Effect of a Semirigid Foot Insole in Flexible Pes Planus

NCT07389343 | Recruiting DMC

• 1 other identifier: Fatma-PhD
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate the effect of a semirigid foot insole on radiological angle correction in people with asymptomatic flexible flat feet. The X-ray will be performed while standing barefoot one time and the other while standing on the insole from 2 views.

Conditions

Flexible Flatfoot or Pes Planus

Keywords

"Foot insole" and "Flexible flatfoot" and "radiological foot angles"

Outcome Measures

Primary Outcomes (1)

• Radiological foot angles

  In the lateral view,the lateral talo-1st metatarsal angle, the calcaneal inclination angle, the angle of Hibbs, the calcaneal-5th metatarsal angle, and the navicular height. In the AP view,The lateral talo-1st metatarsal angle, Talo-2nd metatarsal angle, The talocalcaneal angle, Talonavicular coverage angle and First-fifth metatarsal angle

  Immediately after the insole insertion. The radiology will be taken one time barefoot and second time with the insole insertion, and the researcher will measure the foot angles pre- and post-insole to measure the correction.

Study Arms (1)

Semirigid foot insole

EXPERIMENTAL

A semi-rigidly designed foot insole will be used to investigate the correction provided for flat-foot angles.

Other: Foot Insole

Interventions

Foot Insole OTHER

Designed Semirigid foot insole

Semirigid foot insole

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Asymptomatic people with flexible pes planus. If the pain is greater than 3 out of 10 on the visual analog scale in the last 3 months, the patient is considered to have symptomatic flat feet (Mahdiyar et al., 2021).
• Aged 18-35.
• BMI max 29.9 kg/cm².

You may not qualify if:

• Osteoarthritis of the joints of the foot (excluded by x-ray).
• Foot Deformities (e.g. Hallux Valgus)
• Old fractures of the foot.
• Previous injuries to the ankle.
• Previous surgeries to the lower limb. 6. Calcaneal Spur. 7. Foot and ankle ligaments tear.
• Systemic diseases such as rheumatoid arthritis. (Gouty arthritis, autoimmune disease) 9. Neurological diseases.

Sponsors & Collaborators

• Fatma El Zahraa: lead

Study Sites (1)

October 6 University Hospital

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Flatfoot

Interventions

Foot Orthoses

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)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Fatma Elzahraa A ElBayomi, MSc degree

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatma Elzahraa A ElBayomi, MSc degree

CONTACT

+201140015529; fatmaelzahraaelbayomi@gmail.com

Mona M Ibrahim, Asst. Prof.

CONTACT

+201004046183; mona.ibrahiem@pt.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: lecturer assistant at faculty of physical therapy-Ahram Canadian University AND PHD candidate at Faculty of physical therapy

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: February 5, 2026
• Study Start: August 27, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)