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Clinical Trials/NCT05877482
NCT05877482
Recruiting
Not Applicable

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

Riphah International University1 site in 1 country26 target enrollmentMarch 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Flexible Flatfoot
Sponsor
Riphah International University
Enrollment
26
Locations
1
Primary Endpoint
Navicular Drop (ND) test for inclusion criteria
Status
Recruiting
Last Updated
2 years ago

Overview

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. 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.

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2023
End Date
September 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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 Sites (1)

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