Foot and Lower Extremity Exercises in Adolescents With Pes Planovalgus

September 13, 2023 updated by: Halenur Evrendilek

Comparison of the Effects of Foot and Lower Extremity Strengthening Exercises in Adolescents With Pes Planovalgus

The study aims to determine and compare the effects of 8-week intrinsic foot muscle-strengthening exercises and lower extremity strengthening exercises in adolescents with pes planovalgus.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age between the 12-18 years,
  • Foot posture index-6 score > 6,
  • Navicular drop test value > 1 cm,
  • Body mass index between 18.5 - 25 kg/m2,
  • Children with flexible pes planovalgus

Exclusion Criteria:

  • Presence of any pathology that prevents participation in exercises
  • Diagnosis of any neurological, psychological, or metabolic disease
  • History of orthopedic surgery
  • Use of insoles in the last 1 year
  • Leg length discrepancy and scoliosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group (CG)
Active Comparator: Foot Exercise Group (FEG)
Other: Foot exercise
This group will engage in an 8-week foot intrinsic strengthening training
Active Comparator: Lower Extremity Exercise Group (LEEG)
Other: Lower Extremity Exercise
This group will engage in an 8-week lower extremity strengthening training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Foot posture assesment
Time Frame: Pre-intervention assesment and after 8-week
Foot Posture Index 6 and navicular drop will be used for assesing the foot pronation.
Pre-intervention assesment and after 8-week
Foot muscle strentgh assesment
Time Frame: Pre-intervention assesment and after 8-week
Toe muscle strength will be assessed through the utilization of a handheld dynamometer.
Pre-intervention assesment and after 8-week
Performance and dynamic balance assesment
Time Frame: Pre-intervention assesment and after 8-week
Front jump test and star excursion balance test will be performed by participants.
Pre-intervention assesment and after 8-week
3D gait analysis
Time Frame: Pre-intervention assesment and after 8-week
The kinetic/kinematic analysis of the foot and the lower extremity will be conducted using a motion capture system, specifically employing the Oxford Foot Model and the Plug-in Gait Model.
Pre-intervention assesment and after 8-week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional assesment
Time Frame: Pre-intervention assesment and after 8-week
The Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) will be utilized for function-related aspect.
Pre-intervention assesment and after 8-week
Quality of life assesment
Time Frame: Pre-intervention assesment and after 8-week
Pediatric Quality of Life Inventory (PedsQL) will be utilized for the assessment of participants' quality of life status.
Pre-intervention assesment and after 8-week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Halenur Evrendilek

Investigators

  • Principal Investigator: Halenur Evrendilek, MSc, PhD (c), Istanbul University - Cerrahpasa (IUC)
  • Study Director: Derya Çelik, Prof. Dr., Istanbul University - Cerrahpasa (IUC)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

September 13, 2023

First Submitted That Met QC Criteria

September 13, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 13, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/52

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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