NCT04734899

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 2, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

February 2, 2021

Status Verified

January 1, 2021

Enrollment Period

6 months

First QC Date

January 22, 2021

Last Update Submit

January 28, 2021

Conditions

Keywords

Pes planusElectromyographyGaitBalance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (14)

  • Y balance test (YBT):

    Just before the training and at the end of 8-week training

  • Vertical jump, flight time

    Just before the training and at the end of 8-week training

  • Vertical jump, jump height

    Just before the training and at the end of 8-week training

  • Vertical jump, power

    Just before the training and at the end of 8-week training

  • vertical jump, position difference

    Just before the training and at the end of 8-week training

  • +9 more secondary outcomes

Study Arms (2)

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.

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.

Other: Exercise programOther: Foot core training

Interventions

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

Control grupFoot core grup

Short foot exercises with passive modeling, active assisted modeling, active modeling, functional training

Foot core grup

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yıldırım Beyazıt University

Ankara, 06370, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 22142711BACKGROUND
  • 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.

    PMID: 24659509BACKGROUND
  • 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.

    PMID: 23632367BACKGROUND
  • 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.

    PMID: 27942135BACKGROUND
  • 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.

    PMID: 20647944BACKGROUND

MeSH Terms

Conditions

Flatfoot

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ertuğrul Demirdel, PhD

    Ankara Yildirim Beyazıt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 22, 2021

First Posted

February 2, 2021

Study Start

January 1, 2021

Primary Completion

July 1, 2021

Study Completion

August 1, 2021

Last Updated

February 2, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations