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Foot Core Training in Individuals With Pes Planus

Primary Purpose

Pes Planus

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise program
Foot core training
Sponsored by
Ankara Yildirim Beyazıt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pes Planus focused on measuring Pes planus, Electromyography, Gait, Balance

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Individuals who volunteer to participate in the study
  • Individuals between the ages of 18-25
  • Individuals with a body mass index between 18.5-30.
  • Individuals with a difference of 10 mm or more between weighted and unweighted measurements by applying the navicular drop test
  • Individuals who are considered to have flexible pes planus with a positive Jack's finger lift test

Exclusion Criteria:

  • Individuals with symptoms such as any pain in the foot and ankle, fatigue.
  • Individuals with any neurological or orthopedic disease affecting the lower extremity.
  • Individuals with a history of foot-ankle trauma-surgery
  • Individuals with lower extremity inequality of more than 1 centimeter (cm)

Sites / Locations

  • Ankara Yıldırım Beyazıt University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control grup

Foot core grup

Arm Description

All individuals participating in the study will be taught the exercises given to strengthen weakened muscles, stretch shortened structures and increase proprioception by the physiotherapist and will be asked to do these exercises at least twice a day for 8 weeks. The home program will be followed by the exercise daily form.

In addition to the exercise program given to the control group, foot core training will be added and taught by the physiotherapist and they will be asked to do these exercises at least twice a day for 8 weeks.

Outcomes

Primary Outcome Measures

Evaluation of muscle activation
In our study, muscle activations of the tibialis anterior, peroneus longus and abductor hallucis muscles both during maximum isometric contraction and during walking will be evaluated by a trained and experienced researcher using the sEMG device.

Secondary Outcome Measures

Y balance test (YBT):
There are 3 bars of 1.5 meters long fixed to a 2.54 cm high central foot plate at an angle of 135 and 90 degrees between them. It is asked to lie down with the tip of the toe in 3 directions and the measurements are recorded.
Vertical jump, flight time
Vertical jumping and jumping on one foot will be evaluated with MicroGate Opto-jump Next®. With this test, flight time will be measured during vertical jump, and it will be recorded by seconds.
Vertical jump, jump height
Vertical jumping and jumping on one foot will be evaluated with MicroGate Opto-jump Next®. Jump height wil be recorded by centimeters.
Vertical jump, power
Vertical jumping and jumping on one foot will be evaluated with MicroGate Opto-jump Next®. Power will be recorded by watt/kilogram.
vertical jump, position difference
Vertical jumping and jumping on one foot will be evaluated with MicroGate Opto-jump Next®. Position difference will be measured by centimeters.
Cadence
It will be evaluated using a digital miniature gait analysis system. Participants will be asked to walk on the 20-meter track and as a result of the analysis cadence will be recorded as steps per minute.
Gait speed
It will be evaluated using a digital miniature gait analysis system. Participants will be asked to walk on the 20-meter track and as a result of the analysis, gait speed will be measured as meter/seconds.
Step width
It will be evaluated using a digital miniature gait analysis system. Participants will be asked to walk on the 20-meter track and step width will be measured as centimeter.
Ratio of step length to step height
It will be evaluated using a digital miniature gait analysis system. Participants will be asked to walk on the 20-meter track and as a result of the analysis, ratio of step length to step height will be calculated as a percentage.
Standing phase duration
It will be evaluated using a digital miniature gait analysis system. Participants will be asked to walk on the 20-meter track. Standing phase duration will be recorded as seconds.
Swing phase duration
It will be evaluated using a digital miniature gait analysis system. Participants will be asked to walk on the 20-meter track. Swing phase duration will be recorded as seconds.
Double support period duration
It will be evaluated using a digital miniature gait analysis system. Participants will be asked to walk on the 20-meter track and as a result of the analysis, double support period duration will be recorded as seconds.
Single support period time
It will be evaluated using a digital miniature gait analysis system. Participants will be asked to walk on the 20-meter track and as a result of the analysis, single support period time will be recorded as seconds.
Acceleration
It will be evaluated using a digital miniature gait analysis system. Participants will be asked to walk on the 20-meter track and as a result of the analysis, at what moments and at what speed the acceleration during walking will be reached as seconds and meter/second, respectively.

