NCT06045208

Brief Summary

The study aims to determine and compare the effects of 8-week intrinsic foot muscle-strengthening exercises and lower extremity strengthening exercises in adolescents with pes planovalgus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
12 months until next milestone

Study Start

First participant enrolled

September 13, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2026

Completed
Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

1.3 years

First QC Date

September 13, 2023

Last Update Submit

February 20, 2026

Conditions

Keywords

exercisefoot posturefoot kinematic

Outcome Measures

Primary Outcomes (4)

  • Foot posture assesment

    Foot Posture Index 6 and navicular drop will be used for assesing the foot pronation.

    Pre-intervention assesment and after 8-week

  • Foot muscle strentgh assesment

    Toe muscle strength will be assessed through the utilization of a handheld dynamometer.

    Pre-intervention assesment and after 8-week

  • Performance and dynamic balance assesment

    Front jump test and star excursion balance test will be performed by participants.

    Pre-intervention assesment and after 8-week

  • 3D gait analysis

    The kinetic/kinematic analysis of the foot and the lower extremity will be conducted using a motion capture system, specifically employing the Oxford Foot Model and the Plug-in Gait Model.

    Pre-intervention assesment and after 8-week

Secondary Outcomes (2)

  • Functional assesment

    Pre-intervention assesment and after 8-week

  • Quality of life assesment

    Pre-intervention assesment and after 8-week

Study Arms (3)

Foot Exercise Group (FEG)

ACTIVE COMPARATOR
Other: Foot exercise

Lower Extremity Exercise Group (LEEG)

ACTIVE COMPARATOR
Other: Lower Extremity Exercise

Control Group (CG)

NO INTERVENTION

Interventions

This group will engage in an 8-week foot intrinsic strengthening training

Foot Exercise Group (FEG)

This group will engage in an 8-week lower extremity strengthening training

Lower Extremity Exercise Group (LEEG)

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age between the 12-18 years,
  • Foot posture index-6 score \> 6,
  • Navicular drop test value \> 1 cm,
  • Body mass index between 18.5 - 25 kg/m2,
  • Children with flexible pes planovalgus

You may not qualify if:

  • Presence of any pathology that prevents participation in exercises
  • Diagnosis of any neurological, psychological, or metabolic disease
  • History of orthopedic surgery
  • Use of insoles in the last 1 year
  • Leg length discrepancy and scoliosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Kultur University

Bahçelievler, Istanbul, 34188, Turkey (Türkiye)

Location

MeSH Terms

Conditions

FlatfootMotor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Halenur Evrendilek, MSc, PhD (c)

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR
  • Derya Çelik, Prof. Dr.

    Istanbul University - Cerrahpasa

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

September 13, 2023

First Posted

September 21, 2023

Study Start

September 13, 2024

Primary Completion

December 31, 2025

Study Completion

February 4, 2026

Last Updated

February 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations