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Completed

NCT Number: NCT04179591

Effects of Exercise and Insole on Foot Posture, Plantar Force Distribution, and Balance in Individuals With Pes Planus

The aim is to compare the effects of intrinsic foot muscles and tibialis posterior strengthening exercise, and customized arch support insoles on foot posture, plantar force distribution, and balance in individuals with flexible pes planus.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dokuz Eylul University, Institute of Health Sciences

Izmir, 35340, Turkey (Türkiye)

About this study

The aim is to compare the effects of intrinsic foot muscles and tibialis posterior strengthening exercise, and customized arch support insoles on foot posture, plantar force distribution, and balance in individuals with flexible pes planus. Forty-two individuals with flexible pes planus will be recruited into the study according to the inclusion criteria. Participants will be randomly divided into three groups: (1) Exercise, (2) Insole, (3) Exercise plus Insole. Exercises will be performed three times per week for six weeks, also custom-made insoles will be worn for six weeks. Foot posture will be assessed using the Navicular drop, Valgus index and Foot posture index-6. Plantar force variables will be recorded by the pressure-sensitive mat (HR Mat, Tekscan, USA) mounted in the middle of the 6-meter walkway in three sessions: (1) Upright standing, (2) Walking at different speeds: self-selected slow, normal and fast speeds, (3) Walking just after the heel-rise test for endurance. Balance performance will be assessed by the Balance Master System (NeuroCom® International Inc., USA). The assessments will be made pre/post intervention and at 6-weeks follow-up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • being between 18 and 40 years of age,
  • having Navicular drop test greater than 10 mm,
  • having Foot posture index-6 greater than or equal to 6,
  • having bilateral flexible pes planus.

Exclusion criteria

  • a lack of anatomical integrity of the foot,
  • a history of surgery or trauma in the foot region,
  • other musculoskeletal or neurological problems which may affect balance and gait performance.
  • having received any treatment for lower extremity disorders including pes planus within the last 1 year
  • having a body mass index equal to or greater than 30.

Treatment and study plan

Exercise

Other

Intrinsic foot muscles and tibialis posterior strengthening exercises

Orthesis

Other

Customized arch support insoles

Primary outcomes

  1. Foot posture

    Time frame: Change in foot posture measures from baseline to six weeks and to twelve weeks

    Foot posture will be assessed using the Navicular drop, Valgus index and Foot posture index-6.

  2. Balance

    Time frame: Change in balance scores from baseline to six weeks and to twelve weeks

    Balance performance will be assessed by the Balance Master System (NeuroCom® International Inc., USA).

  3. Plantar force variables

    Time frame: Change in plantar pressure variables from baseline to six weeks and to twelve weeks

    Plantar force variables will be recorded by the pressure-sensitive mat (HR Mat, Tekscan, USA) mounted in the middle of the 6-meter walkway in three sessions: (1) Upright standing, (2) Walking at different speeds: self-selected slow, normal, and fast speeds, (3) Walking just after the heel-rise test for endurance.

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Official study title

Comparison of the Effects of Foot Exercise Program and Arch Support Insoles on Foot Posture, Plantar Force Distribution, and Balance in Individuals With Flexible Pes Planus

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 27, 2019
Registry last updated
Jan 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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