NCT05437042

Brief Summary

The use of heel wedges is often recommended as a clinical routine in individuals with foot pronation. However, there is a lack of information for examining the immediate effect of supports used to restore foot biomechanics on balance. The aim of our study is to examine the immediate effect of calcaneal support in the frontal plane on static balance in individuals with increased pronated foot. In this study, the fore-hind foot load distribution in static bipedal stance will be examined in healthy young adults. Then, static balance measurements will be made on one leg with and without support (medial heel wedge). For the evaluation of static balance on one leg, x-y mean, ellipse surface, A-P index measurements and romberg test will be used. In addition, the pain of individuals will be questioned and their foot postures will be evaluated. Healthy young adult individuals with a subtalar angle of 5 degrees and above in the weighted position will be included in the evaluations. Evaluations of the participants are planned to take approximately 15 minutes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

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

Study Start

First participant enrolled

April 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 29, 2022

Completed
Last Updated

July 6, 2022

Status Verified

July 1, 2022

Enrollment Period

9 months

First QC Date

June 23, 2022

Last Update Submit

July 1, 2022

Conditions

Keywords

Foot OrthosesPostural BalanceSubtalar Joint

Outcome Measures

Primary Outcomes (1)

  • Immediate effect of medial heel wedge on static balance

    Day 1

Secondary Outcomes (1)

  • Immediate effect of medial heel wedge on load distribution

    Day 1

Study Arms (1)

Individuals with pronated foot

Other: Medial calcaneal wedge

Interventions

Immediate effect of medial calcaneal wedge for static balance and weight distribution

Individuals with pronated foot

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Young adults who has pronated foot

You may qualify if:

  • Standing subtalar angle of 5° or more
  • Foot Posture Index score of 6 or more
  • Right lower limb dominance
  • Agreeing to participate in the study voluntarily

You may not qualify if:

  • Having a neurological or orthopedic problem
  • Having any surgery on the lower extremity
  • Having a foot-ankle complex Visual Analog Scale (VAS) pain score above 6.4

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Ankara, Sıhhiye, Turkey (Türkiye)

Location

Related Publications (9)

  • Leung AK, Mak AF, Evans JH. Biomedical gait evaluation of the immediate effect of orthotic treatment for flexible flat foot. Prosthet Orthot Int. 1998 Apr;22(1):25-34. doi: 10.3109/03093649809164454.

    PMID: 9604273BACKGROUND
  • McPoil TG, Hunt GC. Evaluation and management of foot and ankle disorders: present problems and future directions. J Orthop Sports Phys Ther. 1995 Jun;21(6):381-8. doi: 10.2519/jospt.1995.21.6.381.

    PMID: 7655482BACKGROUND
  • Valmassy RL. clinical biomechanics of the lower extermities. Mosby, Missouri. 1996;12:143-5.

    BACKGROUND
  • Kararti C, Bilgin S, Buyukturan O, Buyukturan B. Arka Ayaktaki Pronasyon Artisinin Fiziksel Performans Uzerine Etkisi. Hacettepe University Faculty of Health Sciences Journal. 2018;5(1):1-0.

    BACKGROUND
  • Hadley A, Griffiths S, Griffiths L, Vicenzino B. Antipronation taping and temporary orthoses. Effects on tibial rotation position after exercise. J Am Podiatr Med Assoc. 1999 Mar;89(3):118-23. doi: 10.7547/87507315-89-3-118.

    PMID: 10095333BACKGROUND
  • Al Abdulwahab SS, Kachanathu SJ. The effect of various degrees of foot posture on standing balance in a healthy adult population. Somatosens Mot Res. 2015;32(3):172-6. doi: 10.3109/08990220.2015.1029608. Epub 2015 Sep 7.

    PMID: 26400632BACKGROUND
  • Winter DA. Human balance and posture control during standing and walking. Gait & posture. 1995 Dec 1;3(4):193-214.

    BACKGROUND
  • Whitney KA. Foot deformities, biomechanical and pathomechanical changes associated with aging including orthotic considerations, Part II. Clin Podiatr Med Surg. 2003 Jul;20(3):511-26, x. doi: 10.1016/S0891-8422(03)00046-6.

    PMID: 12952051BACKGROUND
  • Borklu T, Dolu N. Sporcularda Isitsel Uyarilma Potansiyellerindeki Hemisferik Farkliliklar. Sağlık Bilimleri Dergisi (Journal of Health Sciences). 2010;19(2):108-18.

    BACKGROUND

MeSH Terms

Conditions

Congenital AbnormalitiesGenu ValgumFoot DeformitiesFlatfoot

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesBone DiseasesMusculoskeletal DiseasesTalipesFoot Deformities, AcquiredFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal Abnormalities

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

June 23, 2022

First Posted

June 29, 2022

Study Start

April 1, 2021

Primary Completion

December 31, 2021

Study Completion

January 1, 2022

Last Updated

July 6, 2022

Record last verified: 2022-07

Locations