Assessment of Balance in Patients With Pes Planus
1 other identifier
interventional
40
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2022
Shorter than P25 for not_applicable
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
March 15, 2022
CompletedStudy Start
First participant enrolled
April 6, 2022
CompletedFirst Posted
Study publicly available on registry
April 11, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2022
CompletedApril 11, 2022
April 1, 2022
9 days
March 15, 2022
April 6, 2022
Conditions
Keywords
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
OTHERDetailed 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.
Interventions
Inky foot analysis to confirm the diagnosis of pes planus
Evaluation of plantar pressure distribution by pedobarography in individuals with pes planus
Evaluation of fall risk with computerized posturography
Eligibility Criteria
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: 29381041BACKGROUNDCote 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: 15902323BACKGROUNDKnapp 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: 31194317BACKGROUNDMosca 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: 21455468BACKGROUNDForriol 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: 2265808BACKGROUNDStaheli 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: 3818704BACKGROUNDAwale 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: 28482340BACKGROUNDNeri 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: 32036318BACKGROUNDSkopljak 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: 25684844BACKGROUNDAkkaya 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
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shahla Alimadatli
Istanbul University - Cerrahpasa
Central Study Contacts
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