Efficacy of a Foot Strengthening Protocol on Sport Performance Kinetics

Healthy Athletes Clinical Trial

— PRP-Pied-PERF  

Official title:

Efficacy of a Foot Strengthening Protocol on Sport Performance Kinetics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05574322
• Other study ID #: 21CH247
• Secondary ID: ANSM
• Status: Recruiting
• Phase: N/A
• Start date: February 3, 2023
• Est. completion date: May 2026

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Pascal EDOUARD, PhD
• Phone: (0)4 77 12 79 85
• Email: pascal.edouard[@]univ-st-etienne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). The study consists of a 4 weeks control period, followed by 8 weeks intervention period and 4 weeks follow up

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: May 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion criteria :

• 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)

Exclusion criteria :

• 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);

• 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.

Related Conditions & MeSH terms

• Healthy Athletes
• Healthy Volonteers

Intervention

Other:
• Progressive foot strengthening protocol
This interventional group will perform the foot strengthening protocol (PRP) with physical tests as : Maximum muscle strength of the foot Foot muscle morphology
• Control group
The control group will not perform the foot strengthening protocol and will continue with all their daily activities with no change in lifestyle.

Locations

Country	Name	City	State
France	CHU de Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline to Week 18
Secondary	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.	Change from baseline to Week 18
Secondary	Foot posture	Foot posture will be measured using the Foot Posture Index (FPI-6).	Change from baseline to Week 18
Secondary	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.	Change from baseline to Week 18
Secondary	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.	Change from baseline to Week 18
Secondary	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.	Change from baseline to Week 18
Secondary	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.	Change from baseline to Week 18
Secondary	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.	Change from baseline to Week 18