UnknownNot Applicable

Pediatric Pes Planus: Effect of Insoles With and Without SFE

Pakistan26 participantsStarted 2023-03-01

Plain-language summary

The goal of this randomised control trial is to determine the effects of insoles with and without short foot exercises on pain, disability and foot posture in children with pes planus. The main question\[s\] it aims to answer are: 1. What are the effects of insoles on pain, disability, and foot posture in children with pes planus? 2. What are the effects of short foot exercises on pain, disability, and foot posture in children with pes planus? 3. What are the combined effects of insoles and short foot exercises on pain, disability, and foot posture in children with pes planus? 4. Is there a significant difference between the effects of insoles alone versus insoles with short foot exercises on pain, disability, and foot posture in children with pes planus? Participants will be asked to signed consent form and divided into two groups. Experimental group will be asked to performed short foot exercises with internal shoe modification (a medial longitudinal arch support) daily for six weeks and Control Group will be asked to perform only internal shoe modification by placing a medial longitudinal arch support insoles inside the shoe. Researchers will compare: 1\) Insoles only vs insoles + short foot exercises: This comparison would involve evaluating the effects of wearing insoles alone compared to wearing insoles and performing short foot exercises together to see effect on pain, disability, and foot posture among pes planus children between age group of 08 to 16 years.

Who can participate

Age range

8 Years – 16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Having bilateral pes planus according to Navicular Drop (ND) exceeding 10 mm * six item Foot Posture Index (FPI) score 6 to 12 Exclusion Criteria: * Children having rigid pes planus, * Hallux valgus, * Hallux rigidus, * Epin calcanei, * Systemic, neurological or orthopedic problems that can affect the lower extremity, * History of surgery on the lower extremities. * Musculoskeletal pathologies, open wound in foot or a previous spinal/lower limb surgery

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Navicular Drop (ND) test for inclusion criteria

Timeframe: 1st week

Trial details

NCT IDNCT05877482

SponsorRiphah International University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-01

Contact for this trial

Dr Arnab Altaf, BSPT,MPhil

03064585776 arnab.altaf@riphah.edu.pk

View on ClinicalTrials.gov More Flexible Flatfoot trials