Pediatric Pes Planus: Effect of Insoles With and Without SFE

Study Overview
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Brief Summary
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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: What are the effects of insoles on pain, disability, and foot posture in children with pes planus? What are the effects of short foot exercises on pain, disability, and foot posture in children with pes planus? What are the combined effects of insoles and short foot exercises on pain, disability, and foot posture in children with pes planus? 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.

Detailed Description
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All participants will be informed about the study, and an informed consent form was signed by each participant. A total of 26 participants with pes planus will be assigned, to the short-foot exercises group (n = 13) and the control group (n = 13). Both groups will be informed about pes planus, usual foot care, and appropriate footwear with individually designed foot insoles. In experimental group Short foot exercises (SFE) and internal shoe modification will be performed by placing an individually designed medial longitudinal arch support insoles inside the shoe. Exercises will be performed daily for six weeks. While in control group only internal shoe modification will be performed. Short-foot exercises group will be performed the exercises daily for 6 weeks. Normality of data checked by the Shapiro wilk test. If the P-value is more than 0.05 then para metric test will applied and if P value is less than 0.05 than it is non-parametric. SPSS version 25.0 statistical software will be used. This study will examine the effects of individually designed insole in pes planus treatment with and without short foot exercises to improve the physical performance parameters and minimize the complaints of the individuals with pes planus.

Official Title
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Effect of Insoles With and Without Short Foot Exercises on Pain, Disability and Foot Posture in Children With Pes Planus

Conditions
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Flexible Flatfoot

Intervention / Treatment
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* Other: Short foot exercises
* Other: Insoles


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Short foot exercises with internal shoe modification (a medial longitudinal arch support) will be performed daily for six weeks. | Other: Short foot exercises<br>* A total of 26 participants with pes planus were assigned to the short-foot exercises group (n = 13) and the control group (n = 13). Both groups will be informed about pes planus, usual foot care, and appropriate footwear with foot insoles. In experimental group Short foot exercises (SFE) and internal shoe modification will be performed by placing a medial longitudinal arch support insoles inside the shoe. Exercises will be performed daily for six weeks.<br>Other: Insoles<br>* In control group only internal shoe modification will be performed by placing medial longitudinal arch support insoles inside the shoe. Group assignment and SFE training will be conducted by the second physical therapist to provide blindness.<br>|
| No Intervention: Control Group<br>Only internal shoe modification will be performed by placing a medial longitudinal arch support insoles inside the shoe. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Navicular Drop (ND) test for inclusion criteria | The Navicular Drop Test (NDT) was first described by Brody in 1982 as a means of quantifying the amount of foot pronation in runners. It is the one of the static foot assessment tool and is intended to represent the sagittal plane displacement of the navicular tuberosity from a neutral position i.e. Subtalar joint neutral to a relaxed position in standing. | 1st week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six item Foot Posture Index (FPI) | The FPI-6 is a novel method of rating foot posture using set criteria and a simple scale. It is a clinical tool used to quantify the degree to which a foot is pronated, neutral or supinated. It is a measure of standing foot posture and so is not a replacement for gait assessment where time and facilities exist. It is however a more valid approach than many of the static weight bearing and non-weight bearing goniometric measures currently used in clinic. | 6th week | 
| Pain and disability were assessed by pain and disability subscales (both include 9 items) of the Foot Function Index (FFI) | A Foot Function Index (FFI) was developed in 1991 to measure the impact of foot pathology on function in terms of pain, disability and activity restriction. [1] It is a self-administered index consisting of 23 items divided into 3 sub-scales. Both total and sub-scale scores are produced. | 6th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Short foot exercises, Pes Planus, Flat Feet, Insoles, Foot Posture Index, Navicular drop test