Assessment of Balance in Patients With Pes Planus

April 6, 2022 updated by: Shahla ALIMADATLI, Istanbul University - Cerrahpasa (IUC)

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Adults with pes planus
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 analysis
Inky foot analysis to confirm the diagnosis of pes planus
Other Names:
  • Fall risk assessment with static posturography
Diagnostic test: Evaluation of plantar pressure with pedobarography
Evaluation of plantar pressure distribution by pedobarography in individuals with pes planus
Diagnostic test: Balance assessment with computerized posturography
Evaluation of fall risk with computerized posturography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fall risk
Time Frame: 10 minutes
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
Time Frame: 5 minutes
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plantar Pressure Analysis
Time Frame: 10 minutes

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Investigators

  • Principal Investigator: Shahla Alimadatli, Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 6, 2022

Primary Completion (Anticipated)

April 15, 2022

Study Completion (Anticipated)

May 15, 2022

Study Registration Dates

First Submitted

March 15, 2022

First Submitted That Met QC Criteria

April 6, 2022

First Posted (Actual)

April 11, 2022

Study Record Updates

Last Update Posted (Actual)

April 11, 2022

Last Update Submitted That Met QC Criteria

April 6, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstanbulUC-ShahlaALIMADATLI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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