NCT07167472

Brief Summary

This observational study aims to investigate the effects of different shoe heel heights on gait parameters and pelvic kinematics in healthy adults aged 18-35 years. Each participant will be assessed under three conditions: barefoot, wearing shoes with 2 cm heels, and wearing shoes with 6 cm heels. Spatiotemporal gait parameters (gait speed, cadence, step length, stance and swing phase percentages, gait cycle duration) and pelvic kinematics (tilt, obliquity, rotation symmetry) will be measured using the BTS-G wireless sensor system. The study seeks to identify biomechanical differences associated with heel height and to provide data that may contribute to shoe design and individualized rehabilitation strategies.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 11, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

7 months

First QC Date

August 26, 2025

Last Update Submit

January 8, 2026

Conditions

Outcome Measures

Primary Outcomes (8)

  • Change in Gait Speed Across Heel Height Conditions

    Self-selected walking speed (meters/second (m/s)) measured with BTS-G wireless sensor during a 10-meter walk under three conditions: barefoot, 2 cm heel, and 6 cm heel.

    At baseline session (single day, immediate assessment across three shoe conditions)

  • Change in Cadence Across Heel Height Conditions

    Step cadence (steps/min) assessed with BTS-G sensor under barefoot, 2 cm heel, and 6 cm heel conditions.

    At baseline session (single day, immediate assessment across three shoe conditions)

  • Change in Stride Length Across Heel Height Conditions

    Stride length (cm) obtained using BTS-G sensor during walking trials under barefoot, 2 cm heel, and 6 cm heel conditions.

    At baseline session (single day, immediate assessment across three shoe conditions)

  • Change in Stance and Swing Phase Percentages

    Percentage of stance (%) and swing phases (%) of the gait cycle calculated by BTS-G sensor under barefoot, 2 cm heel, and 6 cm heel conditions.

    At baseline session (single day, immediate assessment across three shoe conditions)

  • Change in Pelvic Kinematics-pelvic tilt

    Pelvic tilt recorded with BTS-G sensor across barefoot, 2 cm heel, and 6 cm heel conditions. It will be recorded as a degree.

    At baseline session (single day, immediate assessment across three shoe conditions)

  • Change in Pelvic Kinematics-pelvic obliquity

    Pelvic obliquity recorded with BTS-G sensor across barefoot, 2 cm heel, and 6 cm heel conditions. It will be recorded as a degree.

    At baseline session (single day, immediate assessment across three shoe conditions)

  • Change in Pelvic Kinematics- pelvic rotation

    Pelvic rotation recorded with BTS-G sensor across barefoot, 2 cm heel, and 6 cm heel conditions. It will be recorded as a degree.

    At baseline session (single day, immediate assessment across three shoe conditions)

  • Body Mass Index (BMI)

    ody weight and height will be measured, and BMI will be calculated as weight (kg) divided by height squared (m²). Recorded at baseline for all participants. Its unit is kg/m2.

    Baseline (single assessment before gait analysis).

Study Arms (1)

Healthy Adults with Normal BMI

Healthy volunteers aged 18-35 years with normal BMI, assessed under three walking conditions (barefoot, 2 cm heel, 6 cm heel).

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy adult volunteers aged 18-35 years with normal BMI (18.5-24.9 kg/m²) and no musculoskeletal or neurological conditions affecting gait. Participants will be assessed under three heel height conditions (barefoot, 2 cm heel, 6 cm heel) to examine the impact on gait spatiotemporal parameters and pelvic kinematics.

You may qualify if:

  • Healthy adults, aged 18-35 years
  • Body Mass Index (BMI) within normal range (18.5-24.9 kg/m²)
  • Foot structure compatible with shoe size
  • Voluntarily agrees to participate and provide informed consent.

You may not qualify if:

  • Use of orthotics or insoles
  • History of musculoskeletal conditions affecting gait
  • Lower extremity injury or surgery within the past 6 months
  • Chronic ankle instability
  • Receiving treatment related to the lower extremities within the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuksek Ihtisas University

Ankara, Turkey (Türkiye)

RECRUITING

Study Officials

  • Mıyaser Medıne Gok

    Yuksek Ihtisas University

    PRINCIPAL INVESTIGATOR
  • Busra Kalkan Balak

    Yuksek Ihtisas University

    STUDY DIRECTOR
  • Gungor Beyza Ozvar Senoz

    Yuksek Ihtisas University

    PRINCIPAL INVESTIGATOR
  • Sevılay Seda Bas

    Ankara Yildirim Beyazıt University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gungor Beyza Ozvar Senoz

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 26, 2025

First Posted

September 11, 2025

Study Start

July 1, 2025

Primary Completion

January 30, 2026

Study Completion

May 1, 2026

Last Updated

January 9, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations