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Effect of Different Exercise Approaches on Balance and Proprioception in Individuals With Pes Planus

Primary Purpose

Pes Planus

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Mobility and Stability Exercise
Stretching Exercise
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pes Planus focused on measuring Exercise, Stability exercises, Mobility exercises, Stretching exercises

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Having mild and moderate pes planus,
  • Volunteering of individuals,
  • Being between the age group of 18-40,
  • Having experienced at least one inflammatory symptom (pain, swelling, etc.)
  • Not having any systemic, locomotor and foot related diseases, sensory loss, diabetic and peripheral neuropathy.

Exclusion Criteria:

  • Having had a serious lower extremity injury in the last 6 months,
  • Getting a full score from the balance test,
  • Having ligament rupture in the ankle.

Sites / Locations

  • Medipol hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mobility and Stability Exercise

Stretching Exercise

Arm Description

The patients were divided into two groups. Exercises were applied to both groups for 4 weeks.

The patients were divided into two groups. Exercises were applied to both groups for 4 weeks.

Outcomes

Primary Outcome Measures

Star Excursion Balance Test
It is used to measure dynamic postural balance. The test is based on the ability to reach the farthest possible distance on the supporting leg in 8 different directions. The person reaches as far as he can reach with his foot and touches the strip lightly with the tip of his toe. Then it returns to the starting position. Then the other line is passed and a total of 8 lines are completed in this way. After the whole process is repeated 3 times with the right foot, the left foot is changed and it is repeated 3 times. The participant records the distances reached at the end of the test. We have 16 scores left for 8 right and 8 left feet in total. Reach (%) = Reach distance / Leg length x 100
Range of Motion Measurement
Dorsiflexion, plantar flexion, inversion and eversion ranges of motion of the ankle joints of individuals are actively measured using a universal goniometer and recorded in degrees.
Berg Balance Test
Berg Balance Test It consists of 14 general balance activities that change the orientation of the body's center of gravity with respect to the support surface and evaluate the ability to maintain a static position while decreasing on the support surface. During the activities, the patient is evaluated by the observer, and the score for each activity is determined, ranging from 0 to 4. The highest score corresponds to the ability to complete the activity quickly and easily. The highest overall score is 56 and reflects a perfect balance function. The closer the score is from 56 to 36, the greater the risk of falling. It is described as a 'gold standard' test in functional balance evaluation.
Weight-bearing Lunge Test Weight-bearing lunge test
Dorsi flexion range of motion was measured as the range of motion of the ankle joint. In the test, the patient was initially positioned standing against the wall. The second toe and heel of the foot to be measured were adjusted so that the midpoint of the knee was perpendicular to the wall. Then, the patient was asked to move forward without lifting his heel off the ground, and to touch his knee to the wall. The furthest distance that the patient could touch the wall without raising the heel was determined. The distance between the tip of the second finger and the wall was measured in cm. Three trials were performed and the mean value was recorded for analysis. Test is a valid and reliable test for measuring dorsiflexion.

Secondary Outcome Measures

Functional Reach Test
The results do not adequately represent functional activities in daily life, since in many test protocols for evaluating the stability limits of the individual, the evaluation is performed during forward bending without using the upper extremity. Functional reach is a function that takes place in many daily activities and creates constant stress on balance. Voluntary upper extremity movements are accompanied by postural stabilizing activities of the leg and trunk muscles, and postural control mechanisms must be preserved for upper extremity movements in the standing position. It is defined as the maximum distance that an individual can reach forward in the horizontal plane while maintaining stability on the support surface in the standing position. Functional reach; It can be measured in two ways as electronic functional reach measurement and functional reach measurement with tape measure. Measuring with a tape measure is very practical.
Manual Muscle Test
Manual Muscle Test, which scored individuals' muscle strength values between 0 and 5, was used. In the muscle test, the patient is placed in the starting position of the movement and asked to do the movement. Motivation is increased by giving verbal warnings. Muscle tests should be started with a value of 3. If the patient can easily make this value, the values of 3+, 4 and 5 are checked. If it cannot reach the value of 3, the values of 2.1 and 0 should be checked.

