Healthy AthletesPRP-Pied-PERFNCT05574322
Efficacy of a Foot Strengthening Protocol on Sport Performance Kinetics
A study testing Progressive foot strengthening protocol in people with Healthy Athletes and Healthy Volonteers, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
This randomized controlled trial aims to explore the effect of a foot strengthening protocol on toe flexion strength, foot deformation and morphology as well as kinetics during sprinting, cutting and jumping in healthy athletes (18-40 completed years). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Athletes, Healthy Volonteers
- What is being tested?
- Progressive foot strengthening protocol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 3 Feb 2023to 13 Jun 2024
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be affiliated in the federation of one of the following sports : soccer, handball, rugby, basketball or track and field;
- To practice their respective sport more than two times per week;
- Be affiliated or beneficiary of a social security insurance;
- Having freely given their written consent after having been informed of the purpose, the procedure and the potential risks involved.
- Licensed in a tennis club (FFT) and in a volleyball club (FFVolley)
Who cannot join
- Use of pharmacological therapy to match gander identity;
- Have an abnormal range of motion of the toes and/or ankle;
- Have any kind of ankle or foot pain (self-defined and self-reported by the FAAM questionnaire) in the previous 6 months;
- Have a previous injury or surgery of the lower limb in the previous 6 months;
- Have a neurological or vestibular deficit that may affect walking or balance (lumbar-sacral radiculopathy, peripheral nerve pathology, Marfan or Eehlers-Danlos syndrome, etc.);
- Have contraindication to neuromuscular electrical stimulation (pacemaker, seizure disorders, pregnancy);
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- Have a previous foot strengthening experience in the past 6 months for at least 2 weeks and more than one session per week;
- Participate at the same time in another medical interventional experiment or have participated in such a study in the 30 days preceding this study;
- Being unable to understand the purpose and conditions of the study, and to give consent;
- Being deprived of liberty or under guardianship.
Trial locations and contacts
1 site in 1 country.
About this study
This randomized controlled trial aims to explore the effect of a foot strengthening protocol on toe flexion strength, foot deformation and morphology as well as kinetics during sprinting, cutting and jumping in healthy athletes (18-40 completed years). The study consists of a 4 weeks control period, followed by 8 weeks intervention period and 4 weeks follow up
Read the detailed description
During the first period participants are unaware of their allocation, while in the intervention period they will be allocated to a train intervention or a control group (habits maintenance). The primary outcome is the toes maximal voluntary isometric plantarflexion. The treatment effectiveness estimand is the same as in a pretest-posttest case control study, considering the end of the control period as pre-point. An estimation of the individual variability in response to the treatment will be provided.
- Conditions
- Healthy Athletes, Healthy Volonteers
- Being tested
- Progressive foot strengthening protocol, Control group
- Keywords
- Foot strength, resistance training, kinetics,, sprinting, cutting, jumping, sport performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive foot strengthening protocolOther
This interventional group will perform the foot strengthening protocol (PRP) with physical tests as :
- Maximum muscle strength of the foot
- Foot muscle morphology
Control groupOther
The control group will not perform the foot strengthening protocol and will continue with all their daily activities with no change in lifestyle.
| Study group | Role | What they receive |
|---|---|---|
| Training group (PRP) | Experimental | Participants benefiting from an 8-week muscle strengthening program (PRP) Receives: Other: Progressive foot strengthening protocol |
| Control group | Sham comparator | Participants in the control group will be asked to maintain their habits and lifestyle (without training program) for the duration of the study. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximal isometric joint flexion muscle strength MTP (in N)
It will be measured using an ergometer composed of a 3-dimensional force sensor (Nano 25, ATI Industrial Automation, Garner, NC) during the 3 periods of the randomized controlled trial (control, intervention and follow-up) and repeatedly each week during the intervention protocol.
Measured: Change from baseline to Week 18
Secondary outcomes (7)
Foot deformity
It's a composite outcome :
Foot deformity will be assessed with the help of the system (Arch Height Index Measurement System, JAKTOOL Corporation, Cranberry, NJ) measuring the following variables (in cm): height of the navicular, total length of the foot, truncated length of the foot, width of the medial foot and height of the dorsal arch when the participant is sitting and then when standing on one foot.
Measured: Change from baseline to Week 18
Foot posture
Foot posture will be measured using the Foot Posture Index (FPI-6).
Measured: Change from baseline to Week 18
Morphology of the foot muscles
The morphology of the foot muscles will be evaluated by measuring with the AixPlorer Ultrasonic scanner, version 6.1.1; Supersonic Imagine, Aix-en-Provence, France.
Measured: Change from baseline to Week 18
general stiffness of the foot-ankle complex
The general stiffness of the foot-ankle complex will be evaluated using an optical measurement system (Optojump Next, Microgate, Bolzano, 113 Italy) during 6 maximal jumps with knees stretched.
Measured: Change from baseline to Week 18
propulsion impulse during sprinting
The propulsion impulse during sprinting will be evaluated using 6 force platforms embedded in the ground (Kistler, Winterhur, Switzerland) allowing to collect kinetic parameters of forces in the 3 dimensions of space at a sampling frequency of 2000 Hz.
Measured: Change from baseline to Week 18
propulsion impulse during jumps
The propulsion impulse during jumps will be evaluated using 2 force platforms embedded in the ground under each foot (Kistler, Winterhur, Switzerland) to collect kinetic force parameters in all 3 spatial dimensions during vertical and horizontal jumps at a sampling frequency of 2000 Hz.
