Pes PlanusNCT04734899
Foot Core Training in Individuals With Pes Planus
A study testing Exercise program and Foot core training in people with Pes Planus, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Pes Planus
- What is being tested?
- Exercise program and Foot core training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yıldırım Beyazıt University
Ankara, 06370
About this study
Official title: 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.
Read the 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.
- Conditions
- Pes Planus
- Being tested
- Exercise program, Foot core training
- Keywords
- Pes planus, Electromyography, Gait, Balance
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise programOther
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 trainingOther
Short foot exercises with passive modeling, active assisted modeling, active modeling, functional training
| Study group | Role | What they receive |
|---|---|---|
| Control grup | Active comparator | 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. Receives: Other: Exercise program |
| Foot core grup | Experimental | 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. Receives: Other: Exercise program; Other: Foot core training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline muscle activation at 8 weeks
Secondary outcomes (14)
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.
Measured: Just before the training and at the end of 8-week training
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.
Measured: Just before the training and at the end of 8-week training
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.
Measured: Just before the training and at the end of 8-week training
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.
Measured: Just before the training and at the end of 8-week training
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.
Measured: Just before the training and at the end of 8-week training
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.
Measured: Just before the training and at the end of 8-week training
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.
Measured: Just before the training and at the end of 8-week training
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.
Measured: Just before the training and at the end of 8-week training
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.
Measured: Just before the training and at the end of 8-week training
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.
Measured: Just before the training and at the end of 8-week training
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.
Measured: Just before the training and at the end of 8-week training
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.
Measured: Just before the training and at the end of 8-week training
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.
Measured: Just before the training and at the end of 8-week training
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.
Measured: Just before the training and at the end of 8-week training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start1 Jan 2021
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pes PlanusStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ertuğrul Demirdel, Ankara Yildirim Beyazıt University
- Investigators
- Ertuğrul Demirdel, PhD, Principal investigator, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734899
- Sponsor's protocol ID
- 2020/15-04
- Status last verified
- Jan 2021
- First submitted
- 22 Jan 2021
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 22142711McKeon 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.
PubMed 24659509Mulligan 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.
PubMed 23632367Kim 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.
PubMed 27942135Glatthorn 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.
PubMed 20647944
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Foot-Core Training on Muscle Activations, Walking, Balance and Lower Extremity Performance in Individuals With Pes Planus
- ClinicalTrials.gov ID
- NCT04734899
- Acronym / sponsor ID
- 2020/15-04
- Conditions
- Pes Planus
- Keywords
- Pes planus, Electromyography, Gait, Balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 2 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Control grup | Active comparator | Other: Exercise programAll 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. |
| Foot core grup | Experimental | Other: Exercise program, Other: Foot core trainingIn 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise programStrengthening 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 | Other | Control grup, Foot core grup |
| Foot core trainingShort foot exercises with passive modeling, active assisted modeling, active modeling, functional training | Other | Foot core grup |
Primary outcome
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.
14 secondary outcomes
Y balance test (YBT):
Time frame: Just before the training and at the end of 8-week training
Vertical jump, flight time
Time frame: Just before the training and at the end of 8-week training
Vertical jump, jump height
Time frame: Just before the training and at the end of 8-week training
Vertical jump, power
Time frame: Just before the training and at the end of 8-week training
vertical jump, position difference
Time frame: Just before the training and at the end of 8-week training
Cadence
Time frame: Just before the training and at the end of 8-week training
Gait speed
Time frame: Just before the training and at the end of 8-week training
Step width
Time frame: Just before the training and at the end of 8-week training
Ratio of step length to step height
Time frame: Just before the training and at the end of 8-week training
Standing phase duration
Time frame: Just before the training and at the end of 8-week training
Swing phase duration
Time frame: Just before the training and at the end of 8-week training
Double support period duration
Time frame: Just before the training and at the end of 8-week training
Single support period time
Time frame: Just before the training and at the end of 8-week training
Acceleration
Time frame: Just before the training and at the end of 8-week training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Background: PubMed 22142711Jung 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.
- Background: PubMed 24659509McKeon 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.
- Background: PubMed 23632367Mulligan 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.
- Background: PubMed 27942135Kim 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.
- Background: PubMed 20647944Glatthorn 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ertuğrul Demirdel, PhD principal investigator
Ankara Yildirim Beyazıt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise program and Foot core training in people with Pes Planus, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of muscle activation (time frame: Change from baseline muscle activation at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04734899, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.