Clinical trial NCT05877482: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Flexible Flatfoot
Keywords: Short foot exercises
Pes Planus
Flat Feet
Insoles
Foot Posture Index
Navicular drop test
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 26
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Navicular Drop (ND) test for inclusion criteria
timeFrame: 1st week
Secondary outcomes:
measure: Six item Foot Posture Index (FPI)
timeFrame: 6th week
measure: Pain and disability were assessed by pain and disability subscales (both include 9 items) of the Foot Function Index (FFI)
timeFrame: 6th week
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Children Hospital Lahore
state: Punjab
Study officials:
affiliation: Riphah International University
name: Dr. Arnab Altaf, BSPT,Mphil
role: PRINCIPAL_INVESTIGATOR
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