Investigation of Kinesiophobia and Functional Status of Patients After MPFL Reconstruction

Our aim in this study is to examine the functional and clinical results of patients who have undergone MPFL reconstruction at least 2 years after the operation. The presence of kinesiophobia of the patients will be evaluated and its relationship with functional outcomes will be examined.

Study Overview

• Status: Recruiting
• Conditions: Kinesiophobia; Medial Patellofemoral Dislocation
• Intervention / Treatment: Other: Postoperative outcome measurements

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: İnci H Ayas, Msc; Phone Number: +90 0312 216 26 01; Email: inciayass@gmail.com
• Study Contact Backup: Name: Zeynep Hazar, PhD; Phone Number: +90 0312 216 26 01; Email: zhazar@gazi.edu.tr

Study Locations

• Turkey
  • Ankara, Turkey
    • Recruiting
    • Gazi University
    • Contact: Zeynep Hazar, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent unilateral MPFL reconstruction in the Department of Orthopedics and Traumatology, Gazi University Hospital between 2004 and 2019

Description

Inclusion Criteria:

• Undergone unilateral medial patellofemoral ligament (MPFL) reconstruction
• At least 2 years after the operation

Exclusion Criteria:

• Patellar instability
• Knee ligament injury
• Meniscus injury
• Knee osteoarthritis
• Ankle ligament injury
• Ankle osteoarthritis
• Any neurological disease

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients with Medial Patellofemoral Ligament reconstruction; Must have undergone unilateral medial patellofemoral ligament (MPFL) reconstruction. At least 2 years post MPFL reconstruction surgery. Absence of patellar instability subsequent to the surgical procedure. Exclusion of patients with any orthopedic or neurological issues that might impact functionality, except for those who have undergone unilateral MPFL reconstruction.

Other: Postoperative outcome measurements; Kinesiophobia; It will be assessed on the Tampa Kinesiophobia Scale. Function; Lysholm knee score, kujala knee score, single-leg hop test, Y balance test and single leg sway index will be evaluated. Biodex Bio-balance system device will be used for single leg sway index.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kinesiophobia	Kinesiophobia refers to an excessive, irrational fear of movement or physical activity. The Tampa Scale for Kinesiophobia was used for assessment. The Tampa Scale for Kinesiophobia is scored between 17-68. A high score indicates high kinesiophobia.	up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Score	Function will be measured by the Lysholm knee score.The total score on the Lysholm Knee Score questionnaire can range from 0 to 100, with higher scores indicating better knee function and less impairment. General breakdown of the score interpretation: 95-100: Excellent knee function 84-94: Good knee function 65-83: Fair knee function Below 65: Poor knee function	up to 3 months
Patellofemoral Knee Score	Function will be measured by the Kujala Patellofemoral Knee Score. The total score on the Kujala Patellofemoral Knee Score questionnaire can range from 0 to 100, with higher scores indicating better knee function and less impairment. General breakdown of the score interpretation: 100: No limitations or symptoms 85-99: Mild limitations or symptoms 70-84: Moderate limitations or symptoms Below 70: Severe limitations or symptoms	up to 3 months
Single-leg hop test	The single-leg hop distance is an indicator of lower extremity function. The test evaluates an individual's lower limb strength, power, and overall functional performance. It specifically focuses on assessing an individual's ability to generate power and stability while performing a single-leg hop for maximal distance. When performing the test, the individual starts by standing on one leg at the starting point. The opposite leg is lifted slightly off the ground, and the hands can be placed on the hips or kept at the sides for balance. On the command to start, the individual hops forward on the single leg, aiming to jump as far as possible while maintaining control and balance. Perform 3 repetitions and record the longest distance jumped.	up to 3 months
Dynamic balance	Dynamic balance will be measured by Y Balance Test. The Y Balance Test involves a person standing on one leg while reaching in anterior (forward), posteromedial (backward and to the side), and posterolateral (backward and to the other side) directions with the other leg. The person places their stance foot at the starting point on the central part of the Y-shaped device.While maintaining balance on the stance leg, the person reaches the free leg as far as possible along each of the three arms of the Y.The distance reached in each direction is measured and recorded.	up to 3 months
Static balance	Static balance will be measured using a Biodex Balance System, single leg sway index test procedure. The device reports the person's body oscillations as sway index. A high stability index indicates poor postural control.	up to 3 months

Collaborators and Investigators

• Sponsor: Gazi University
• Investigators: Study Director: Zeynep Hazar, Gazi University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): September 30, 2023
• Study Completion (Estimated): October 1, 2023

Study Registration Dates

• First Submitted: August 8, 2023
• First Submitted That Met QC Criteria: August 22, 2023
• First Posted (Actual): August 24, 2023

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 22, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Phobic Disorders; Kinesiophobia
• Other Study ID Numbers: Iayas4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No