- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04734899
Foot Core Training in Individuals With Pes Planus
January 28, 2021 updated by: Ertuğrul Demirdel, Ankara Yildirim Beyazıt University
The Effects of Foot-Core Training on Muscle Activations, Walking, Balance and Lower Extremity Performance in Individuals With Pes Planus
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
26
Phase
- 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
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Ankara, Turkey, 06370
- Ankara Yıldırım Beyazıt University
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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
Ages Eligible for Study
18 years to 25 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control grup
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. |
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
|
Experimental: Foot core grup
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.
|
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
Short foot exercises with passive modeling, active assisted modeling, active modeling, functional training
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of muscle activation
Time Frame: Change from baseline muscle activation at 8 weeks
|
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.
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Change from baseline muscle activation at 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Y balance test (YBT):
Time Frame: Just before the training and at the end of 8-week training
|
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.
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Just before the training and at the end of 8-week training
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Vertical jump, flight time
Time Frame: Just before the training and at the end of 8-week training
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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.
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Just before the training and at the end of 8-week training
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Vertical jump, jump height
Time Frame: Just before the training and at the end of 8-week training
|
Vertical jumping and jumping on one foot will be evaluated with MicroGate Opto-jump Next®.
Jump height wil be recorded by centimeters.
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Just before the training and at the end of 8-week training
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Vertical jump, power
Time Frame: Just before the training and at the end of 8-week training
|
Vertical jumping and jumping on one foot will be evaluated with MicroGate Opto-jump Next®.
Power will be recorded by watt/kilogram.
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Just before the training and at the end of 8-week training
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vertical jump, position difference
Time Frame: Just before the training and at the end of 8-week training
|
Vertical jumping and jumping on one foot will be evaluated with MicroGate Opto-jump Next®.
Position difference will be measured by centimeters.
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Just before the training and at the end of 8-week training
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Cadence
Time Frame: Just before the training and at the end of 8-week training
|
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.
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Just before the training and at the end of 8-week training
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Gait speed
Time Frame: Just before the training and at the end of 8-week training
|
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.
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Just before the training and at the end of 8-week training
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Step width
Time Frame: Just before the training and at the end of 8-week training
|
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.
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Just before the training and at the end of 8-week training
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Ratio of step length to step height
Time Frame: Just before the training and at the end of 8-week training
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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.
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Just before the training and at the end of 8-week training
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Standing phase duration
Time Frame: Just before the training and at the end of 8-week training
|
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.
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Just before the training and at the end of 8-week training
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Swing phase duration
Time Frame: Just before the training and at the end of 8-week training
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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.
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Just before the training and at the end of 8-week training
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Double support period duration
Time Frame: Just before the training and at the end of 8-week training
|
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.
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Just before the training and at the end of 8-week training
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Single support period time
Time Frame: Just before the training and at the end of 8-week training
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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.
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Just before the training and at the end of 8-week training
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Acceleration
Time Frame: Just before the training and at the end of 8-week training
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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.
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Just before the training and at the end of 8-week training
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
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)
January 1, 2021
Primary Completion (Anticipated)
July 1, 2021
Study Completion (Anticipated)
August 1, 2021
Study Registration Dates
First Submitted
January 22, 2021
First Submitted That Met QC Criteria
January 28, 2021
First Posted (Actual)
February 2, 2021
Study Record Updates
Last Update Posted (Actual)
February 2, 2021
Last Update Submitted That Met QC Criteria
January 28, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020/15-04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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