NCT07155577

Brief Summary

This study aims to investigate the effects of pes planus deformity on gait spatiotemporal parameters and pelvic kinematics during walking on different inclines. Participants will include healthy adults aged 18-35 years with flexible bilateral pes planus and normal body mass index. Pes planus severity will be evaluated using the Jack's toe-raise test and the navicular drop test. Gait parameters such as walking speed, cadence, stride length, stance and swing phase percentages, gait cycle duration, as well as pelvic tilt, obliquity, and rotation symmetry will be measured using the BTS-G wireless sensor system. Assessments will be performed on both flat and inclined treadmill conditions. The findings are expected to provide new insights into the biomechanical adaptations of pes planus during walking and contribute to the development of an individualized rehabilitation protocol.

Trial Health

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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 27, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 4, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 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 27, 2025

Last Update Submit

January 8, 2026

Conditions

Outcome Measures

Primary Outcomes (7)

  • Gait Speed (Level vs. Inclined Walking)

    Self-selected walking speed (m/s) measured during 20-m trials under level and inclined treadmill conditions using the BTS-G wireless sensor (L4-L5 placement). Between-group (pes planus vs control) and within-condition comparisons.

    up to 6 months

  • Cadence

    Steps per minute captured by BTS-G during level and inclined walking; between-group and within-condition comparisons.Unit of Measure: steps/min.

    up to 6 months

  • Stride Length

    Stride length (cm) during level and inclined walking recorded via BTS-G; between-group and within-condition comparisons.

    up to 6 months

  • Stance and Swing Phase Percentages

    Percentage of the gait cycle spent in stance and swing (%) under level and inclined conditions using BTS-G; between-group and within-condition comparisons.

    up to 6 months

  • 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.

    up to 6 months

  • 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.

    up to 6 months

  • 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.

    up to 6 months

Secondary Outcomes (2)

  • Navicular Drop (Severity of Pes Planus)

    Baseline (prior to treadmill assessments)

  • BMI (Body Mass Index)

    Baseline (prior to treadmill assessments)

Study Arms (2)

Flexible Pes Planus Group

Adults aged 18-35 years with bilateral flexible pes planus, confirmed by Jack's toe-raise test and navicular drop ≥10 mm

Healthy Control Group

Adults aged 18-35 years with normal BMI and no pes planus deformity.

Eligibility Criteria

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

Adults aged 18-35 years with normal body mass index will be recruited. The study will include two groups: Flexible Pes Planus Group: Participants with bilateral, asymptomatic, flexible pes planus confirmed by Jack's toe-raise test and a navicular drop ≥10 mm. Healthy Control Group: Participants without pes planus deformity and with normal foot posture.

You may qualify if:

  • Age 18-35 years
  • Normal BMI
  • Bilateral, asymptomatic flexible pes planus
  • Navicular drop ≥10 mm (both feet)
  • Willing and able to provide informed consent and complete the procedure.
  • \*\*Healthy Control Group
  • Age 18-35 years
  • Normal BMI
  • No pes planus deformity; otherwise healthy and able to complete procedures

You may not qualify if:

  • Use of orthotics/insoles
  • Musculoskeletal disorders affecting gait (other than pes planus in the case group)
  • Lower extremity injury or surgery within the last 6 months
  • Chronic ankle instability
  • Any treatment related to the lower extremity/pes planus within the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuksek Ihtisas University

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Aybuke Ertugrul

    Yuksek Ihtisas University

    PRINCIPAL INVESTIGATOR
  • Elıf Ceren Ersoy

    Yuksek Ihtisas University

    PRINCIPAL INVESTIGATOR
  • Busra Kalkan Balak

    Yuksek Ihtisas University

    STUDY DIRECTOR
  • Zehranur Dağasar

    Yuksek Ihtisas University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gungor Beyza Ozvar Senoz

CONTACT

Study Design

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

Study Record Dates

First Submitted

August 27, 2025

First Posted

September 4, 2025

Study Start

July 1, 2025

Primary Completion

January 25, 2026

Study Completion

May 1, 2026

Last Updated

January 9, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations