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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04734899
Other study ID # 2020/15-04
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 1, 2021
Est. completion date August 1, 2021

Study information

Verified date January 2021
Source Ankara Yildirim Beyazit University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 26
Est. completion date August 1, 2021
Est. primary completion date July 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 25 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise program
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
Foot core training
Short foot exercises with passive modeling, active assisted modeling, active modeling, functional training

Locations

Country Name City State
Turkey Ankara Yildirim Beyazit University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Ankara Yildirim Beyazit University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View 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. — View 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. Epub 2016 Nov 29. — View 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. Review. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Change from baseline muscle activation at 8 weeks
Secondary 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. Just before the training and at the end of 8-week training
Secondary 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. Just before the training and at the end of 8-week training
Secondary 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. Just before the training and at the end of 8-week training
Secondary 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. Just before the training and at the end of 8-week training
Secondary 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. Just before the training and at the end of 8-week training
Secondary 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. Just before the training and at the end of 8-week training
Secondary 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. Just before the training and at the end of 8-week training
Secondary 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. Just before the training and at the end of 8-week training
Secondary 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. Just before the training and at the end of 8-week training
Secondary 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. Just before the training and at the end of 8-week training
Secondary 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. Just before the training and at the end of 8-week training
Secondary 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. Just before the training and at the end of 8-week training
Secondary 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. Just before the training and at the end of 8-week training
Secondary 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. Just before the training and at the end of 8-week training
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