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

NCT04179591 | Completed DMC

• 1 other identifier: Müge KIRMIZI
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Exercise

EXPERIMENTAL

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

Other: Exercise

Insole

EXPERIMENTAL

Customized arch support insoles will be worn for six weeks.

Other: Orthesis

Exercise plus Insole

EXPERIMENTAL

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

Other: Exercise; Other: Orthesis

Interventions

Exercise OTHER

Intrinsic foot muscles and tibialis posterior strengthening exercises

Exercise; Exercise plus Insole

Orthesis OTHER

Customized arch support insoles

Exercise plus Insole; Insole

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylul University, Institute of Health Sciences

Izmir, 35340, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Flatfoot

Interventions

Exercise

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: November 24, 2019
• First Posted: November 27, 2019
• Study Start: November 30, 2019
• Primary Completion: July 26, 2021
• Study Completion: July 26, 2021
• Last Updated: January 3, 2022

Record last verified: 2021-12

Locations

TU (1)