NCT05774327

Brief Summary

Pes planus is a foot deformity characterized by a low medial longitudinal arch. It is more common in young adults. With low arch, tension occurs in the plantar fascia. Fascia and soft tissue loading may lead to different musculoskeletal problems such as plantar fasciitis, medial tibial stress syndrome, patellofemoral disorders and back pain. In addition, pes planus can affect individuals' activities of daily living, productivity in occupational settings, and injury risk and performance in sports. Treatment of pes planus includes strengthening, stretching, taping and orthotics for the foot muscles. Among these applications, strengthening of the foot core muscles is one of the most common and effective methods. By strengthening the foot core muscles, it is aimed to reduce the effect of the kinetic chain. Pes planus is a postural deformity that affects the kinetic and fascial chain, but the treatment program is usually planned regionally. With fascial continuity and fascial conduction, the tension on the plantar fascia in pes planus affects the gastro-soleus, peroneus longus and brevis, hamstring muscles, iliotibial band and thoracolumbar fascia. Stretching of the plantar fascia, which is included in current treatment programs, has only a local effect and thus cannot prevent fascial chain involvement. Myofascial release, one of the methods used to reduce the tension in the fascia, has been used frequently in recent years. Myofascial release is performed with methods such as manual, foam roller and instrument assisted release. Foam roller (cylinder foam) is a practical myofascial release method that can be self-applied by the individual. In addition to strengthening the intrinsic muscles of the foot in individuals with pes planus, it has been reported that fascial chain involvement should also be taken into consideration due to the tension in the plantar fascia with low arch. This study was planned to investigate the effect of myofascial release methods on lower extremity performance in addition to foot core exercises used effectively in the treatment of pes planus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 4, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 17, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

March 20, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2023

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

2 months

First QC Date

March 4, 2023

Last Update Submit

October 9, 2023

Conditions

Keywords

Pes PlanusFoot Core ExercisesMyofascial ReleaseFoam Rolling

Outcome Measures

Primary Outcomes (1)

  • Change in Balance

    The Y balance test is used for balance assessment. A "Y" shaped design is made using three tape measures placed on the ground. After the first tape measure is placed in the anterior (ant) direction, the other two tape measures are placed on the ground in the posteromedial (pm) and posterolateral (pl) directions to form a 135-degree angle. How the test will be performed is clearly explained to the individuals before the test and they are allowed to perform three trials. With the hands on the waist, the fingertip reach in each of the three directions is recorded in centimeters (cm). The maximum distance they can reach in three reaches in each direction is recorded. This process is also repeated while standing on the other limb and recorded. Lower limb length is calculated by measuring the distance between the spina iliaca anterior superior and the medial malleolus with a tape measure. With the results obtained, the normalized reach and the composite reach for both limbs are calculated.

    Change from Baseline Y Balance Test Results at 6 weeks.

Secondary Outcomes (3)

  • Change in Flexibility

    Change from Baseline Sit and Reach Test Results at 6 weeks.

  • Change in Power

    Change from Baseline Vertical Jump Test Results at 6 weeks.

  • Change in Gait

    Change from Baseline 10-Meter Walk Test Results at 6 weeks.

Study Arms (2)

Foam Roller+Foot Core Exercises Group

EXPERIMENTAL

Participants in the foam roller+exercise group underwent foam roller application, which is a self-myofascial release method, 2 days a week for 6 weeks in addition to exercises. Medium-hard foam rollers were used in the applications. Foam roller application was performed on thoracolumbar fascia, iliotibial band, hamstring, gastro-soleus, peroneals and plantar fascia for 60 seconds on each region. A metronome was used to determine the rhythm during foam roller application. The rhythm of the metronome was set to 60 beats per minute (60 rpm). When determining the amount of load on the tissue, the participants were told to give the maximum amount of load possible.

