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Foot and Lower Extremity Exercises in Adolescents With Pes Planovalgus

Primary Purpose

Flat Foot

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Foot exercise
Lower Extremity Exercise
Sponsored by
Halenur Evrendilek
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Flat Foot focused on measuring exercise, foot posture, foot kinematic

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    No Intervention

    Arm Label

    Foot Exercise Group (FEG)

    Lower Extremity Exercise Group (LEEG)

    Control Group (CG)

    Arm Description

    Outcomes

    Primary Outcome Measures

    Foot posture assesment
    Foot Posture Index 6 and navicular drop will be used for assesing the foot pronation.
    Foot muscle strentgh assesment
    Toe muscle strength will be assessed through the utilization of a handheld dynamometer.
    Performance and dynamic balance assesment
    Front jump test and star excursion balance test will be performed by participants.
    3D gait analysis
    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

    Functional assesment
    The Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) will be utilized for function-related aspect.
    Quality of life assesment
    Pediatric Quality of Life Inventory (PedsQL) will be utilized for the assessment of participants' quality of life status.

    Full Information

    First Posted
    September 13, 2023
    Last Updated
    September 13, 2023
    Sponsor
    Halenur Evrendilek
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06045208
    Brief Title
    Foot and Lower Extremity Exercises in Adolescents With Pes Planovalgus
    Official Title
    Comparison of the Effects of Foot and Lower Extremity Strengthening Exercises in Adolescents With Pes Planovalgus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    October 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Halenur Evrendilek

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Flat Foot
    Keywords
    exercise, foot posture, foot kinematic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    45 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Foot Exercise Group (FEG)
    Arm Type
    Active Comparator
    Arm Title
    Lower Extremity Exercise Group (LEEG)
    Arm Type
    Active Comparator
    Arm Title
    Control Group (CG)
    Arm Type
    No Intervention
    Intervention Type
    Other
    Intervention Name(s)
    Foot exercise
    Intervention Description
    This group will engage in an 8-week foot intrinsic strengthening training
    Intervention Type
    Other
    Intervention Name(s)
    Lower Extremity Exercise
    Intervention Description
    This group will engage in an 8-week lower extremity strengthening training
    Primary Outcome Measure Information:
    Title
    Foot posture assesment
    Description
    Foot Posture Index 6 and navicular drop will be used for assesing the foot pronation.
    Time Frame
    Pre-intervention assesment and after 8-week
    Title
    Foot muscle strentgh assesment
    Description
    Toe muscle strength will be assessed through the utilization of a handheld dynamometer.
    Time Frame
    Pre-intervention assesment and after 8-week
    Title
    Performance and dynamic balance assesment
    Description
    Front jump test and star excursion balance test will be performed by participants.
    Time Frame
    Pre-intervention assesment and after 8-week
    Title
    3D gait analysis
    Description
    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.
    Time Frame
    Pre-intervention assesment and after 8-week
    Secondary Outcome Measure Information:
    Title
    Functional assesment
    Description
    The Oxford Ankle Foot Questionnaire for Children (OxAFQ-C) will be utilized for function-related aspect.
    Time Frame
    Pre-intervention assesment and after 8-week
    Title
    Quality of life assesment
    Description
    Pediatric Quality of Life Inventory (PedsQL) will be utilized for the assessment of participants' quality of life status.
    Time Frame
    Pre-intervention assesment and after 8-week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Halenur Evrendilek, MSc
    Phone
    +902124984055
    Email
    halenurevrendilek@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Halenur Evrendilek, MSc, PhD (c)
    Organizational Affiliation
    Istanbul University - Cerrahpasa (IUC)
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Derya Çelik, Prof. Dr.
    Organizational Affiliation
    Istanbul University - Cerrahpasa (IUC)
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Foot and Lower Extremity Exercises in Adolescents With Pes Planovalgus

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