Measured: Change from baseline to Week 18
propulsion impulse during direction changes
The propulsion impulse during direction changes will be evaluated using a ground embedded force platform (Kistler, Winterhur, Switzerland) to collect force kinetic parameters in all 3 spatial dimensions during 90° direction changes at a sampling rate of 2000 Hz.
Measured: Change from baseline to Week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start3 Feb 2023
- Primary completion14 Feb 2024
- Study completion13 Jun 2024
Why it stopped: inclusion rate too low
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AthletesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-center randomized controlled trial (RCT) in 2 parallel groups of athletic participants (18-40 years) in good general health: one receiving an 8-week muscle strengthening program (PRP group), the other not (control group) strengthening program (PRP group), the other not (control group).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal EDOUARD, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05574322
- Sponsor's protocol ID
- 21CH247
- Other IDs
- ANSM
- Acronym
- PRP-Pied-PERF
- Status last verified
- Sep 2024
- First submitted
- 3 Oct 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Foot Strengthening Protocol on Sport Performance Kinetics
- ClinicalTrials.gov ID
- NCT05574322
- Acronym / sponsor ID
- PRP-Pied-PERF / 21CH247
- Conditions
- Healthy Athletes, Healthy Volonteers
- Keywords
- Foot strength, resistance training, kinetics,, sprinting, cutting, jumping, sport performance
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inclusion rate too low
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- 14 Feb 2024 (actual)
- Study completion
- 13 Jun 2024 (actual)
- First posted
- 10 Oct 2022 (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.
This randomized controlled trial aims to explore the effect of a foot strengthening protocol on toe flexion strength, foot deformation and morphology as well as kinetics during sprinting, cutting and jumping in healthy athletes (18-40 completed years). The study consists of a 4 weeks control period, followed by 8 weeks intervention period and 4 weeks follow up
Detailed description
During the first period participants are unaware of their allocation, while in the intervention period they will be allocated to a train intervention or a control group (habits maintenance). The primary outcome is the toes maximal voluntary isometric plantarflexion. The treatment effectiveness estimand is the same as in a pretest-posttest case control study, considering the end of the control period as pre-point. An estimation of the individual variability in response to the treatment will be provided.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a single-center randomized controlled trial (RCT) in 2 parallel groups of athletic participants (18-40 years) in good general health: one receiving an 8-week muscle strengthening program (PRP group), the other not (control group) strengthening program (PRP group), the other not (control group).
| Arm | Type | Receives |
|---|---|---|
| Training group (PRP) | Experimental | Other: Progressive foot strengthening protocolParticipants benefiting from an 8-week muscle strengthening program (PRP) |
| Control group | Sham comparator | Other: Control groupParticipants in the control group will be asked to maintain their habits and lifestyle (without training program) for the duration of the study. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- To be affiliated in the federation of one of the following sports : soccer, handball, rugby, basketball or track and field;
- To practice their respective sport more than two times per week;
- Be affiliated or beneficiary of a social security insurance;
- Having freely given their written consent after having been informed of the purpose, the procedure and the potential risks involved.
- Licensed in a tennis club (FFT) and in a volleyball club (FFVolley)
Key exclusion criteria (10 listed)
- Use of pharmacological therapy to match gander identity;
- Have an abnormal range of motion of the toes and/or ankle;
- Have any kind of ankle or foot pain (self-defined and self-reported by the FAAM questionnaire) in the previous 6 months;
- Have a previous injury or surgery of the lower limb in the previous 6 months;
- Have a neurological or vestibular deficit that may affect walking or balance (lumbar-sacral radiculopathy, peripheral nerve pathology, Marfan or Eehlers-Danlos syndrome, etc.);
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 |
|---|---|---|
| Progressive foot strengthening protocolThis interventional group will perform the foot strengthening protocol (PRP) with physical tests as : * Maximum muscle strength of the foot * Foot muscle morphology | Other | Training group (PRP) |
| Control groupThe control group will not perform the foot strengthening protocol and will continue with all their daily activities with no change in lifestyle. | Other | Control group |
Primary outcome
maximal isometric joint flexion muscle strength MTP (in N)
Time frame: Change from baseline to Week 18
It will be measured using an ergometer composed of a 3-dimensional force sensor (Nano 25, ATI Industrial Automation, Garner, NC) during the 3 periods of the randomized controlled trial (control, intervention and follow-up) and repeatedly each week during the intervention protocol.
7 secondary outcomes
Foot deformity
Time frame: Change from baseline to Week 18
Foot posture
Time frame: Change from baseline to Week 18
Morphology of the foot muscles
Time frame: Change from baseline to Week 18
general stiffness of the foot-ankle complex
Time frame: Change from baseline to Week 18
propulsion impulse during sprinting
Time frame: Change from baseline to Week 18
propulsion impulse during jumps
Time frame: Change from baseline to Week 18
propulsion impulse during direction changes
Time frame: Change from baseline to Week 18
Results and safety
The study was stopped early (reason given: inclusion rate too low). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Pascal EDOUARD, PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive foot strengthening protocol in people with Healthy Athletes and Healthy Volonteers, run by Centre Hospitalier Universitaire de Saint Etienne 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 5 inclusion and 10 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: stopped early, as of the sponsor's last update on 19 Sep 2024. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: inclusion rate too low). Results are not available in the source record.
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?
maximal isometric joint flexion muscle strength MTP (in N) (time frame: Change from baseline to Week 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.