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临床试验/NCT05574322
NCT05574322终止不适用

Efficacy of a Foot Strengthening Protocol on Sport Performance Kinetics

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年2月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
30
试验地点
1
主要终点
maximal isometric joint flexion muscle strength MTP (in N)

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

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

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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)

排除标准

  • •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.

研究组 & 干预措施

Training group (PRP)

Experimental

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

干预措施: Progressive foot strengthening protocol (Other)

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.

干预措施: Control group (Other)

结局指标

主要结局

maximal isometric joint flexion muscle strength MTP (in N)

时间窗: 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.

次要结局

  • Foot deformity(Change from baseline to Week 18)
  • propulsion impulse during sprinting(Change from baseline to Week 18)
  • Foot posture(Change from baseline to Week 18)
  • propulsion impulse during jumps(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 direction changes(Change from baseline to Week 18)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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