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Pediatric Pes Planus: Effect of Insoles With and Without SFE

Primary Purpose

Flexible Flatfoot

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Short foot exercises
Insoles
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Flexible Flatfoot focused on measuring Short foot exercises, Pes Planus, Flat Feet, Insoles, Foot Posture Index, Navicular drop test

Eligibility Criteria

8 Years - 16 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Children Hospital LahoreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 18, 2023
Last Updated
May 18, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05877482
Brief Title
Pediatric Pes Planus: Effect of Insoles With and Without SFE
Official Title
Effect of Insoles With and Without Short Foot Exercises on Pain, Disability and Foot Posture in Children With Pes Planus
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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: 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flexible Flatfoot
Keywords
Short foot exercises, Pes Planus, Flat Feet, Insoles, Foot Posture Index, Navicular drop test

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Group assignment and short foot exercises training was conducted by the second physical therapist to provide blindness.
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Short foot exercises with internal shoe modification (a medial longitudinal arch support) will be performed daily for six weeks.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Only internal shoe modification will be performed by placing a medial longitudinal arch support insoles inside the shoe.
Intervention Type
Other
Intervention Name(s)
Short foot exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Insoles
Intervention Description
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.
Primary Outcome Measure Information:
Title
Navicular Drop (ND) test for inclusion criteria
Description
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.
Time Frame
1st week
Secondary Outcome Measure Information:
Title
Six item Foot Posture Index (FPI)
Description
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.
Time Frame
6th week
Title
Pain and disability were assessed by pain and disability subscales (both include 9 items) of the Foot Function Index (FFI)
Description
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.
Time Frame
6th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Arnab Altaf, BSPT,MPhil
Phone
03064585776
Email
arnab.altaf@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Muneeb Khan, Ph.D.
Phone
03367993611
Email
muneeb.khan@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Arnab Altaf, BSPT,Mphil
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children Hospital Lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eram Aslam, MS
Phone
03367034716
Email
doctor.eram786@gmail.com
First Name & Middle Initial & Last Name & Degree
Eram Aslam, MS

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28144575
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
33184442
Citation
Acak M. The effects of individually designed insoles on pes planus treatment. Sci Rep. 2020 Nov 12;10(1):19715. doi: 10.1038/s41598-020-76767-y.
Results Reference
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PubMed Identifier
20646107
Citation
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PubMed Identifier
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Citation
Chevalier TL, Chockalingam N. Effects of foot orthoses: How important is the practitioner? Gait Posture. 2012 Mar;35(3):383-8. doi: 10.1016/j.gaitpost.2011.10.356. Epub 2011 Nov 21.
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Citation
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Citation
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Citation
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Pediatric Pes Planus: Effect of Insoles With and Without SFE

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