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

Primary Purpose

Pes Planus

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Short foot exercises, Dynamic balance exercises and insole
Sponsored by
Biruni University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pes Planus focused on measuring flexible pes planus, insole, balance

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Biruni University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Short Foot Exercises Group

Balance Exercises Group

Control Group

Arm Description

İnsole+Short Foot Exercises group

İnsole+Balance exercises group

İnsole group

Outcomes

Primary Outcome Measures

Dynamic Balance performance
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.

Secondary Outcome Measures

Foot Posture Index Score
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.
Subtalar angle
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.
Static Balance Assessment
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
Angle of Medial longitudinal Arch
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.

Full Information

First Posted
March 14, 2023
Last Updated
June 24, 2023
Sponsor
Biruni University
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1. Study Identification

Unique Protocol Identification Number
NCT05788406
Brief Title
Effects of Dynamic Balance Exercise on Flexible Pes Planus
Acronym
PesPlanus
Official Title
Does Dynamic Balance Exercises Affect Flexible Pes Planus?
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 14, 2023 (Actual)
Primary Completion Date
May 1, 2023 (Actual)
Study Completion Date
June 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Biruni University

4. Oversight

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

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pes Planus
Keywords
flexible pes planus, insole, balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Short Foot Exercises Group
Arm Type
Experimental
Arm Description
İnsole+Short Foot Exercises group
Arm Title
Balance Exercises Group
Arm Type
Experimental
Arm Description
İnsole+Balance exercises group
Arm Title
Control Group
Arm Type
Experimental
Arm Description
İnsole group
Intervention Type
Other
Intervention Name(s)
Short foot exercises, Dynamic balance exercises and insole
Intervention Description
Short foot exercises is used to improve muscle strenght, Dynamic balance exercises is used to improve balance and insole is used to improve MLA
Primary Outcome Measure Information:
Title
Dynamic Balance performance
Description
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.
Time Frame
0-8 week
Secondary Outcome Measure Information:
Title
Foot Posture Index Score
Description
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.
Time Frame
0-8 week
Title
Subtalar angle
Description
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.
Time Frame
0-8 week
Title
Static Balance Assessment
Description
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
Time Frame
0-8 week
Title
Angle of Medial longitudinal Arch
Description
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.
Time Frame
0-8 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
EylÜL pINAR Kısa
Organizational Affiliation
Biruni University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Biruni University
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

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Effects of Dynamic Balance Exercise on Flexible Pes Planus

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