Investigation of Kinesiophobia and Functional Status of Patients After MPFL Reconstruction

Kinesiophobia Clinical Trial

Official title:

Investigation of Kinesiophobia and Functional Status of Patients After MPFL Reconstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06009822
• Other study ID #: Iayas4
• Status: Recruiting
• Start date: August 1, 2023
• Est. completion date: October 2023

Study information

• Verified date: August 2023
• Source: Gazi University
• Contact: Inci H Ayas, Msc
• Phone: +90 0312 216 26 01
• Email: inciayass[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 2023
• Est. primary completion date: September 30, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kinesiophobia

Intervention

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.

Locations

Country	Name	City	State
Turkey	Gazi University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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