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Clinical Trials/NCT04179591
NCT04179591CompletedNot Applicable

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

Dokuz Eylul University1 site in 1 country40 target enrollmentStarted: November 30, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Foot posture

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Exercise

Experimental

Exercises will be performed three times per week for six weeks.

Intervention: Exercise (Other)

Insole

Experimental

Customized arch support insoles will be worn for six weeks.

Intervention: Orthesis (Other)

Exercise plus Insole

Experimental

Exercises will be performed three times per week, and customized arch support will be worn for six weeks.

Intervention: Exercise (Other)

Exercise plus Insole

Experimental

Exercises will be performed three times per week, and customized arch support will be worn for six weeks.

Intervention: Orthesis (Other)

Outcomes

Primary Outcomes

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.

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).

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Müge KIRMIZI

Research Assistant

Dokuz Eylul University

Study Sites (1)

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