Balance, Plantar Pressure Distribution and Gait in Pes Planus
Evaluation Of Balance, Plantar Pressure Distribution and Gait in Adults With Pes Planus
1 other identifier
interventional
108
1 country
1
Brief Summary
Introduction:The results of studies evaluating balance, plantar pressure analysis, and gait in adults with pes planus have differed in the literature. The aim of this study is to evaluate balance, plantar pressure, and gait in adults with pes planus and compare them with adults without pes planus. Materials and Methods: The study will be conducted at the Ministry of Youth and Sports, Athletic Training and Research Center. A total of 118 individuals, 59 individuals with pes planus and 59 individuals without pes planus, will be included in the study according to the Navicular Drop Test and Foot Posture Index. In the study, the descriptive characteristics of the individuals will be recorded. Static and dynamic balance measurements, plantar pressure analysis and gait analysis of individuals will be performed, and the two groups will be compared. Results: The data will be analyzed using the statistical program for social sciences (SPSS) version 21.0 (IBM SPSS Statistics for Windows, Armonk, NY: IBM Corp.). The data will be expressed as mean standard deviation (X±SD) and number (n%). The homogeneity of the groups will be evaluated with the Levene Test. Balance, plantar pressure, and walking values between the groups will be compared using the "Mann Whitney-U" Test. All the statistical analyses will be set a priori at an alpha level of p\<0.05. Discussion: The results will be discussed in the light of the recent literature. In the literature, there are conflicting results about the balance and gait of adults with pes planus. The study can contribute to the literature in this respect.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2022
Shorter than P25 for not_applicable
1 active site
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
November 20, 2021
CompletedStudy Start
First participant enrolled
February 10, 2022
CompletedFirst Posted
Study publicly available on registry
February 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2022
CompletedApril 5, 2022
April 1, 2022
2 months
November 20, 2021
April 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Static and Dynamic Balance
Balance is the ability to keep the body's center of gravity within the acceptable limits of the support surface during activities such as sitting, standing, or gait. Static and dynamic balance and stability limit values of individuals will be evaluated with the HUR Smart Balance (SME Inc, USA) balance measurement device.
10 minutes
Secondary Outcomes (7)
Plantar Pressure Analysis-weight transfer
5 minutes
Plantar Pressure Analysis- left-right foot rotation
5 minutes
Plantar Pressure Analysis- the center of gravity movement
5 minutes
Plantar Pressure Analysis- swing area
5 minutes
Gait analysis-Joint angles
5 minutes
- +2 more secondary outcomes
Study Arms (2)
Study group -adults with pes planus
ACTIVE COMPARATOR* Individuals between the ages of 20-45 * Individuals with bilateral pes planus according to the Navicular Drop Test and Foot Posture Index
Control group -adults without pes planus (normal foot)
OTHER* Individuals between the ages of 20-45 * Individuals without pes planus according to the Navicular Drop Test and Foot Posture Index
Interventions
The researchers will measure the distance between the navicular tuberosity and the ground with a caliper with non-weight bearing in sitting. After that, the distance between the ground and the navicular tuberosity will be measured in standing while weight-bearing. The researchers will evaluate both sides and record the value in mm. According to Navicular Drop Test, the difference between weighted and unweighted measurements is considered normal (neutral) if it is between 5 and 9 mm, pronation (pes planus) if it is 10 mm or more, and supination (pes cavus) if it is 4 mm or less. In our study, individuals with a difference of 10 mm or more in both feet will be included in the pes planus, and individuals with a difference between 5-9 mm will be included in the control group.
The index consists of six items in which the foot is evaluated observationally. In the evaluation, the individual is asked to stand in a comfortable and relaxed position. The researcher observes the medial longitudinal arch structure, the structure of the talonavicular joint region, the degree of abduction/adduction in the forefoot relative to the hindfoot in the front part of the foot. In the back foot, inversion/eversion of the calcaneus, talus head position, and curvatures above and below the lateral malleolus are evaluated. The total score is reached by scoring each criterion between -2 and +2 values. 0; neutral position, (+) values; pronation (pes planus), (-) values indicate supination (pes cavus). Individuals with +6 to +12 points from this index will be included in our study.
Static and dynamic balance and stability limit values of individuals will be evaluated with the HUR Smart Balance (SME Inc, USA) balance measurement device. The device consists of a computer and a platform on which individuals can place their feet. For static balance measurement, individuals will be asked to place their feet on the marked places on the platform. The researchers will evaluate the balance in four different situations, 30 seconds each. In the first test, individuals keep the balance on firm ground with their eyes open. The second test performed on the firm ground with eyes closed, in the third test, on the soft ground with eyes open, and in the fourth test, on the soft ground with eyes closed. For dynamic balance, individuals will be asked to extend their body weight to the front, back, and sides with their feet in 4 different directions for 8 seconds.
Plantar pressure analysis of individuals will be evaluated by measuring with the DIERS Pedoscan DICAM 3 v3.10.8 (2019) device. DIERS Pedoscan is a system integrated into the treadmill that measures the pressure distribution on the sole during stance. As a result of this evaluation, right-left and anterior-posterior weight transfer, left-right foot rotation, lateral mobility, the center of gravity movement, and swing area data will be recorded.
Gait analysis of individuals will be evaluated with the DIERS Leg Axis DICAM 3 v3.10.8 (2019) system. The system consists of a treadmill, computer, and cameras. Before the measurement, colored markers will be placed on the knee and ankle joints of the individual. For gait assessment, individuals will walk at their preferred comfortable walking speed. In the evaluation, joint angles, walking speed, step lengths are recorded. Evaluation time is approximately 5 minutes.
Eligibility Criteria
You may qualify if:
- Individuals between the ages of 20-45
- Individuals with bilateral pes planus according to the Navicular Drop Test and Foot Posture Index
- Individuals between the ages of 20-45
- Individuals without pes planus according to the Navicular Drop Test and Foot Posture Index
You may not qualify if:
- Individuals who had trauma, fall, injury in the last six months
- Individuals who have a chronic disease that affects gait and balance
- Individuals who have had lower extremity surgery
- Individuals who received any medical treatment during the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Baskent University
Ankara, 06790, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hasan Yasin Acar, PT
Baskent University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc. Prof.
Study Record Dates
First Submitted
November 20, 2021
First Posted
February 15, 2022
Study Start
February 10, 2022
Primary Completion
March 30, 2022
Study Completion
March 30, 2022
Last Updated
April 5, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share