Full Information

First Posted
January 22, 2021
Last Updated
January 28, 2021
Sponsor
Ankara Yildirim Beyazıt University
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1. Study Identification

Unique Protocol Identification Number
NCT04734899
Brief Title
Foot Core Training in Individuals With Pes Planus
Official Title
The Effects of Foot-Core Training on Muscle Activations, Walking, Balance and Lower Extremity Performance in Individuals With Pes Planus
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
August 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Yildirim Beyazıt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Foot core training is very important for the intrinsic muscles of the foot, but it is often neglected in exercise programs given to individuals with pes planus. The aim of our study is to reveal the effects of foot core training, which will be added to the exercise program routinely given to individuals with asymptomatic flexible pes planus, on walking, muscular activations, balance and lower extremity functional performance with objective, evidence based results.
Detailed Description
This study is a randomized controlled study and will be carried out on volunteer individuals with asymptomatic flexible pes planus aged between 18-25, studying at Alanya Alaaddin Keykubat University. Persons meeting the inclusion criteria will be determined by the specialist physiotherapist. Surface electromyography (sEMG) measurements will be made by a doctorate physiotherapist. Other evaluations will be made by a specialist physiotherapist. Individuals who meet the inclusion criteria, who volunteered to participate in the study and signed the consent sheet will be randomly divided into two groups, the control group and the foot core group. Individuals with initial evaluations will be followed up in an exercise program planned for 8 weeks. The control group will be given exercises to strengthen the weakened muscles, stretch the shortened structures and increase proprioception. Foot core training will be given to the study group in addition to the exercises given to the control group. Before and after exercise, the subjects will be assessed with navicular height measurement, muscle activation evaluation, evaluation of walking parameters, functional lower extremity performance evaluation and balance evaluation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pes Planus
Keywords
Pes planus, Electromyography, Gait, Balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized controlled trial: Two parallel treatment groups; The control group will only receive exercise therapy, while the other group will receive foot core training in addition to exercise therapy
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control grup
Arm Type
Active Comparator
Arm Description
All individuals participating in the study will be taught the exercises given to strengthen weakened muscles, stretch shortened structures and increase proprioception by the physiotherapist and will be asked to do these exercises at least twice a day for 8 weeks. The home program will be followed by the exercise daily form.
Arm Title
Foot core grup
Arm Type
Experimental
Arm Description
In addition to the exercise program given to the control group, foot core training will be added and taught by the physiotherapist and they will be asked to do these exercises at least twice a day for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Exercise program
Intervention Description
Strengthening with resistance bands for tibialis posterior, tibialis anterior, peroneus longus, finger flexors, hip and knee muscles, sheet gathering exercises, fingertip walking exercises, Stretching exercises for gastrocnemius and soleus muscles, plantar fascia stretching, weight transfer on one leg
Intervention Type
Other
Intervention Name(s)
Foot core training
Intervention Description
Short foot exercises with passive modeling, active assisted modeling, active modeling, functional training
Primary Outcome Measure Information:
Title
Evaluation of muscle activation
Description
In our study, muscle activations of the tibialis anterior, peroneus longus and abductor hallucis muscles both during maximum isometric contraction and during walking will be evaluated by a trained and experienced researcher using the sEMG device.
Time Frame
Change from baseline muscle activation at 8 weeks
Secondary Outcome Measure Information:
Title
Y balance test (YBT):
Description
There are 3 bars of 1.5 meters long fixed to a 2.54 cm high central foot plate at an angle of 135 and 90 degrees between them. It is asked to lie down with the tip of the toe in 3 directions and the measurements are recorded.
Time Frame
Just before the training and at the end of 8-week training
Title
Vertical jump, flight time
Description
Vertical jumping and jumping on one foot will be evaluated with MicroGate Opto-jump Next®. With this test, flight time will be measured during vertical jump, and it will be recorded by seconds.
Time Frame
Just before the training and at the end of 8-week training
Title
Vertical jump, jump height
Description
Vertical jumping and jumping on one foot will be evaluated with MicroGate Opto-jump Next®. Jump height wil be recorded by centimeters.
Time Frame
Just before the training and at the end of 8-week training
Title
Vertical jump, power
Description
Vertical jumping and jumping on one foot will be evaluated with MicroGate Opto-jump Next®. Power will be recorded by watt/kilogram.
Time Frame
Just before the training and at the end of 8-week training
Title
vertical jump, position difference
Description
Vertical jumping and jumping on one foot will be evaluated with MicroGate Opto-jump Next®. Position difference will be measured by centimeters.
