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临床试验/NCT07452718
NCT07452718已完成不适用

Effects of Minimalist Footwear on Healthy Subjetcs. Randomised Controlled Trial.

University of Salamanca1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年4月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Intrinsic foot muscles function

研究概览

简要总结

Introduction:

There is evidence showing that wearing minimalist footwear offers multiple short-term advantages for the musculoskeletal system, both locally and regionally, compared to traditional footwear. However, little research has been done on the medium- and long-term effects of wearing minimalist footwear. So, the aim of the study is to assess the long-term effects of wearing minimalist footwear on various variables measured in healthy subjects.

Materials and methods:

A randomized, single-blind, controlled clinical trial is conducted. A sample of 80 healthy adults is randomly divided into an experimental group (wearing minimalist footwear) and a control group (wearing traditional footwear). The study variables are measured before and after the intervention. The outcomes are morphology and function of the intrinsic foot muscles (IFMs), study of plantar pressures under load, static and dynamic stability, thickness and compressibility of the heel fat pad, frontal plane alignment of the metatarsophalangeal joint of the hallux, and plantar skin sensitivity.

Applicability of the expected results:

If positive changes are found in the experimental group, it is proposed that educational talks or other types of actions be organized to promote the use of this type of footwear.

详细描述

Background and current situation

The concept of foot core defines the set of structures responsible for providing dynamic control to the foot; for it to function correctly, the integrity of the three subsystems that comprise it is required, which are:

  • Passive subsystem: comprises the bones, joint capsules and ligaments, including the plantar fascia, which form the plantar arch; this is defined by the medial and lateral longitudinal arches and the anterior and posterior transverse arches.
  • Active subsystem: includes the intrinsic foot muscles (IFM) and the extrinsic muscles, whose functions are to stabilise and mobilise the foot, respectively.
  • Neural subsystem: formed by all the capsuloligamentous and musculotendinous receptors of the active and passive subsystems, in addition to the plantar cutaneous receptors.

Of all the elements that make up the foot core, the importance of the IFM stands out. Some of the most relevant functions of the IFM when acting together are: adapting the position of the foot in the different phases of the gait cycle, stabilising the midfoot and forefoot, improving load absorption and force transmission capacity and controlling foot pronation. The literature has shown that morphological or functional deficits of the IFM are involved in the development of pathologies such as plantar fasciitis, hallux valgus, hammer toes, Achilles tendinopathy and chronic ankle instability.

For the foot core to function correctly, the integrity of the neural subsystem is also essential. Plantar skin sensitivity is a key element in static and dynamic body stability. It is interesting to bear this in mind when treating various pathologies that involve stability deficits and even for athletic performance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults over 18 years of age.
  • No pain in feet, ankles, or legs in the previous 3 months.
  • Healthy subjects with no musculoskeletal pathology in the lower extremities in the three months prior to the study (fractures, sprains, tendinopathies).
  • Signature of informed consent.

排除标准

  • Previous use of minimalist footwear.
  • Significant musculoskeletal deformities in the lower extremities.
  • Cognitive, neurological, visual, or vestibular disorders that may affect the outcome of any of the variables included in the study.

研究组 & 干预措施

Intervention group. Subjets who have to use minimalist footwear

Experimental

Use of minimalist footwear, 4 hours/day, during 5 months

干预措施: Minimalist footwear (Saguaro) (Other)

Control group

No Intervention

In the control group, only assessments are carried out, but there is no intervention in these subjects.

结局指标

主要结局

Intrinsic foot muscles function

时间窗: Baseline and up to 7 months

Thickness and cross-sectional area at contraction are measured

Intrinsic foot muscles morphology

时间窗: Baseline and up to 7 months

Thickness and cross-senctional area at rest are measured using ultrasound

Plantar pressure

时间窗: Baseline and up to 7 months

Plantar pressure are measured by using force platform

Stability

时间窗: Baseline and up to 7 months

Static and dynamic stability are measured by using force platform

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel García García

PhD Physical Therapy

University of Salamanca

研究点 (1)

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