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

C

Centre Hospitalier Universitaire de Saint Etienne

Status

Terminated

Conditions

Healthy Volonteers
Healthy Athletes

Treatments

Other: Progressive foot strengthening protocol
Other: Control group

Study type

Interventional

Funder types

Other

Identifiers

NCT05574322
21CH247
ANSM (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

30 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Pascal EDOUARD, PhD; Florence RANCON, CRA

Data sourced from clinicaltrials.gov

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