Pediatric Pes Planus: Effect of Insoles With and Without SFE

May 18, 2023 updated by: Riphah International University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Recruiting
        • Children Hospital Lahore
        • Contact:
        • Principal Investigator:
          • Eram Aslam, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Navicular Drop (ND) test for inclusion criteria
Time Frame: 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.
1st week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Six item Foot Posture Index (FPI)
Time Frame: 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.
6th week
Pain and disability were assessed by pain and disability subscales (both include 9 items) of the Foot Function Index (FFI)
Time Frame: 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.
6th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Dr. Arnab Altaf, BSPT,Mphil, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Estimated)

August 1, 2023

Study Completion (Estimated)

September 1, 2023

Study Registration Dates

First Submitted

May 18, 2023

First Submitted That Met QC Criteria

May 18, 2023

First Posted (Actual)

May 26, 2023

Study Record Updates

Last Update Posted (Actual)

May 26, 2023

Last Update Submitted That Met QC Criteria

May 18, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR & AHS/22/0719

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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