Semirigid insole for correcting flexible flatfeet

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-site interventional study will enroll 30 adults aged 18–35 with asymptomatic flexible pes planus confirmed by the navicular drop test and the Foot Posture Index. Each participant will have weight-bearing anteroposterior and lateral foot X-rays taken once standing barefoot and once standing on a semirigid insole, with angles measured manually using a ruler and protractor. People with symptomatic pain >3/10, foot osteoarthritis, structural deformities, prior foot fractures or lower-limb surgery, ligament tears, systemic inflammatory diseases, or neurological disorders are excluded. The trial compares radiographic angle differences between barefoot and insole conditions to see if the insole produces immediate alignment changes.

Why it matters

Who can join: the full rules

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.

Where it's running

• October 6 University Hospital
  Giza, Egypt Recruiting

Study contacts

• Principal investigator: Fatma Elzahraa A ElBayomi, MSc degree — Cairo University
• Study coordinator: Fatma Elzahraa A ElBayomi, MSc degree
• Email: fatmaelzahraaelbayomi@gmail.com
• Phone: +201140015529

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.