Other: Foam RollerOther: Foot Core Exercises

Foot Core Exercises Group

EXPERIMENTAL

The foot core exercises in the treatment program for young adults with pes planus were taught to the participants one by one. It was checked that each exercise in the program was performed correctly by the participants. An exercise brochure was prepared and given to all participants so that the participants could learn the exercises better and perform them correctly. The exercise program follow-up of the participants and gradual progression of the difficulty levels were performed by the responsible researcher. The exercises were performed two days a week for six weeks under the supervision of the researcher. On the other days, the exercise program follow-up was checked daily via an online platform.

Other: Foot Core Exercises

Interventions

Participants will be shown 7 different foot core exercises and will be instructed to do 10 repetitions 3 times a day. For 6 weeks, in addition to foot core exercises, myofascial release will be applied with foam roller 2 days a week. Myofascial release application areas; thoracolumbal fascia, iliotibial band, hamstring, gastro-soleus, peroneal, plantar fascia.

Also known as: Foot Core Exercises
Foam Roller+Foot Core Exercises Group

Participants will be shown 7 different foot core exercises and will be instructed to do 10 repetitions 3 times a day. Foot core exercises; short foot exercise, toe flexion exercise, heel lift exercise,toe abduction exercise, big toe and other toes extension exercise, front swing exercise, back walking exercises. Participants will do the exercises with the researcher two days a week and the other days follow-up will be provided through the online platform.

Foam Roller+Foot Core Exercises GroupFoot Core Exercises Group

Eligibility Criteria

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

You may qualify if:

  • Be between the ages of 18-25,
  • Bilateral navicular drop distance of 10 mm or more,
  • Bilateral asymptomatic flexible pes planus,
  • Volunteering to participate in the study and being able to continue.

You may not qualify if:

  • Musculoskeletal disorders other than pes planus,
  • Having chronic ankle instability,
  • Any lower extremity injury in the last 6 months,
  • Receiving a treatment related to pes planus in the last 6 months,
  • Use of insoles.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yıldırım Beyazıt University, Institute of Health Sciences, Department of Physiotherapy and Rehabilitation

Ankara, Turkey (Türkiye)

Location

Related Publications (15)

  • Sulowska I, Oleksy L, Mika A, Bylina D, Soltan J. The Influence of Plantar Short Foot Muscle Exercises on Foot Posture and Fundamental Movement Patterns in Long-Distance Runners, a Non-Randomized, Non-Blinded Clinical Trial. PLoS One. 2016 Jun 23;11(6):e0157917. doi: 10.1371/journal.pone.0157917. eCollection 2016.

    PMID: 27336689BACKGROUND
  • Matias AB, Taddei UT, Duarte M, Sacco IC. Protocol for evaluating the effects of a therapeutic foot exercise program on injury incidence, foot functionality and biomechanics in long-distance runners: a randomized controlled trial. BMC Musculoskelet Disord. 2016 Apr 14;17:160. doi: 10.1186/s12891-016-1016-9.

    PMID: 27075480BACKGROUND
  • Unver B, Erdem EU, Akbas E. Effects of Short-Foot Exercises on Foot Posture, Pain, Disability, and Plantar Pressure in Pes Planus. J Sport Rehabil. 2019 Oct 18;29(4):436-440. doi: 10.1123/jsr.2018-0363. Print 2020 May 1.

    PMID: 30860412BACKGROUND
  • Moon D, Jung J. Effect of Incorporating Short-Foot Exercises in the Balance Rehabilitation of Flat Foot: A Randomized Controlled Trial. Healthcare (Basel). 2021 Oct 13;9(10):1358. doi: 10.3390/healthcare9101358.

    PMID: 34683038BACKGROUND
  • Peacock CA, Krein DD, Silver TA, Sanders GJ, VON Carlowitz KA. An Acute Bout of Self-Myofascial Release in the Form of Foam Rolling Improves Performance Testing. Int J Exerc Sci. 2014 Jul 1;7(3):202-211. doi: 10.70252/DTPM9041. eCollection 2014.

