NCT05320003

Brief Summary

Introduction: Pes planus is a foot deformity with increased contact of the foot with the ground as a result of the decrease or disappearance of the medial longitudinal arch of the foot. The arch of the foot creates an adaptive and flexible support for the whole body, and biomechanical changes in the foot can affect the whole body posture and balance. The results of the studies evaluating balance and plantar pressure analysis in adults with pes planus seem contradictory. The aim of this study is to evaluate fall risk and plantar pressure in adults with pes planus aged 50 -65 years

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Status
unknown

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

March 15, 2022

Completed
22 days until next milestone

Study Start

First participant enrolled

April 6, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2022

Completed
Last Updated

April 11, 2022

Status Verified

April 1, 2022

Enrollment Period

9 days

First QC Date

March 15, 2022

Last Update Submit

April 6, 2022

Conditions

Keywords

Pes planusInk foot analysisPedobarographyComputed posturography

Outcome Measures

Primary Outcomes (2)

  • Fall risk

    Balance - the body's ability to remain stable against internal and external factors.Clinical, Functional and computer aided methods are frequently used to evaluate balance. The risk of falling will be evaluated with the computerized static posturography device \[Tetrax® Interactive Postural Balance System (Sunlight Medical, Israel)\]

    10 minutes

  • Fall risc

    Balance - the body's ability to remain stable against internal and external factors.Clinical, Functional and computer aided methods are frequently used to evaluate balance. The risk of falling will be evaluated with the timed up to go test.

    5 minutes

Secondary Outcomes (1)

  • Plantar Pressure Analysis

    10 minutes

Study Arms (1)

Adults with pes planus

OTHER

Detailed clinical examination of cases with pes planus will be performed. Inky foot analysis of both feet will be performed to confirm the diagnosis of pes planus in the subjects included in the study. Staheli arch index and Chippaux-Smirak Index will be calculated for each foot based on the footprints obtained. According to the Staheli Arc Index 1 and above, according to the Chippaux-Smirak Index 0.45 and above will be considered as pes planus, static foot pressure measurement will be performed with a pedobarography device in all cases. Peak pressure, maximum force and total foot area values will be obtained. Balance assessment of the patients will be performed with a computerized static posturography device. Individuals will be graded according to the fall index results, as low, medium and high risk. It will be determined whether there is a fall risk with the Timed Up and Go Test, which is one of the clinical balance tests.

Diagnostic Test: Inky foot analysisDiagnostic Test: Evaluation of plantar pressure with pedobarographyDiagnostic Test: Balance assessment with computerized posturography

Interventions

Inky foot analysisDIAGNOSTIC_TEST

Inky foot analysis to confirm the diagnosis of pes planus

Also known as: Fall risk assessment with static posturography
Adults with pes planus

Evaluation of plantar pressure distribution by pedobarography in individuals with pes planus

Adults with pes planus

Evaluation of fall risk with computerized posturography

Adults with pes planus

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 50 years and above with pes planus according to Staheli Arch Index and Chippaux- Smirak Index

You may not qualify if:

  • Congenital anomalies of the foot
  • Prior lower extremity surgery Inflammatory arthritis
  • Neuromuscular diseases
  • Diseases that interfere with lower extremity circulation
  • Presence of orthostatic hypotension
  • Untreated visual impairment
  • Neurological and vestibular diseases
  • Use of drugs that can cause balance disorders (Antipsychotics, Pregabalin, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Michaudet C, Edenfield KM, Nicolette GW, Carek PJ. Foot and Ankle Conditions: Pes Planus. FP Essent. 2018 Feb;465:18-23.

    PMID: 29381041BACKGROUND
  • Cote KP, Brunet ME, Gansneder BM, Shultz SJ. Effects of Pronated and Supinated Foot Postures on Static and Dynamic Postural Stability. J Athl Train. 2005 Mar;40(1):41-46.

    PMID: 15902323BACKGROUND
  • Knapp PW, Constant D. Posterior Tibial Tendon Dysfunction. 2024 May 21. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK542160/

    PMID: 31194317BACKGROUND
  • Mosca VS. Flexible flatfoot in children and adolescents. J Child Orthop. 2010 Apr;4(2):107-21. doi: 10.1007/s11832-010-0239-9. Epub 2010 Feb 18.

    PMID: 21455468BACKGROUND
  • Forriol F, Pascual J. Footprint analysis between three and seventeen years of age. Foot Ankle. 1990 Oct;11(2):101-4. doi: 10.1177/107110079001100208.

    PMID: 2265808BACKGROUND
  • Staheli LT, Chew DE, Corbett M. The longitudinal arch. A survey of eight hundred and eighty-two feet in normal children and adults. J Bone Joint Surg Am. 1987 Mar;69(3):426-8.

    PMID: 3818704BACKGROUND
  • Awale A, Hagedorn TJ, Dufour AB, Menz HB, Casey VA, Hannan MT. Foot Function, Foot Pain, and Falls in Older Adults: The Framingham Foot Study. Gerontology. 2017;63(4):318-324. doi: 10.1159/000475710. Epub 2017 May 9.

    PMID: 28482340BACKGROUND
  • Neri SGR, Harvey LA, Tiedemann A, Gadelha AB, Lima RM. Obesity and falls in older women: Mediating effects of muscle quality, foot loads and postural control. Gait Posture. 2020 Mar;77:138-143. doi: 10.1016/j.gaitpost.2020.01.025. Epub 2020 Feb 1.

    PMID: 32036318BACKGROUND
  • Skopljak A, Muftic M, Sukalo A, Masic I, Zunic L. Pedobarography in diagnosis and clinical application. Acta Inform Med. 2014 Dec;22(6):374-8. doi: 10.5455/aim.2014.22.374-378. Epub 2014 Dec 19.

    PMID: 25684844BACKGROUND
  • Akkaya N, Doganlar N, Celik E, Aysse SE, Akkaya S, Gungor HR, Sahin F. TEST-RETEST RELIABILITY OF TETRAX(R) STATIC POSTUROGRAPHY SYSTEM IN YOUNG ADULTS WITH LOW PHYSICAL ACTIVITY LEVEL. Int J Sports Phys Ther. 2015 Nov;10(6):893-900.

    PMID: 26618068BACKGROUND

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

  • Shahla Alimadatli

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shahla ALIMADATLI

CONTACT

Fevziye Merih SARIDOGAN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 15, 2022

First Posted

April 11, 2022

Study Start

April 6, 2022

Primary Completion

April 15, 2022

Study Completion

May 15, 2022

Last Updated

April 11, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share