Efficacy of a Foot Strengthening Protocol on Sport Performance Kinetics

NCT ID: NCT05574322

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-03

Study Completion Date

2024-06-13

Brief Summary

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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

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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

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Healthy Athletes Healthy Volonteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
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

Study Groups

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Training group (PRP)

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

Group Type EXPERIMENTAL

Progressive foot strengthening protocol

Intervention Type OTHER

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

Participants in the control group will be asked to maintain their habits and lifestyle (without training program) for the duration of the study.

Group Type SHAM_COMPARATOR

Control group

Intervention Type OTHER

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

Interventions

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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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pascal EDOUARD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Saint Etienne

Locations

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CHU de Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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ANSM

Identifier Type: OTHER

Identifier Source: secondary_id

21CH247

Identifier Type: -

Identifier Source: org_study_id

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