Effests of Minimalist Footwear on Healthy Subjects.

NCT07452718 | Completed

• 1 other identifier: INV2025-57
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Adult Participants

Keywords

footwear; minimalist; foot core

Outcome Measures

Primary Outcomes (4)

• Intrinsic foot muscles function

  Thickness and cross-sectional area at contraction are measured

  Baseline and up to 7 months

• Intrinsic foot muscles morphology

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

  Baseline and up to 7 months

• Plantar pressure

  Plantar pressure are measured by using force platform

  Baseline and up to 7 months

• Stability

  Static and dynamic stability are measured by using force platform

  Baseline and up to 7 months

Study Arms (2)

Intervention group. Subjets who have to use minimalist footwear

EXPERIMENTAL

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

Other: Minimalist footwear (Saguaro)

Control group

NO INTERVENTION

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

Interventions

Minimalist footwear (Saguaro) OTHER

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

Intervention group. Subjets who have to use minimalist footwear

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Salamanca: lead

Study Sites (1)

Universidad de Salamanca

Salamanca, Salamanca, 37007, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Physical Therapy

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: March 5, 2026
• Study Start: April 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 12, 2025
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)