The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Foot and Lower Extremity Exercises in Adolescents With Pes Planovalgus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06045208
Recruitment Status : Not yet recruiting
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
Sponsor:
Information provided by (Responsible Party):
Halenur Evrendilek, Istanbul Kültür University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Flat Foot Other: Foot exercise Other: Lower Extremity Exercise Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of the Effects of Foot and Lower Extremity Strengthening Exercises in Adolescents With Pes Planovalgus
Estimated Study Start Date : October 2023
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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
No Intervention: Control Group (CG)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06045208


Contacts
Layout table for location contacts
Contact: Halenur Evrendilek, MSc +902124984055 halenurevrendilek@hotmail.com

Sponsors and Collaborators
Halenur Evrendilek
Investigators
Layout table for investigator information
Principal Investigator: Halenur Evrendilek, MSc, PhD (c) Istanbul University - Cerrahpasa (IUC)
Study Director: Derya Çelik, Prof. Dr. Istanbul University - Cerrahpasa (IUC)
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Halenur Evrendilek, Research Assistant, Istanbul Kültür University
ClinicalTrials.gov Identifier: NCT06045208    
Other Study ID Numbers: 2023/52
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Halenur Evrendilek, Istanbul Kültür University:
exercise
foot posture
foot kinematic
Additional relevant MeSH terms:
Layout table for MeSH terms
Flatfoot
Talipes
Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases
 Foot Deformities, Congenital
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities