Effect of a Semirigid Foot Insole in Flexible Pes Planus

Immediate Effect of a Semirigid Foot Insole on Radiological Foot Angles in Flexible Pes Planus

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.

Study Overview

• Status: Recruiting
• Conditions: Flexible Flatfoot or Pes Planus
• Intervention / Treatment: Other: Foot Insole

Detailed Description

This study will be conducted on 30 male and female subjects with flexible pes planus. Clinical diagnosis for flexible pes planus will be made through the navicular drop test (NDT) and the Foot Posture Index (FPI). The study included asymptomatic people with flexible pes planus. If the pain is greater than 3 out of 10 on the numeric pain rating scale in the last 3 months, aged 18-35, and BMI max 29.9 kg/cm². The subjects will be excluded if they have 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, or previous surgeries to the lower limb. Calcaneal Spur, Foot and Ankle Ligament Tear, Systemic diseases such as rheumatoid arthritis (gouty arthritis, an autoimmune disease) and neurological diseases. The X-ray is the gold standard for assessment of adult-acquired flat foot deformity. Two views are used: anteroposterior (AP) and lateral views. A ruler and protractor will be used for manual measurements of X-ray foot. The subject will stand barefoot, and a weight-bearing X-ray will be taken from lateral and AP views once, without an insole, and another photo will be taken with an insole. The subject will stand barefoot, and a weight-bearing X-ray will be taken from lateral and AP views once, without an insole, and another photo will be taken with an insole.

The angles will be measured:

The gathered angles aim to evaluate the alignment of the foot's three arches. In the lateral view, the following angles will be measured and evaluated with without the insole: 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 following angles will be measured and evaluated with without the insole: The lateral talo-1st metatarsal angle, Talo-2nd metatarsal angle, The talocalcaneal angle, Talonavicular coverage angle and First-fifth metatarsal angle

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fatma Elzahraa A ElBayomi, MSc degree; Phone Number: +201140015529; Email: fatmaelzahraaelbayomi@gmail.com
• Study Contact Backup: Name: Mona M Ibrahim, Asst. Prof.; Phone Number: +201004046183; Email: mona.ibrahiem@pt.cu.edu.eg

Study Locations

• Egypt
  • Giza, Egypt
    • Recruiting
    • October 6 University Hospital
    • Contact: Fatma Elzahraa A ElBayomi, MSc degree; Phone Number: +201140015529; Email: fatmaelzahraaelbayomi@gmail.com
    • Contact: Mona M Ibrahim, Asst Prof.; Phone Number: +201004046183; Email: mona.ibrahiem@pt.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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).
2. Aged 18-35.
3. BMI max 29.9 kg/cm².

Exclusion Criteria:

1. Osteoarthritis of the joints of the foot (excluded by x-ray).
2. Foot Deformities (e.g. Hallux Valgus)
3. Old fractures of the foot.
4. Previous injuries to the ankle.
5. Previous surgeries to the lower limb. 6. Calcaneal Spur. 7. Foot and ankle ligaments tear.

8- Systemic diseases such as rheumatoid arthritis. (Gouty arthritis, autoimmune disease) 9. Neurological diseases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Semirigid foot insole; A semi-rigidly designed foot insole will be used to investigate the correction provided for flat-foot angles.	Other: Foot Insole; Designed Semirigid foot insole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Fatma El Zahraa
• Investigators: Principal Investigator: Fatma Elzahraa A ElBayomi, MSc degree, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: January 23, 2026
• First Submitted That Met QC Criteria: January 31, 2026
• First Posted (Actual): February 5, 2026

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: January 31, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: "Foot insole" and "Flexible flatfoot" and "radiological foot angles"
• Additional Relevant MeSH Terms: Talipes; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Flatfoot; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Orthotic Devices; Foot Orthoses
• Other Study ID Numbers: Fatma-PhD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Obtaining the patient privacy, however the data will be available with the original author uopn request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No