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

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

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.

Study Overview

• Status: Completed
• Conditions: Pes Planus
• Intervention / Treatment: Other: Exercise; Other: Orthesis

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Izmir, Turkey, 35340
    • Dokuz Eylul University, Institute of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dokuz Eylul University

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2019
• Primary Completion (Actual): July 26, 2021
• Study Completion (Actual): July 26, 2021

Study Registration Dates

• First Submitted: November 24, 2019
• First Submitted That Met QC Criteria: November 25, 2019
• First Posted (Actual): November 27, 2019

Study Record Updates

• Last Update Posted (Actual): January 3, 2022
• Last Update Submitted That Met QC Criteria: December 12, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Balance; Pes planus; Foot posture; Plantar pressure variables; Short foot exercises; Tibials posterior strengthening; Intrinsic foot muscles; Custom-made insole; Arch support insole
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Talipes; Flatfoot
• Other Study ID Numbers: Müge KIRMIZI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No