search
Back to results

Assessment of Balance in Patients With Pes Planus

Primary Purpose

Pes Planus, Fall Risk

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Inky foot analysis
Evaluation of plantar pressure with pedobarography
Balance assessment with computerized posturography
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pes Planus focused on measuring Pes planus, Ink foot analysis, Pedobarography, Computed posturography

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Adults with pes planus

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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)]
    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    March 15, 2022
    Last Updated
    April 6, 2022
    Sponsor
    Istanbul University - Cerrahpasa (IUC)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05320003
    Brief Title
    Assessment of Balance in Patients With Pes Planus
    Official Title
    Assessment of Balance in Patients With Pes Planus Aged 50-65, Clinically and With Static Posturography
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 6, 2022 (Anticipated)
    Primary Completion Date
    April 15, 2022 (Anticipated)
    Study Completion Date
    May 15, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istanbul University - Cerrahpasa (IUC)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pes Planus, Fall Risk
    Keywords
    Pes planus, Ink foot analysis, Pedobarography, Computed posturography

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Adults with pes planus
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Inky foot analysis
    Other Intervention Name(s)
    Fall risk assessment with static posturography
    Intervention Description
    Inky foot analysis to confirm the diagnosis of pes planus
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Evaluation of plantar pressure with pedobarography
    Intervention Description
    Evaluation of plantar pressure distribution by pedobarography in individuals with pes planus
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Balance assessment with computerized posturography
    Intervention Description
    Evaluation of fall risk with computerized posturography
    Primary Outcome Measure Information:
    Title
    Fall risk
    Description
    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)]
    Time Frame
    10 minutes
    Title
    Fall risc
    Description
    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.
    Time Frame
    5 minutes
    Secondary Outcome Measure Information:
    Title
    Plantar Pressure Analysis
    Description
    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.
    Time Frame
    10 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shahla ALIMADATLI
    Phone
    +905378677287
    Email
    dr.shahla628@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fevziye Merih SARIDOGAN
    Phone
    +905326621700
    Email
    merihsa@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shahla Alimadatli
    Organizational Affiliation
    Istanbul University - Cerrahpasa (IUC)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29381041
    Citation
    Michaudet C, Edenfield KM, Nicolette GW, Carek PJ. Foot and Ankle Conditions: Pes Planus. FP Essent. 2018 Feb;465:18-23.
    Results Reference
    background
    PubMed Identifier
    15902323
    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.
    Results Reference
    background
    PubMed Identifier
    31194317
    Citation
    Knapp PW, Constant D. Posterior Tibial Tendon Dysfunction. 2023 May 23. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK542160/
    Results Reference
    background
    PubMed Identifier
    21455468
    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.
    Results Reference
    background
    PubMed Identifier
    2265808
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    3818704
    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.
    Results Reference
    background
    PubMed Identifier
    28482340
    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.
    Results Reference
    background
    PubMed Identifier
    32036318
    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.
    Results Reference
    background
    PubMed Identifier
    25684844
    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.
    Results Reference
    background
    PubMed Identifier
    26618068
    Citation
    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.
    Results Reference
    background

    Learn more about this trial

    Assessment of Balance in Patients With Pes Planus

    We'll reach out to this number within 24 hrs