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

Primary Purpose

Pes Planus

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise
Orthesis
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pes Planus focused on measuring Pes planus, Foot posture, Plantar pressure variables, Balance, Short foot exercises, Tibials posterior strengthening, Intrinsic foot muscles, Custom-made insole, Arch support insole

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dokuz Eylul University, Institute of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Exercise

Insole

Exercise plus Insole

Arm Description

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

Customized arch support insoles will be worn for six weeks.

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

Outcomes

Primary Outcome Measures

Foot posture
Foot posture will be assessed using the Navicular drop, Valgus index and Foot posture index-6.
Balance
Balance performance will be assessed by the Balance Master System (NeuroCom® International Inc., USA).
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.

Secondary Outcome Measures

Full Information

First Posted
November 24, 2019
Last Updated
December 12, 2021
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT04179591
Brief Title
Effects of Exercise and Insole on Foot Posture, Plantar Force Distribution, and Balance in Individuals With Pes Planus
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
November 30, 2019 (Actual)
Primary Completion Date
July 26, 2021 (Actual)
Study Completion Date
July 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pes Planus
Keywords
Pes planus, Foot posture, Plantar pressure variables, Balance, Short foot exercises, Tibials posterior strengthening, Intrinsic foot muscles, Custom-made insole, Arch support insole

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
Exercises will be performed three times per week for six weeks.
Arm Title
Insole
Arm Type
Experimental
Arm Description
Customized arch support insoles will be worn for six weeks.
Arm Title
Exercise plus Insole
Arm Type
Experimental
Arm Description
Exercises will be performed three times per week, and customized arch support will be worn for six weeks.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Intrinsic foot muscles and tibialis posterior strengthening exercises
Intervention Type
Other
Intervention Name(s)
Orthesis
Intervention Description
Customized arch support insoles
Primary Outcome Measure Information:
Title
Foot posture
Description
Foot posture will be assessed using the Navicular drop, Valgus index and Foot posture index-6.
Time Frame
Change in foot posture measures from baseline to six weeks and to twelve weeks
Title
Balance
Description
Balance performance will be assessed by the Balance Master System (NeuroCom® International Inc., USA).
Time Frame
Change in balance scores from baseline to six weeks and to twelve weeks
Title
Plantar force variables
Description
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.
Time Frame
Change in plantar pressure variables from baseline to six weeks and to twelve weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Dokuz Eylul University, Institute of Health Sciences
City
Izmir
ZIP/Postal Code
35340
Country
Turkey

12. IPD Sharing Statement

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

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