Time Frame
Just before the training and at the end of 8-week training
Title
Cadence
Description
It will be evaluated using a digital miniature gait analysis system. Participants will be asked to walk on the 20-meter track and as a result of the analysis cadence will be recorded as steps per minute.
Time Frame
Just before the training and at the end of 8-week training
Title
Gait speed
Description
It will be evaluated using a digital miniature gait analysis system. Participants will be asked to walk on the 20-meter track and as a result of the analysis, gait speed will be measured as meter/seconds.
Time Frame
Just before the training and at the end of 8-week training
Title
Step width
Description
It will be evaluated using a digital miniature gait analysis system. Participants will be asked to walk on the 20-meter track and step width will be measured as centimeter.
Time Frame
Just before the training and at the end of 8-week training
Title
Ratio of step length to step height
Description
It will be evaluated using a digital miniature gait analysis system. Participants will be asked to walk on the 20-meter track and as a result of the analysis, ratio of step length to step height will be calculated as a percentage.
Time Frame
Just before the training and at the end of 8-week training
Title
Standing phase duration
Description
It will be evaluated using a digital miniature gait analysis system. Participants will be asked to walk on the 20-meter track. Standing phase duration will be recorded as seconds.
Time Frame
Just before the training and at the end of 8-week training
Title
Swing phase duration
Description
It will be evaluated using a digital miniature gait analysis system. Participants will be asked to walk on the 20-meter track. Swing phase duration will be recorded as seconds.
Time Frame
Just before the training and at the end of 8-week training
Title
Double support period duration
Description
It will be evaluated using a digital miniature gait analysis system. Participants will be asked to walk on the 20-meter track and as a result of the analysis, double support period duration will be recorded as seconds.
Time Frame
Just before the training and at the end of 8-week training
Title
Single support period time
Description
It will be evaluated using a digital miniature gait analysis system. Participants will be asked to walk on the 20-meter track and as a result of the analysis, single support period time will be recorded as seconds.
Time Frame
Just before the training and at the end of 8-week training
Title
Acceleration
Description
It will be evaluated using a digital miniature gait analysis system. Participants will be asked to walk on the 20-meter track and as a result of the analysis, at what moments and at what speed the acceleration during walking will be reached as seconds and meter/second, respectively.
Time Frame
Just before the training and at the end of 8-week training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals who volunteer to participate in the study Individuals between the ages of 18-25 Individuals with a body mass index between 18.5-30. Individuals with a difference of 10 mm or more between weighted and unweighted measurements by applying the navicular drop test Individuals who are considered to have flexible pes planus with a positive Jack's finger lift test Exclusion Criteria: Individuals with symptoms such as any pain in the foot and ankle, fatigue. Individuals with any neurological or orthopedic disease affecting the lower extremity. Individuals with a history of foot-ankle trauma-surgery Individuals with lower extremity inequality of more than 1 centimeter (cm)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ertuğrul Demirdel, PhD
Organizational Affiliation
Ankara Yildirim Beyazıt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara Yıldırım Beyazıt University
City
Ankara
ZIP/Postal Code
06370
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22142711
Citation
Jung DY, Koh EK, Kwon OY. Effect of foot orthoses and short-foot exercise on the cross-sectional area of the abductor hallucis muscle in subjects with pes planus: a randomized controlled trial. J Back Musculoskelet Rehabil. 2011;24(4):225-31. doi: 10.3233/BMR-2011-0299.
Results Reference
background
PubMed Identifier
24659509
Citation
McKeon PO, Hertel J, Bramble D, Davis I. The foot core system: a new paradigm for understanding intrinsic foot muscle function. Br J Sports Med. 2015 Mar;49(5):290. doi: 10.1136/bjsports-2013-092690. Epub 2014 Mar 21.
Results Reference
background
PubMed Identifier
23632367
Citation
Mulligan EP, Cook PG. Effect of plantar intrinsic muscle training on medial longitudinal arch morphology and dynamic function. Man Ther. 2013 Oct;18(5):425-30. doi: 10.1016/j.math.2013.02.007. Epub 2013 Apr 28.
Results Reference
background
PubMed Identifier
27942135
Citation
Kim EK, Kim JS. The effects of short foot exercises and arch support insoles on improvement in the medial longitudinal arch and dynamic balance of flexible flatfoot patients. J Phys Ther Sci. 2016 Nov;28(11):3136-3139. doi: 10.1589/jpts.28.3136. Epub 2016 Nov 29.
Results Reference
background
PubMed Identifier
20647944
Citation
Glatthorn JF, Gouge S, Nussbaumer S, Stauffacher S, Impellizzeri FM, Maffiuletti NA. Validity and reliability of Optojump photoelectric cells for estimating vertical jump height. J Strength Cond Res. 2011 Feb;25(2):556-60. doi: 10.1519/JSC.0b013e3181ccb18d.
Results Reference
background

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Foot Core Training in Individuals With Pes Planus

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