Effects of Dynamic Balance Exercise on Flexible Pes Planus (PesPlanus)

June 24, 2023 updated by: Eylül Pınar KISA, Biruni University

Does Dynamic Balance Exercises Affect Flexible Pes Planus?

The purpose of this study is to investigate the effects of intrinsic strengthening and dynamic balance exercises in patients with flexible pes planus. Forty-five participants aged 18 to 35 years were enrolled in the study, and the first group underwent intrinsic foot muscle strengthening training with short foot exercises (SFE) and used insoles. The second group trained using the dynamic balance board, which promotes dynamic balance and used insoles. The third group used only insoles. The total duration of treatment was 8 weeks/3 days. The degree of foot deformity was assessed with the, medial longitudinal arch (MLA) angle, measurements of subtalar angle and navicular drop test. Foot position assessed using Foot Posture Index (FPI) Static balance was assessed with the Flamingo Balance Test and dynamic balance with the " BOBO Health Platform with Gaming®" device.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Pes planus (flatfoot) is generally defined as valgus of the hindfoot, disappearance of the medial longitudinal arch (MLA) in the midfoot, and supination of the forefoot relative to the hindfoot when the foot is loaded. MLA height is the most important measurement for determining the degree of pes planus. The decrease in MLA disrupts this balance and causes the muscles and bones that are supposed to balance the effect of external forces to be subjected to greater stress. As a result, the balance is affected. Conservative treatment options that can be used as the first step in treating pes planus include activity modifications, exercises, manipulations, serial cast applications, weight loss, shoes changes, shoes modifications, use of foot orthotics. Several methods are used to strengthen foot intrinsic muscles, including toe towel curls, picking up objects, shin curls, unilateral balance activities, and the short foot exercise. The common exercises are strengthening exercises defined for intrinsic muscles, "short foot exercises" (SF). It is known that arch support insoles improve foot malalignment, correct dynamic posture, effectively support leg alignment and pain relief, and normalize gait. The use of silicone insoles is a product whose range of application has increased in recent years. The extremely soft and flexible material ensures that the shape of the foot is adopted. The researchers believed that the presence of a pes planus foot deformity, common in young people, negatively affects the balance of the individual, revealing small disturbances and different balance strategies. In this situation, the training of intrinsic muscles is of great importance. The investigators aim in this study is to investigate the effects of intrinsic muscle strengthening and dynamic balance exercises performed with silicone soles in individuals with flexible pes planus.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • Turkey
      • Istanbul, Turkey
        • Biruni University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients were included in the study if they were 152° above the MLA, participants with flexible pes planus at the 1st, 2nd, and 3rd level according to Jack's test, between 18 and 35 years of age, and had not received previous treatment for pes planus.

Exclusion Criteria:

  • Individuals who had previously used orthotics, who had an orthopedic injury to the ankle, and who did not wish to participate in the study were excluded from the study.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Short Foot Exercises Group
İnsole+Short Foot Exercises group
Other: Short foot exercises, Dynamic balance exercises and insole
Short foot exercises is used to improve muscle strenght, Dynamic balance exercises is used to improve balance and insole is used to improve MLA
Experimental: Balance Exercises Group
İnsole+Balance exercises group
Other: Short foot exercises, Dynamic balance exercises and insole
Short foot exercises is used to improve muscle strenght, Dynamic balance exercises is used to improve balance and insole is used to improve MLA
Experimental: Control Group
İnsole group
Other: Short foot exercises, Dynamic balance exercises and insole
Short foot exercises is used to improve muscle strenght, Dynamic balance exercises is used to improve balance and insole is used to improve MLA

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dynamic Balance performance
Time Frame: 0-8 week
Dynamic balance was assessed using the BOBO Gaming Health Platform. With this system, which acts as a computerized strength platform, there are assessment and treatment phases. The individual was performed with the foot being tested on 2 sides of the platform. In all these evaluations, parameters related to body balance were analyzed. It gives performance scores in terms of percent.
0-8 week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Foot Posture Index Score
Time Frame: 0-8 week
Foot posture was analyzed using the Foot Posture Index. Palpation of the head of the talus in the hindfoot, inclination below and above the lateral malleolus, pronation/supination of the calcaneus, ballooning at the talonavicular joint in the forefoot, MLA structure, and abduction/adduction of the forefoot relative to the hindfoot were evaluated. Each of these criteria was assigned scores ranging from -2 to +2. The total score obtained was recorded and it indicated that the foot was in neutral position at 0, in pronation at positive values and in supination at negative values.
0-8 week
Subtalar angle
Time Frame: 0-8 week
Measurement of the subtalar angle between the Achilles tendon and the midpoint of the calcaneus was measured while the patient stood on a high platform. The pivot point was assumed to be 1 cm below the medial malleolus, and this area was marked. An angle greater than 5 degrees in the pronation or supination direction was considered abnormal.
0-8 week
Static Balance Assessment
Time Frame: 0-8 week
The patient flexed the foot behind the knee and held it with the hand in the same direction. When the patient was ready, he released the hand of the physiotherapist and at the same time the stopwatch was started. Each time the patient lost balance (touching the floor, releasing the foot), the stopwatch was stopped and restarted when the patient was ready 60 seconds. The total number of balance losses during this period was reported with number
0-8 week
Angle of Medial longitudinal Arch
Time Frame: 0-8 week
While measuring the MLA angle, a line was drawn from the center of the medial malleolus to the center of the navicular. The other line was drawn from the tuberosity of the navicular to the center of the first metatarsal head. The angle between these two lines was measured with a goniometer.
0-8 week

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biruni University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: EylÜL pINAR Kısa, Biruni University

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 14, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BirUni

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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