Pediatric Pes Planus: Effect of Insoles With & Without SFE

Status Recruiting

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05877482
Study type	Interventional
Source	Riphah International University
Contact	Dr Arnab Altaf, BSPT,MPhil
Phone	03064585776
Email	arnab.altaf@riphah.edu.pk
Status	Recruiting
Phase	N/A
Start date	March 1, 2023
Completion date	September 1, 2023

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Pediatric Pes Planus: Effect of Insoles With and Without SFE

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms