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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Pes Planus

Intervention / Treatment
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* Other: Exercise
* Other: Orthesis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>Exercises will be performed three times per week for six weeks. | Other: Exercise<br>* Intrinsic foot muscles and tibialis posterior strengthening exercises<br>|
| Experimental: Insole<br>Customized arch support insoles will be worn for six weeks. | Other: Orthesis<br>* Customized arch support insoles<br>|
| Experimental: Exercise plus Insole<br>Exercises will be performed three times per week, and customized arch support will be worn for six weeks. | Other: Exercise<br>* Intrinsic foot muscles and tibialis posterior strengthening exercises<br>Other: Orthesis<br>* Customized arch support insoles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foot posture | Foot posture will be assessed using the Navicular drop, Valgus index and Foot posture index-6. | Change in foot posture measures from baseline to six weeks and to twelve weeks | 
| Balance | Balance performance will be assessed by the Balance Master System (NeuroCom® International Inc., USA). | Change in balance scores from baseline to six weeks and to twelve weeks | 
| Plantar force variables | 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. | Change in plantar pressure variables from baseline to six weeks and to twelve weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pes planus, Foot posture, Plantar pressure variables, Balance, Short foot exercises, Tibials posterior strengthening, Intrinsic foot muscles, Custom-made insole, Arch support insole