Clinical trial NCT05574322: Efficacy of a Foot Strengthening Protocol on Sport Performance Kinetics
Official title: Efficacy of a Foot Strengthening Protocol on Sport Performance Kinetics
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy Athletes
Healthy Volonteers
Keywords: Foot strength
resistance training
kinetics,
sprinting
cutting
jumping
sport performance
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: maximal isometric joint flexion muscle strength MTP (in N)
timeFrame: Change from baseline to Week 18
Secondary outcomes:
measure: Foot deformity
timeFrame: Change from baseline to Week 18
measure: Foot posture
timeFrame: Change from baseline to Week 18
measure: Morphology of the foot muscles
timeFrame: Change from baseline to Week 18
measure: general stiffness of the foot-ankle complex
timeFrame: Change from baseline to Week 18
measure: propulsion impulse during sprinting
timeFrame: Change from baseline to Week 18
measure: propulsion impulse during jumps
timeFrame: Change from baseline to Week 18
measure: propulsion impulse during direction changes
timeFrame: Change from baseline to Week 18
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: Centre Hospitalier Universitaire de Saint Etienne
name: Pascal EDOUARD, PhD
role: PRINCIPAL_INVESTIGATOR
References: