Pediatric Pes Planus: Effect of Insoles With and Without SFE

Sponsor

Riphah International University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05877482

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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:

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:

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.

Condition or Disease	Intervention/Treatment	Phase
Flexible Flatfoot	Other: Short foot exercises Other: Insoles	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

Group assignment and short foot exercises training was conducted by the second physical therapist to provide blindness.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Group Short foot exercises with internal shoe modification (a medial longitudinal arch support) will be performed daily for six weeks.	Other: Short foot exercises 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. Other: Insoles 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.
No Intervention: Control Group Only internal shoe modification will be performed by placing a medial longitudinal arch support insoles inside the shoe.

Arm

Intervention/Treatment

Experimental: Experimental Group

Short foot exercises with internal shoe modification (a medial longitudinal arch support) will be performed daily for six weeks.

Other: Short foot exercises

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.

Other: Insoles

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.

No Intervention: Control Group

Only internal shoe modification will be performed by placing a medial longitudinal arch support insoles inside the shoe.

Outcome Measures

Primary Outcome Measures

Navicular Drop (ND) test for inclusion criteria [1st week]
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.

Secondary Outcome Measures

Six item Foot Posture Index (FPI) [6th week]
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.
Pain and disability were assessed by pain and disability subscales (both include 9 items) of the Foot Function Index (FFI) [6th week]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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