Assessment of Balance in Patients With Pes Planus

Pes Planus Clinical Trial

Official title:

Assessment of Balance in Patients With Pes Planus Aged 50-65, Clinically and With Static Posturography

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05320003
• Other study ID #: IstanbulUC-ShahlaALIMADATLI
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 6, 2022
• Est. completion date: May 15, 2022

Study information

• Verified date: April 2022
• Source: Istanbul University-Cerrahpasa
• Contact: Shahla ALIMADATLI
• Phone: +905378677287
• Email: dr.shahla628[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Materials and Methods: 34 cases with pes planus will be included in the study. Medial longitudinal arch height of all cases will be evaluated by physical examination . Affected foot, presence of "too many toes" sign will be observed. With the fingertip rise test, it will be checked whether the pes planus is flexible or rigid. Inky foot analysis and plantar pressure analysis will be performed in cases. Chippaux-Smirak index and Staheli arch index of all cases will be evaluated for the diagnosis of pes planus.The risk of falling will be calculated by evaluation of the balance with clinically and with posturography. Results: Statistical analyzes in the study will be made with the NCSS (Number Cruncher Statistical System) 2007 Statistical Software (Utah, USA) package program. In addition to descriptive statistical methods (mean, standard deviation) in the evaluation of the data, the distribution of the variables will be examined with the Shapiro - Wilk normality test, one-way analysis of variance in the comparison of the normally distributed variables, Tukey multiple comparison test in the comparison of subgroups, independent t test in the comparison of the paired groups, Chi-square test will be used in comparisons of qualitative data. Results will be evaluated at the level of significance p<0.05. Discussion: The results will be discussed according to the recent literature. In the literature, there are conflicting results about the balance and gait of adults with pes planus. In several studies in the literature, it has been found that the risk of falling is increased in elderly individuals with pes planus. The study can contribute to the literature in this perspective.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 15, 2022
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.)

Related Conditions & MeSH terms

• Fall Risk
• Flatfoot
• Pes Planus

Intervention

Diagnostic Test:
• Inky foot analysis
Inky foot analysis to confirm the diagnosis of pes planus
• Evaluation of plantar pressure with pedobarography
Evaluation of plantar pressure distribution by pedobarography in individuals with pes planus
• Balance assessment with computerized posturography
Evaluation of fall risk with computerized posturography

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University-Cerrahpasa

References & Publications (10)

Akkaya N, Doganlar N, Çelik E, Aysse SE, Akkaya S, Güngör HR, Sahin F. TEST-RETEST RELIABILITY OF TETRAX® STATIC POSTUROGRAPHY SYSTEM IN YOUNG ADULTS WITH LOW PHYSICAL ACTIVITY LEVEL. Int J Sports Phys Ther. 2015 Nov;10(6):893-900. — View Citation

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. — View Citation

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. — View Citation

Forriol F, Pascual J. Footprint analysis between three and seventeen years of age. Foot Ankle. 1990 Oct;11(2):101-4. — View Citation

Knapp PW, Constant D. Posterior Tibial Tendon Dysfunction. 2021 Jun 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. PMID: 31194317.

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Plantar Pressure Analysis	Static foot pressure measurement will be performed with (Emed, Novel GmBH,Germany); device in all cases.Peak pressure (Kpa), maximum force (N) and total foot area (cm²) values will be obtained.The correlation of these parameters with the risk of falling will be examined.	10 minutes