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

Sponsor
Centre Hospitalier Universitaire de Saint Etienne (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05574322
Collaborator
(none)
72
1
2
24
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Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Other: Progressive foot strengthening protocol
  • Other: Control group
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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).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 (Participant)
Masking Description:
The RCT is divided into 3 distinct periods (see study diagram in Appendix 1): a 4-week control period, an 8-week intervention period and a 4-week follow-up period. This 3-period experimental design was designed to was designed to reduce various methodological biases
Primary Purpose:
Treatment
Official Title:
Efficacy of a Foot Strengthening Protocol on Sport Performance Kinetics
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. maximal isometric joint flexion muscle strength MTP (in N) [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.

Secondary Outcome Measures

  1. rate of development of the MTP joint bending force [Change from baseline to Week 18]

    The rate of development of the bending force of the MTP joints (in N/s) in a time range of 0 to 250 ms will be evaluated using the force sensor. (Nano 25, ATI Industrial Automation, Garner, NC)

  2. Foot deformity [Change from baseline to Week 18]

    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.

  3. Foot posture [Change from baseline to Week 18]

    Foot posture will be measured using the Foot Posture Index (FPI-6).

  4. Morphology of the foot muscles [Change from baseline to Week 18]

    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.

  5. general stiffness of the foot-ankle complex [Change from baseline to Week 18]

    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.

  6. propulsion impulse during sprinting [Change from baseline to Week 18]

    The propulsion impulse during sprinting will be evaluated using an instrumented sprinting mat (ADAL3D-WR; Medical Development, HEF Tecmachine, Andrézieux-Bouthéon, France) and 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.

  7. propulsion impulse during jumps [Change from baseline to Week 18]

    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.

  8. propulsion impulse during direction changes [Change from baseline to Week 18]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Saint-Etienne Saint-Étienne France 42055

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Saint Etienne

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT05574322
Other Study ID Numbers:
  • 21CH247
  • ANSM
First Posted:
Oct 10, 2022
Last Update Posted:
Jan 20, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne

Study Results

No Results Posted as of Jan 20, 2023