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

Pes Planus Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04179591
• Other study ID #: Müge KIRMIZI
• Status: Completed
• Phase: N/A
• Start date: November 30, 2019
• Est. completion date: July 26, 2021

Study information

• Verified date: December 2021
• Source: Dokuz Eylul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 26, 2021
• Est. primary completion date: July 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Flatfoot
• Pes Planus

Intervention

Other:
• Exercise
Intrinsic foot muscles and tibialis posterior strengthening exercises
• Orthesis
Customized arch support insoles

Locations

Country	Name	City	State
Turkey	Dokuz Eylul University, Institute of Health Sciences	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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