NCT06251804

Brief Summary

Pes planus is caused by the elongation of the intrinsic muscles in the medial arch of the foot, causing the arch to approach the ground or the sole of the foot to touch the ground completely.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

February 15, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2024

Completed
Last Updated

February 13, 2024

Status Verified

February 1, 2024

Enrollment Period

2 months

First QC Date

February 1, 2024

Last Update Submit

February 9, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Foot Posture Index

    A widely used method to assess foot posture and classify individuals according to different foot types. Each criterion is scored on a 5-point scale ranging from -2 to +2.

    6 weeks

  • Navicular Drop Test

    It is a clinical assessment used to evaluate the degree of foot pronation or flattening of the medial longitudinal arch during weight bearing. It is commonly used to assess foot pronation, especially the vertical displacement of the navicular bone during weight bearing.

    6 weeks

  • Biodex Balance System

    It is a computerized balance assessment system widely used in clinical and research settings to assess and improve balance and stability. The Biodex Balance System typically consists of a computerized platform with force sensors, visual feedback display and various training modes. It provides quantitative measurements of balance parameters, allowing accurate assessment and monitoring of progress

    6 weeks

Secondary Outcomes (1)

  • Pittsburg Sleep Index

    6 weeks

Study Arms (2)

Water exercise program

EXPERIMENTAL

The treatment program includes in-water exercise program. Participants will be exercised twice a week for six weeks.

Other: Water exercise program

Land-based-program

ACTIVE COMPARATOR

The treatment program includes land-based exercise program. Participants will be exercised twice a week for six weeks.

Other: Land-based-program

Interventions

The exercise program includes a short foot exercise and will be given in water.

Water exercise program

The exercise program includes a short foot exercise and will be given on land.

Land-based-program

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Between the ages of 18-25
  • Having bilateral pes planus
  • People with a score of 6 and above on the Foot Posture Index Score
  • Individuals with more than 10 millimeters of pronation according to the navicular drop test were included.

You may not qualify if:

  • Rigid pes planus, hallux valgus, hallux rigidus, epin calcanei
  • Lower extremity surgery
  • Neurological or orthopedic problems and history of disease
  • Regular exercise for the treatment of pes planus in the last three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahçehir University

Istanbul, Turkey (Türkiye)

Location

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

Central Study Contacts

Hazal GENÇ, PhD

CONTACT

Mustafa Emre Kıyık

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 1, 2024

First Posted

February 9, 2024

Study Start

February 15, 2024

Primary Completion

April 15, 2024

Study Completion

July 10, 2024

Last Updated

February 13, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations