carbon Spiked-Shoes, from one Trademark only to ensure generalization concerns, is used alternatively with standard carbon-free spiked-shoes, for 8 repetitions of 30m-sprint each, separated by 10 minutes rest each.
Standard carbon-free sprinting spiked-shoes
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Locations

Country Name City State
France Hopital Leon Berard Hyeres Var

Sponsors (1)

Lead Sponsor Collaborator
Hôpital Léon Bérard

Country where clinical trial is conducted

France, 

References & Publications (3)

Edouard P, Lahti J, Nagahara R, Samozino P, Navarro L, Guex K, Rossi J, Brughelli M, Mendiguchia J, Morin JB. Low Horizontal Force Production Capacity during Sprinting as a Potential Risk Factor of Hamstring Injury in Football. Int J Environ Res Public Health. 2021 Jul 23;18(15):7827. doi: 10.3390/ijerph18157827. — View Citation

Nagahara R, Kanehisa H, Fukunaga T. Influence of shoe sole bending stiffness on sprinting performance. J Sports Med Phys Fitness. 2018 Dec;58(12):1735-1740. doi: 10.23736/S0022-4707.17.07834-3. Epub 2017 Oct 27. — View Citation

Samozino P, Rabita G, Dorel S, Slawinski J, Peyrot N, Saez de Villarreal E, Morin JB. A simple method for measuring power, force, velocity properties, and mechanical effectiveness in sprint running. Scand J Med Sci Sports. 2016 Jun;26(6):648-58. doi: 10.1111/sms.12490. Epub 2015 May 21. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 30m-sprint Time 16 x30m-sprint per subject in a 3 hour session a day
See also
  Status Clinical Trial Phase
Completed NCT03306511 - Sprint Performance in Football Players With a Previous Hamstring Injury
Completed NCT04859153 - Relevant Factors on Sprint Performance in Adolescent Sprinters