Pediatric Pes Planus: Effect of Insoles With and Without SFE

NCT05877482 | Unknown

• 1 other identifier: REC/RCR & AHS/22/0719
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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:

1. 1.What are the effects of insoles on pain, disability, and foot posture in children with pes planus?
2. 2.What are the effects of short foot exercises on pain, disability, and foot posture in children with pes planus?
3. 3.What are the combined effects of insoles and short foot exercises on pain, disability, and foot posture in children with pes planus?
4. 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?

Conditions

Flexible Flatfoot

Keywords

Short foot exercises; Pes Planus; Flat Feet; Insoles; Foot Posture Index; Navicular drop test

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Six item Foot Posture Index (FPI)

  6th week

• Pain and disability were assessed by pain and disability subscales (both include 9 items) of the Foot Function Index (FFI)

  6th week

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Other: Short foot exercises; Other: Insoles

Control Group

NO INTERVENTION

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

Interventions

Short foot exercises OTHER

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.

Experimental Group

Insoles OTHER

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.

Experimental Group

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Having bilateral pes planus according to Navicular Drop (ND) exceeding 10 mm
• six item Foot Posture Index (FPI) score 6 to 12

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Children Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (12)

• Alazzawi S, Sukeik M, King D, Vemulapalli K. Foot and ankle history and clinical examination: A guide to everyday practice. World J Orthop. 2017 Jan 18;8(1):21-29. doi: 10.5312/wjo.v8.i1.21. eCollection 2017 Jan 18.

  PMID: 28144575 BACKGROUND

• Gwani AS, Asari MA, Mohd Ismail ZI. How the three arches of the foot intercorrelate. Folia Morphol (Warsz). 2017;76(4):682-688. doi: 10.5603/FM.a2017.0049. Epub 2017 May 29.

  PMID: 28553850 BACKGROUND

• 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.

  PMID: 33184442 BACKGROUND

• Caravaggi P, Pataky T, Gunther M, Savage R, Crompton R. Dynamics of longitudinal arch support in relation to walking speed: contribution of the plantar aponeurosis. J Anat. 2010 Sep;217(3):254-61. doi: 10.1111/j.1469-7580.2010.01261.x. Epub 2010 Jul 14.

  PMID: 20646107 BACKGROUND

• Hashimoto T, Sakuraba K. Strength training for the intrinsic flexor muscles of the foot: effects on muscle strength, the foot arch, and dynamic parameters before and after the training. J Phys Ther Sci. 2014 Mar;26(3):373-6. doi: 10.1589/jpts.26.373. Epub 2014 Mar 25.

  PMID: 24707086 BACKGROUND

• McCormack AP, Ching RP, Sangeorzan BJ. Biomechanics of procedures used in adult flatfoot deformity. Foot Ankle Clin. 2001 Mar;6(1):15-23, v. doi: 10.1016/s1083-7515(03)00072-x.

  PMID: 11385922 BACKGROUND

• 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.

  PMID: 22104292 BACKGROUND

• Nawoczenski DA, Saltzman CL, Cook TM. The effect of foot structure on the three-dimensional kinematic coupling behavior of the leg and rear foot. Phys Ther. 1998 Apr;78(4):404-16. doi: 10.1093/ptj/78.4.404.

  PMID: 9555923 BACKGROUND

• Yurt Y, Sener G, Yakut Y. The effect of different foot orthoses on pain and health related quality of life in painful flexible flat foot: a randomized controlled trial. Eur J Phys Rehabil Med. 2019 Feb;55(1):95-102. doi: 10.23736/S1973-9087.18.05108-0. Epub 2018 Mar 16.

  PMID: 29553223 BACKGROUND

• Unver B, Erdem EU, Akbas E. Effects of Short-Foot Exercises on Foot Posture, Pain, Disability, and Plantar Pressure in Pes Planus. J Sport Rehabil. 2019 Oct 18;29(4):436-440. doi: 10.1123/jsr.2018-0363. Print 2020 May 1.

  PMID: 30860412 BACKGROUND

• Yildirim Sahan T, Aydogan Arslan S, Demirci C, Oktas B, Sertel M. Comparison Of Short-Term Effects Of Virtual Reality and Short Foot Exercises In Pes Planus. Foot (Edinb). 2021 Jun;47:101778. doi: 10.1016/j.foot.2021.101778. Epub 2021 Jan 21.

  PMID: 33962115 BACKGROUND

• Taspinar O, Kabayel DD, Ozdemir F, Tuna H, Keskin Y, Mercimek OB, Sut N, Yavuz S, Tuna F. Comparing the efficacy of exercise, internal and external shoe modification in pes planus: A clinical and pedobarographic study. J Back Musculoskelet Rehabil. 2017;30(2):255-263. doi: 10.3233/BMR-150399.

  PMID: 27858680 BACKGROUND

MeSH Terms

Conditions

Flatfoot

Interventions

Foot Orthoses

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Dr. Arnab Altaf, BSPT,Mphil

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Arnab Altaf, BSPT,MPhil

CONTACT

03064585776; arnab.altaf@riphah.edu.pk

Dr. Muneeb Khan, Ph.D.

CONTACT

03367993611; muneeb.khan@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Group assignment and short foot exercises training was conducted by the second physical therapist to provide blindness.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: May 26, 2023
• Study Start: March 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: September 1, 2023
• Last Updated: May 26, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)