Sprint PerformanceCS3TNCT05881148
Carbon Sprinting Spiked-Shoes Trial
A study testing Carbon sprinting spiked-shoes and Standard carbon-free sprinting spiked-shoes in people with Sprint Performance and Carbon Spiked-shoe, run by Hôpital Léon Bérard at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sprint Performance, Carbon Spiked-shoe, Force-velocity Profile
- What is being tested?
- Carbon sprinting spiked-shoes and Standard carbon-free sprinting spiked-shoes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jun 2023to 6 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Sprinting athletes affiliated to the French Athletic Federation among the Var Athletics Comity
- Sprint Performance > 750pts IAAF/WA (50 to 400m)
Who cannot join
- Age<15
- Ongoing Injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Carbon " Super Spikes " Performances on Sprint Acceleration : Just Use it? A Multiple N-of-1 Trial. A Multiple N-of-1 Trial in Healthy Athletes
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).
Read more
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.
Read the detailed description
Setting. The medical commission of the Var Athletics Committee (VAC), composed by medicine doctors, physiotherapists, universitary sport-scientists and FFA coaches, was in charge of the project, at Toulon conurbation and Draguignan, France.
Design. N-of-1 Trials is the usual term for randomized, double-blind SCEDs. This one has been designed as an Alternating Treatment Design (ATD), one of the four SCEDs types 25.
Due to the strict " on-off " intervention effect, no potential interference was expected between phases, and a " best treatment " final phase seems not necessary in the absence of carry-over or interaction effects. After discussion with coaches and athletes, the main constraint was to respect a single day " standard " short-sprint training session (i.e commonly 5 to 15 repetitions, up to 500m total volume). Respecting these conditions and the preference of athletes, ATD method seemed the more appropriate, allowing the most cycle comparisons in the same time span.
Procedure. For each participants, sixteen repetitions (2 sets of 8) of maximal 30m-sprint are applied, on the same track, either with " carbon super-spikes " (CS) or standard spikes (SS), in random order for each repetition, during a 3h total session a day. Repetitions are preceded by a full warm-up, and followed by a cool-down phase. Rest time between sets and repetitions is standardised (20 and 8-10 minutes).
Block starting can't be choosen in order to limit bias (reaction time, adjustment…) and to allow radar records at the pelvis height (1-m high), as recommended, so that a split-stance starting position was adopted, without any starter (" as soon as ready ").
A path is created between a " polling booth " zone, and the start- and finish lines. In this blinding zone, athletes are sitted on a wheelchair, blindfolded, and putted on with their shoes, which are already covered by dark socks allowing spikes free (athletes' visual blinding). Footwear management by the investigators avoid athletes to have tactile information (athletes'somesthesic blinding). Shoes can not be seen by raters (assessors' visual blinding) or other athletes in that zone. They are then driven to the start-line with the wheelchair, in order to limit gait sensation due to important differences in foams ± air-pods between CS and SS (athletes' proprioceptive blinding). This last point was added after athletes' contribution to the method.
At the start-line, they are asked for their belief between CS or SS, so that a " doubt " rate can be assessed to check for the blind paradigm. Then the blindfold is removed, and the subject stand-up in the starting position.
After the finish-line, a 20m deceleration zone is ended by a wheelchair, where athletes are blindfolded again, shoes tooken off and bringed back to the polling booth zone, as athletes enter the rest zone.
The wind is controlled with the official WA/FFA method and anemometer. The shoes weight is assessed, and standardised, when needed, with the addition of 20g ballasts glued at the heel, so that weight difference is decreased (<50g).
Data are collected and examined by two assessors blinded from the randomisation list.
Subjects. Healthy ≥ 15 years-old athletes presenting with a 750 IAAF/World Athletics points level in sprinting (60-400m), and affiliated to the VAC, are screened with the SIFFA software (Système d'Information-FFA). Fourty-six athletes are eligible, and are contacted by email, as their coaches, for information letter. Due to homogeneity and generalisation concerns, they have to have their own or lended Nike Zoom Maxfly or Victory style. Twenty-five respond positively, and N=21 are availables for one of the half-day-proposed sessions and are included.
- Being tested
- Carbon sprinting spiked-shoes, Standard carbon-free sprinting spiked-shoes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon sprinting spiked-shoesOther
Also called carbon super-spikes
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-shoesOther
cf
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Carbon sprinting spiked-shoes |
| Standard sprinting carbon-free spiked-shoe | Active comparator | Not described Receives: Other: Standard carbon-free sprinting spiked-shoes |
What is being measured
The primary outcome is the main question the study is designed to answer.
30m-sprint Time
16 x30m-sprint per subject
Measured: in a 3 hour session a day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start3 Jun 2023
- Primary completion6 Aug 2023
- Study completion6 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sprint PerformanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Multiple N-of-1 Trial: within-subjects repetitive blinded randomized crossovers
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Léon Bérard
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin BERNUZ, MD, Hôpital Léon Bérard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881148
- Sponsor's protocol ID
- 2023-CS3T-Multiple N-of-1Trial
- Acronym
- CS3T
- Status last verified
- Oct 2023
- First submitted
- 19 May 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 25996964Edouard 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.
PubMed 34360125Nagahara 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.
