NCT06776562

Brief Summary

Dynamic knee valgus (DKV) is a movement pattern of the lower limb potentially consisting of a combination of adduction and internal rotation of the femur, knee abduction, tibial anterior translation, tibial external rotation and ankle eversion. Average "normal" performance during a fall jump landing mission knee valgus angle should be in the range of 7-13 degrees in women and 3-8 degrees in men. This faulty movement pattern is a common dysfunction observed in the lower limb during dynamic activities. On the other hand, this is reported to be the underlying mechanism of knee injuries. Changes in knee valgus increase abnormal stresses on the tibiofemoral joint and increase the risk of injuries such as anterior cruciate ligament injuries, patellofemoral pain, iliotibial band syndrome, chronic ankle instability, acute lateral ankle sprains. The main cause of DKV is deficits in neuromuscular control and therefore injury prevention and rehabilitation strategies focus on improving neuromuscular control to avoid these injury mechanisms. There are conflicting results in the literature regarding which of the exercise approaches is superior for DKV, and there is a lack of studies evaluating 2D movement analysis, muscle mechanics and performance of corrective exercise training. Identifying individuals with abnormal movement patterns and those at risk is important to prevent future injuries. The aim of the study was to investigate the effect of corrective exercises on lower extremity biomechanics and performance in individuals with asymptomatic dynamic knee valgus.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

October 11, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 15, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2025

Completed
Last Updated

January 15, 2025

Status Verified

January 1, 2025

Enrollment Period

5 months

First QC Date

January 7, 2025

Last Update Submit

January 14, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Frontal plan projection angle evaluation

    It will be evaluated with the Single Leg Drop Jump test. Kinovea® 2D motion two-dimensional video analysis software will be used to measure the knee-valgus/varus anterior plane projection angle (FPPA).

    Before the intervention, up to 8 weeks

  • Single leg squat test

    During the test, they will be asked to perform a single-leg squat from a static position to at least 60° knee flexion and then return to the starting position. Kinovea® 2D motion two-dimensional video analysis software will be used for the measurement.

    Before the intervention, up to 8 weeks

  • Viscoelastic properties of muscle

    The viscoelastic properties of the participants' muscle will be measured using a myotonometer (MyotonPRO, Tallinn, Estonia). It will be performed on the quadriceps, hamstring, gastrocnemius and hip adductor muscles. Individuals will be asked to contract the muscle and the center of the muscle mass will be identified and marked. The muscle will then be asked to relax. For the measurement, the probe is placed over the muscle, perpendicular to the skin surface, and mechanical force is applied to the subcutaneous tissue for a constant 15 milliseconds. The interval between each pulse is 8 ms and 5 pulses.

    Before the intervention, up to 8 weeks

Secondary Outcomes (5)

  • Static Balance Measurement

    Before the intervention, up to 8 weeks

  • Dynamic Balance Measurement

    Before the intervention, up to 8 weeks

  • Single Leg Forward Jump Test

    Before the intervention, up to 8 weeks

  • Three Step Forward Jump Test

    Before the intervention, up to 8 weeks

  • Vertical Jump Test

    Before the intervention, up to 8 weeks

Study Arms (2)

Exercise group

EXPERIMENTAL

Intervention includes corrective exercises for dynamic knee valgus

Other: Exercise

Control group

ACTIVE COMPARATOR

The control group will be followed without intervention.

Other: Control

Interventions

Education on activities of daily living will be provided. In addition, a program including muscle strengthening, neuromuscular control and flexibility exercises for lower extremity and trunk muscles will be performed. Exercise Program will be performed for 8 weeks, 2 sessions per week.

Exercise group
ControlOTHER

Education will be provided for activities of daily living. Individuals with dynamic knee valgus in the control group will not receive any intervention. Exercise program will be implemented after the end of the study.

Control group

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between 18 and 25 years of age
  • Have asymptomatic dynamic knee valgus
  • Being woman

You may not qualify if:

  • BMI≥ 30 kg/cm2
  • Lower extremity musculoskeletal pain
  • Lower extremity injury in the past 1 year
  • History of lower limb surgery
  • Neurological condition that may affect balance and coordination during the test
  • More than half an hour of intense exercise per week
  • Those who exercise vigorously for more than half an hour per week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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
Lecturer

Study Record Dates

First Submitted

January 7, 2025

First Posted

January 15, 2025

Study Start

October 11, 2024

Primary Completion

March 22, 2025

Study Completion

June 15, 2025

Last Updated

January 15, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations