NCT06752109

Brief Summary

This study aims to investigate the biomechanical mechanisms of dynamic knee valgus and the impact of subtalar pronation, particularly due to decreased medial longitudinal arch, on knee injury risk, highlighting the importance of prevention and intervention strategies for athlete health.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 30, 2024

Completed
Last Updated

January 30, 2025

Status Verified

December 1, 2024

Enrollment Period

3 months

First QC Date

December 17, 2024

Last Update Submit

January 28, 2025

Conditions

Keywords

Pes planusACLDynamic Tape

Outcome Measures

Primary Outcomes (3)

  • Single Leg Squat Test

    In this test, athletes were instructed to perform a single-leg squat with their hands on their waist, maintaining balance for as long as possible, preferably for 5 seconds. Only trials that reached the required minimum flexion angle and maintained balance were considered valid. Three valid attempts were performed. During the tests, video recordings were made from both the front and the side. The footage was analyzed using the Microsoft OptoJump® Next program with a 2D analysis method to measure knee flexion and valgus angles.

    Pre-taping and within 1 hour after taping

  • Single Leg Landing Test

    For this test, each athlete was asked to step off a 30 cm high box and extend the measurement leg forward to drop downward. The maximum knee valgus and flexion angles at the end of the drop were measured using two camera recordings, one from the front and one from the side. During the tests, video recordings were made from both the front and the side. The footage was analyzed using the Microsoft OptoJump® Next program with a 2D analysis method to measure knee flexion and valgus angles.

    Pre-taping and within 1 hour after taping

  • Vertical Drop Jump Test

    In this test, athletes were instructed to stand with their feet shoulder-width apart on a 30 cm high box. They were then asked to jump into the square area in front of the box and immediately jump as far as possible using their arms for assistance. The test was completed once the athlete had made three successful jumps. The average of the three jumps was recorded. During the tests, video recordings were made from both the front and the side. The footage was analyzed using the Microsoft OptoJump® Next program with a 2D analysis method to measure knee flexion and valgus angles.

    Pre-taping and within 1 hour after taping

Study Arms (2)

Intervention

EXPERIMENTAL

Dynamic Tape

Other: Antipronation Taping

Control

SHAM COMPARATOR

Sham Group

Other: Sham

Interventions

Before applying the tape, its length was measured by passing it over the areas on the foot where it would be applied. The tape was first attached to the medial side of the big toe, with tension in the direction of flexion and abduction of the toe. The ankle was then positioned in full plantar flexion. The tape was applied from the medial side of the foot towards the heel, wrapping around it, and then directed towards the sole. While the foot was in an inversion position at the navicular level, the tape was applied with maximum tension from medial to lateral and brought back to the sole. The remainder of the tape, with maximum tension, was applied from the sole to the dorsal side of the ankle, ending without tension at the proximal and lateral side of the leg. A second strip of tape, with maximum tension, was applied to support the medial longitudinal arch. The ends of the tape were placed over the malleoli without tension, aiming to reduce excessive pronation.

Intervention
ShamOTHER

In the sham taping application, the length of the tape was measured by passing it over the areas where it would be applied. The tape was applied to the medial side of the big toe, but without tension, simply placed. Then, the tape was directed towards the sole of the foot, passing over the heel. At the navicular level, the tape was applied from medial to lateral, returning to the sole without tension. A second strip of tape was applied to the sole without tension. The ends of the tape were placed over the malleoli without stretching. Since no tension was applied, this application was only placed and has a limited effect on reducing excessive pronation.

Control

Eligibility Criteria

Age16 Years - 25 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Actively playing volleyball for at least 5 years, A drop of 10 mm or more in the navicular drop test, A score of ≥ +4 according to the A foot posture index.

You may not qualify if:

  • A history of lower extremity injury within the last 3 months, A history of ankle and/or knee surgery, Having non-structural instability, A history of congenital or traumatic deformity in the lower extremity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, 06000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament InjuriesFlatfoot

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and InjuriesTalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Msc

Study Record Dates

First Submitted

December 17, 2024

First Posted

December 30, 2024

Study Start

August 10, 2021

Primary Completion

November 1, 2021

Study Completion

February 1, 2022

Last Updated

January 30, 2025

Record last verified: 2024-12

Locations