NCT05881148

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

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

May 19, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 31, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

June 3, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2023

Completed
Last Updated

November 2, 2023

Status Verified

October 1, 2023

Enrollment Period

2 months

First QC Date

May 19, 2023

Last Update Submit

October 30, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 30m-sprint Time

    16 x30m-sprint per subject

    in a 3 hour session a day

Study Arms (2)

Carbon sprinting Super-spikes

EXPERIMENTAL

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.

Other: Carbon sprinting spiked-shoes

Standard sprinting carbon-free spiked-shoe

ACTIVE COMPARATOR
Other: Standard carbon-free sprinting spiked-shoes

Interventions

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.

Also known as: carbon super-spikes
Carbon sprinting Super-spikes

cf

Standard sprinting carbon-free spiked-shoe

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Sprinting athletes affiliated to the French Athletic Federation among the Var Athletics Comity
  • Sprint Performance \> 750pts IAAF/WA (50 to 400m)

You may not qualify if:

  • Age\<15
  • Ongoing Injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Leon Berard

Hyères, Var, 83400, France

Location

Related Publications (4)

  • 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.

    PMID: 25996964BACKGROUND
  • 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.

    PMID: 34360125BACKGROUND
  • 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.

    PMID: 29083127BACKGROUND
  • Bernuz B, Laujac S, Sirial C, Auffret S, Preda C, Slawinski J, Millot B, Pradon D, Coudrat L, Gavarry O. Effect of Advanced Footwear Technology Spikes on Sprint Acceleration: A Multiple N-of-1 Trial. Sports Med Open. 2024 Aug 30;10(1):92. doi: 10.1186/s40798-024-00758-w.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Each participant is self-blinded, but also blinded to other participants ' alternative order
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Multiple N-of-1 Trial: within-subjects repetitive blinded randomized crossovers
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Bernuz Benjamin; PMR; MD-MSc

Study Record Dates

First Submitted

May 19, 2023

First Posted

May 31, 2023

Study Start

June 3, 2023

Primary Completion

August 6, 2023

Study Completion

August 6, 2023

Last Updated

November 2, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

Data will be available upon reasonable request. For the Editorial office of the corresponding relevant editor; for meta-analyses needs, or for other detailed requests. From all types, with de-identified files (Morphometric, cinematic and FVP data, Statistical Analysis, etc..). Via a controlled access repositories, such as clinicalstudydatarequest.com, the YODA project, or Vivli.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
as soon as leading article is published
Access Criteria
cf Plan Description

Locations