Efficacy of a Foot Strengthening Protocol on Sport Performance Kinetics (PRP-Pied-PERF)

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

Study Overview

• Status: Terminated
• Conditions: Healthy Athletes; Healthy Volonteers
• Intervention / Treatment: Other: Progressive foot strengthening protocol; Other: Control group

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France, 42055
    • CHU de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Training group (PRP); Participants benefiting from an 8-week muscle strengthening program (PRP)	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
Sham Comparator: Control group; Participants in the control group will be asked to maintain their habits and lifestyle (without training program) for the duration of the study.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Foot posture	Foot posture will be measured using the Foot Posture Index (FPI-6).	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.	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.	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.	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.	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.	Change from baseline to Week 18

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Pascal EDOUARD, PhD, Centre Hospitalier Universitaire de Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2023
• Primary Completion (Actual): February 14, 2024
• Study Completion (Actual): June 13, 2024

Study Registration Dates

• First Submitted: October 3, 2022
• First Submitted That Met QC Criteria: October 6, 2022
• First Posted (Actual): October 10, 2022

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 13, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: sport performance; resistance training; sprinting; Foot strength; kinetics,; cutting; jumping
• Other Study ID Numbers: 21CH247; ANSM (Other Identifier: 2025-A01697-42)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No