Full Information

First Posted
September 17, 2022
Last Updated
January 31, 2023
Sponsor
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05549063
Brief Title
Effect of Different Exercise Approaches on Balance and Proprioception in Individuals With Pes Planus
Official Title
Effect of Different Exercise Approaches on Balance and Proprioception in Individuals With Pes Planus
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
September 17, 2022 (Actual)
Primary Completion Date
October 17, 2022 (Actual)
Study Completion Date
January 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital

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
Pes planus; It can be defined as the valgus of the hindfoot while loading the foot, the disappearance of the medial longitudinal arch in the midfoot, and the supination of the forefoot relative to the hindfoot. It may also occur due to the fact that the medial longitudinal arch in the foot is lower than the required height according to the anatomical position. The parts of the foot that touch the ground are anatomically healthy in a person; They are the heads of the calcaneus tuberositas calcanei on the back of the foot and the 5 metatarsal bones on the front of the foot. In the standing position, 25% of our body weight is on the tuber calcanei, while 25% is on the 5 metatarsal bones. In individuals with pes planus, convergence of the sole of the midfoot to the ground may even result in the sole of the midfoot touching the ground at its advanced levels. It is one of the common foot deformities.
Detailed Description
Pes planus can cause symptoms and dysfunction that are symptomatic or severe enough to limit patients' quality of life. Degeneration of the posterior tibial tendon may occur due to trauma, neuroarthropathy, neuromuscular disease and inflammatory arthritis. Among these, the most common cause of pes planus is the degeneration of the posterior tibial tendon. The highest arch of the foot, the medical longitudinal arch calcaneus, talus, navicular, cuneiform and 1-2-3. It is formed by metatarsals. It is effective in the distribution of the load on the feet. Plantar ligaments are important in protecting the dome of the foot. They used many definitions known as pes planus, that is, flat feet in the literature. Weak foot, relaxed foot, pes valgus, congenital hypermobile flat foot, hypermobile flat foot, flaccid flat food, talipes calcaneovalgus, compensated talipes equinus can be given as examples. Balance disorders and general joint hypermobility are among the clinical symptoms of pes planus. In a study conducted with 100 individuals aged between 18 and 45, when the balance time of individuals without pes planus was compared with the balance time of individuals with pes planus; It was determined that individuals without pes planus had better balance times. It has been determined that as the degree of pes planus increases, the time to stay in balance decreases in individuals. Stretching exercises; It is defined as the pulling force applied to lengthen the muscle and connective tissues in the human body. Stretching exercises are divided into 4 in themselves. These; dynamic stretching, static stretching, ballistic stretching and PNF stretching. Mobility exercises; It consists of low-speed, variable-intensity, repetitive, passive movements applied to joints and ligaments within the normal range of joint motion. Stability exercises; It is defined as the ability to control joint movement or position by coordinating the movements of the surrounding tissues and neuromuscular system.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pes Planus
Keywords
Exercise, Stability exercises, Mobility exercises, Stretching exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
It is planned to randomly divide 40 individuals diagnosed with pes planus by the physician into two. In these groups, there should be a pes planus problem on both sides. The first group will be given stretching exercises, while the second group will be given mobility and stability exercises.
Masking
ParticipantInvestigator
Masking Description
Evaluation and treatment will be carried out by different physiotherapists. In this way, it is aimed to provide an objective evaluation.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobility and Stability Exercise
Arm Type
Experimental
Arm Description
The patients were divided into two groups. Exercises were applied to both groups for 4 weeks.
Arm Title
Stretching Exercise
Arm Type
Active Comparator
Arm Description
The patients were divided into two groups. Exercises were applied to both groups for 4 weeks.
Intervention Type
Other
Intervention Name(s)
Mobility and Stability Exercise
Intervention Description
Mobility and stability exercises were given to the first group, while stretching exercises were given to the other group. The number of repetitions and content of the exercises were determined before the treatment, and the same repetitions were given to both groups.
Intervention Type
Other
Intervention Name(s)
Stretching Exercise
Intervention Description