    PMID: 27182404BACKGROUND
  • Behm DG, Alizadeh S, Hadjizadeh Anvar S, Mahmoud MMI, Ramsay E, Hanlon C, Cheatham S. Foam Rolling Prescription: A Clinical Commentary. J Strength Cond Res. 2020 Nov;34(11):3301-3308. doi: 10.1519/JSC.0000000000003765.

    PMID: 33105383BACKGROUND
  • D'Amico A, Silva K, Gallo J. Time Course of Acute Hip Adduction Range of Motion Changes Following Foam Rolling. Int J Sports Phys Ther. 2021 Apr 1;16(2):431-437. doi: 10.26603/001c.21417.

    PMID: 33842038BACKGROUND
  • Park DJ, Lee KS, Park SY. Effects of Two Foot-Ankle Interventions on Foot Structure, Function, and Balance Ability in Obese People with Pes Planus. Healthcare (Basel). 2021 Jun 3;9(6):667. doi: 10.3390/healthcare9060667.

    PMID: 34205155BACKGROUND
  • Rose GK, Welton EA, Marshall T. The diagnosis of flat foot in the child. J Bone Joint Surg Br. 1985 Jan;67(1):71-8. doi: 10.1302/0301-620X.67B1.3968149.

    PMID: 3968149BACKGROUND
  • Shaffer SW, Teyhen DS, Lorenson CL, Warren RL, Koreerat CM, Straseske CA, Childs JD. Y-balance test: a reliability study involving multiple raters. Mil Med. 2013 Nov;178(11):1264-70. doi: 10.7205/MILMED-D-13-00222.

    PMID: 24183777BACKGROUND
  • Plisky PJ, Rauh MJ, Kaminski TW, Underwood FB. Star Excursion Balance Test as a predictor of lower extremity injury in high school basketball players. J Orthop Sports Phys Ther. 2006 Dec;36(12):911-9. doi: 10.2519/jospt.2006.2244.

    PMID: 17193868BACKGROUND
  • Lai WC, Wang D, Chen JB, Vail J, Rugg CM, Hame SL. Lower Quarter Y-Balance Test Scores and Lower Extremity Injury in NCAA Division I Athletes. Orthop J Sports Med. 2017 Aug 8;5(8):2325967117723666. doi: 10.1177/2325967117723666. eCollection 2017 Aug.

    PMID: 28840153BACKGROUND
  • Williams W, Selkow NM. Self-Myofascial Release of the Superficial Back Line Improves Sit-and-Reach Distance. J Sport Rehabil. 2019 Oct 18;29(4):400-404. doi: 10.1123/jsr.2018-0306. Print 2020 May 1.

    PMID: 30860410BACKGROUND
  • Gonzalo-Skok O, Sanchez-Sabate J, Izquierdo-Lupon L, Saez de Villarreal E. Influence of force-vector and force application plyometric training in young elite basketball players. Eur J Sport Sci. 2019 Apr;19(3):305-314. doi: 10.1080/17461391.2018.1502357. Epub 2018 Jul 28.

    PMID: 30058461BACKGROUND
  • Soulard J, Vaillant J, Balaguier R, Vuillerme N. Spatio-temporal gait parameters obtained from foot-worn inertial sensors are reliable in healthy adults in single- and dual-task conditions. Sci Rep. 2021 May 13;11(1):10229. doi: 10.1038/s41598-021-88794-4.

    PMID: 33986307BACKGROUND

MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

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

Study Officials

  • Tuğba Ulusoy, PT, MSc

    Ankara Yildirim Beyazıt University

    PRINCIPAL INVESTIGATOR
  • Ertuğrul Demirdel, Assoc.prof.

    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; participants were randomly allocated to Group 1 \[Foam Roller+Foot Core Exercises\] and Group 2 \[Foot Core Exercises\]
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 4, 2023

First Posted

March 17, 2023

Study Start

March 20, 2023

Primary Completion

May 26, 2023

Study Completion

June 9, 2023

Last Updated

October 10, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations