Foot and Lower Extremity Exercises in Adolescents With Pes Planovalgus

• ClinicalTrials.gov Identifier: NCT06045208
• Recruitment Status: Not yet recruiting
• First Posted: September 21, 2023
• Last Update Posted: September 21, 2023
• Sponsor: Halenur Evrendilek
• Information provided by (Responsible Party): Halenur Evrendilek, Istanbul Kültür University

Tracking Information

• First Submitted Date: September 13, 2023
• First Posted Date: September 21, 2023
• Last Update Posted Date: September 21, 2023
• Estimated Study Start Date: October 2023
• Estimated Primary Completion Date: October 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 13, 2023)

• 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.
• 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.
• 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.
• 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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: September 13, 2023)

• 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.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Flat Foot

Intervention

• Other: Foot exercise
  This group will engage in an 8-week foot intrinsic strengthening training
• Other: Lower Extremity Exercise
  This group will engage in an 8-week lower extremity strengthening training

Study Arms

• Active Comparator: Foot Exercise Group (FEG)
  Intervention: Other: Foot exercise
• Active Comparator: Lower Extremity Exercise Group (LEEG)
  Intervention: Other: Lower Extremity Exercise
• No Intervention: Control Group (CG)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: September 13, 2023): 45
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2024
• Estimated Primary Completion Date: October 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Halenur Evrendilek, MSc; +902124984055; halenurevrendilek@hotmail.com

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT06045208
• Other Study ID Numbers: 2023/52
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Halenur Evrendilek, Istanbul Kültür University
• Original Responsible Party: Same as current
• Current Study Sponsor: Halenur Evrendilek
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Istanbul Kültür University
• Verification Date: September 2023