PubMed 29083127Bernuz 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.
PubMed 39214886
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbon " Super Spikes " Performances on Sprint Acceleration : Just Use it? A Multiple N-of-1 Trial. A Multiple N-of-1 Trial in Healthy Athletes
- ClinicalTrials.gov ID
- NCT05881148
- Acronym / sponsor ID
- CS3T / 2023-CS3T-Multiple N-of-1Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Hôpital Léon BérardUniversity, hospital or other
- Study start
- 3 Jun 2023 (actual)
- Primary completion
- 6 Aug 2023 (actual)
- Study completion
- 6 Aug 2023 (actual)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Setting. The medical commission of the Var Athletics Committee (VAC), composed by medicine doctors, physiotherapists, universitary sport-scientists and FFA coaches, was in charge of the project, at Toulon conurbation and Draguignan, France.
Design. N-of-1 Trials is the usual term for randomized, double-blind SCEDs. This one has been designed as an Alternating Treatment Design (ATD), one of the four SCEDs types 25.
Due to the strict " on-off " intervention effect, no potential interference was expected between phases, and a " best treatment " final phase seems not necessary in the absence of carry-over or interaction effects. After discussion with coaches and athletes, the main constraint was to respect a single day " standard " short-sprint training session (i.e commonly 5 to 15 repetitions, up to 500m total volume). Respecting these conditions and the preference of athletes, ATD method seemed the more appropriate, allowing the most cycle comparisons in the same time span.
Procedure. For each participants, sixteen repetitions (2 sets of 8) of maximal 30m-sprint are applied, on the same track, either with " carbon super-spikes " (CS) or standard spikes (SS), in random order for each repetition, during a 3h total session a day. Repetitions are preceded by a full warm-up, and followed by a cool-down phase. Rest time between sets and repetitions is standardised (20 and 8-10 minutes).
Block starting can't be choosen in order to limit bias (reaction time, adjustment…) and to allow radar records at the pelvis height (1-m high), as recommended, so that a split-stance starting position was adopted, without any starter (" as soon as ready ").
A path is created between a " polling booth " zone, and the start- and finish lines. In this blinding zone, athletes are sitted on a wheelchair, blindfolded, and putted on with their shoes, which are already covered by dark socks allowing spikes free (athletes' visual blinding). Footwear management by the investigators avoid athletes to have tactile information (athletes'somesthesic blinding). Shoes can not be seen by raters (assessors' visual blinding) or other athletes in that zone. They are then driven to the start-line with the wheelchair, in order to limit gait sensation due to important differences in foams ± air-pods between CS and SS (athletes' proprioceptive blinding). This last point was added after athletes' contribution to the method.
At the start-line, they are asked for their belief between CS or SS, so that a " doubt " rate can be assessed to check for the blind paradigm. Then the blindfold is removed, and the subject stand-up in the starting position.
After the finish-line, a 20m deceleration zone is ended by a wheelchair, where athletes are blindfolded again, shoes tooken off and bringed back to the polling booth zone, as athletes enter the rest zone.
The wind is controlled with the official WA/FFA method and anemometer. The shoes weight is assessed, and standardised, when needed, with the addition of 20g ballasts glued at the heel, so that weight difference is decreased (<50g).
Data are collected and examined by two assessors blinded from the randomisation list.
Subjects. Healthy ≥ 15 years-old athletes presenting with a 750 IAAF/World Athletics points level in sprinting (60-400m), and affiliated to the VAC, are screened with the SIFFA software (Système d'Information-FFA). Fourty-six athletes are eligible, and are contacted by email, as their coaches, for information letter. Due to homogeneity and generalisation concerns, they have to have their own or lended Nike Zoom Maxfly or Victory style. Twenty-five respond positively, and N=21 are availables for one of the half-day-proposed sessions and are included.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Multiple N-of-1 Trial: within-subjects repetitive blinded randomized crossovers
| Arm | Type | Receives |
|---|---|---|
| Carbon sprinting Super-spikes | Experimental | Other: Carbon sprinting spiked-shoesTrademarked 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 sprinting carbon-free spiked-shoe | Active comparator | Other: Standard carbon-free sprinting spiked-shoes |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Sprinting athletes affiliated to the French Athletic Federation among the Var Athletics Comity
- Sprint Performance > 750pts IAAF/WA (50 to 400m)
Key exclusion criteria (2 listed)
- Age<15
- Ongoing Injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbon sprinting spiked-shoesAlso: carbon super-spikesTrademarked 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 Super-spikes |
| Standard carbon-free sprinting spiked-shoescf | Other | Standard sprinting carbon-free spiked-shoe |
Primary outcome
30m-sprint Time
Time frame: in a 3 hour session a day
16 x30m-sprint per subject
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Background: PubMed 25996964Samozino 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.
- Background: PubMed 34360125Edouard 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.
- Background: PubMed 29083127Nagahara 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.
- Derived from this study: PubMed 39214886Bernuz 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbon sprinting spiked-shoes and Standard carbon-free sprinting spiked-shoes in people with Sprint Performance and Carbon Spiked-shoe, run by Hôpital Léon Bérard at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30m-sprint Time (time frame: in a 3 hour session a day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05881148, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.