Efficacy of a Foot Strengthening Protocol on Sport Performance Kinetics

NCT05574322 | Terminated

• 2 other identifiers: 21CH247ANSM
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Athletes; Healthy Volonteers

Keywords

Foot strength; resistance training; kinetics,; sprinting; cutting; jumping; sport performance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Foot deformity

  Change from baseline to Week 18

• Foot posture

  Change from baseline to Week 18

• Morphology of the foot muscles

  Change from baseline to Week 18

• general stiffness of the foot-ankle complex

  Change from baseline to Week 18

• propulsion impulse during sprinting

  Change from baseline to Week 18

Study Arms (2)

Training group (PRP)

EXPERIMENTAL

Participants benefiting from an 8-week muscle strengthening program (PRP)

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.

Other: Control group

Interventions

Progressive foot strengthening protocol OTHER

This interventional group will perform the foot strengthening protocol (PRP) with physical tests as : * Maximum muscle strength of the foot * Foot muscle morphology

Training group (PRP)

Control group OTHER

The control group will not perform the foot strengthening protocol and will continue with all their daily activities with no change in lifestyle.

Control group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Pascal EDOUARD, PhD

  Centre Hospitalier Universitaire de Saint Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 10, 2022
• Study Start: February 3, 2023
• Primary Completion: February 14, 2024
• Study Completion: June 13, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)