Balance and reaching exercise, heel rise, towel picking exercise, 4-way resistance exercise, half kneeling knee to wall, single leg ankle, single leg balance with leg stretched, ice bottle rolling under the feet were performed in the first group. Achilles stretching, wall side gastrosoleus stretching, sitting plantar fascia stretching, towel gastrosoleus stretching, sitting dorsiflexion stretching with teraban were performed in the second group.
Primary Outcome Measure Information:
Title
Star Excursion Balance Test
Description
It is used to measure dynamic postural balance. The test is based on the ability to reach the farthest possible distance on the supporting leg in 8 different directions. The person reaches as far as he can reach with his foot and touches the strip lightly with the tip of his toe. Then it returns to the starting position. Then the other line is passed and a total of 8 lines are completed in this way. After the whole process is repeated 3 times with the right foot, the left foot is changed and it is repeated 3 times. The participant records the distances reached at the end of the test. We have 16 scores left for 8 right and 8 left feet in total. Reach (%) = Reach distance / Leg length x 100
Time Frame
4 weeks
Title
Range of Motion Measurement
Description
Dorsiflexion, plantar flexion, inversion and eversion ranges of motion of the ankle joints of individuals are actively measured using a universal goniometer and recorded in degrees.
Time Frame
4 weeks
Title
Berg Balance Test
Description
Berg Balance Test It consists of 14 general balance activities that change the orientation of the body's center of gravity with respect to the support surface and evaluate the ability to maintain a static position while decreasing on the support surface. During the activities, the patient is evaluated by the observer, and the score for each activity is determined, ranging from 0 to 4. The highest score corresponds to the ability to complete the activity quickly and easily. The highest overall score is 56 and reflects a perfect balance function. The closer the score is from 56 to 36, the greater the risk of falling. It is described as a 'gold standard' test in functional balance evaluation.
Time Frame
4 weeks
Title
Weight-bearing Lunge Test Weight-bearing lunge test
Description
Dorsi flexion range of motion was measured as the range of motion of the ankle joint. In the test, the patient was initially positioned standing against the wall. The second toe and heel of the foot to be measured were adjusted so that the midpoint of the knee was perpendicular to the wall. Then, the patient was asked to move forward without lifting his heel off the ground, and to touch his knee to the wall. The furthest distance that the patient could touch the wall without raising the heel was determined. The distance between the tip of the second finger and the wall was measured in cm. Three trials were performed and the mean value was recorded for analysis. Test is a valid and reliable test for measuring dorsiflexion.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Functional Reach Test
Description
The results do not adequately represent functional activities in daily life, since in many test protocols for evaluating the stability limits of the individual, the evaluation is performed during forward bending without using the upper extremity. Functional reach is a function that takes place in many daily activities and creates constant stress on balance. Voluntary upper extremity movements are accompanied by postural stabilizing activities of the leg and trunk muscles, and postural control mechanisms must be preserved for upper extremity movements in the standing position. It is defined as the maximum distance that an individual can reach forward in the horizontal plane while maintaining stability on the support surface in the standing position. Functional reach; It can be measured in two ways as electronic functional reach measurement and functional reach measurement with tape measure. Measuring with a tape measure is very practical.
Time Frame
4 weeks
Title
Manual Muscle Test
Description
Manual Muscle Test, which scored individuals' muscle strength values between 0 and 5, was used. In the muscle test, the patient is placed in the starting position of the movement and asked to do the movement. Motivation is increased by giving verbal warnings. Muscle tests should be started with a value of 3. If the patient can easily make this value, the values of 3+, 4 and 5 are checked. If it cannot reach the value of 3, the values of 2.1 and 0 should be checked.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Having mild and moderate pes planus, Volunteering of individuals, Being between the age group of 18-40, Having experienced at least one inflammatory symptom (pain, swelling, etc.) Not having any systemic, locomotor and foot related diseases, sensory loss, diabetic and peripheral neuropathy. Exclusion Criteria: Having had a serious lower extremity injury in the last 6 months, Getting a full score from the balance test, Having ligament rupture in the ankle.
Facility Information:
Facility Name
Medipol hospital
City
Istanbul
ZIP/Postal Code
34070
Country
Turkey

12. IPD Sharing Statement

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Effect of Different Exercise Approaches on Balance and Proprioception in Individuals With Pes Planus

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