NCT07068984

Brief Summary

Background: Patellofemoral pain syndrome (PFPS) is a common functional disorder of knee joint. Its etiology involves biomechanical abnormalities and dynamic stability defects. Most of the existing studies focus on young people, and the biomechanical characteristics and functional compensation mechanism of middle-aged and elderly patients are still unclear. The Y-Balance test is becoming an important tool in PFPS research because of its sensitivity to assess the dynamic balance ability of lower limbs. Objective: To analyze the functional characteristics of lower limbs of PFPS patients aged 40-60 by Y-Balance test, and to explore the differences between PFPS patients and healthy people, so as to provide evidence for clinical rehabilitation. Methods: A cross-sectional observational study was conducted in 49 PFPS patients and 21 healthy controls. Y-Balance test was used to evaluate bilateral forward difference, composite score, lateral and posterior balance, symmetry ratio and bilateral difference. SPSS 25.0 was used for statistical analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 16, 2025

Completed
Last Updated

July 16, 2025

Status Verified

April 1, 2025

Enrollment Period

1 month

First QC Date

May 28, 2025

Last Update Submit

July 7, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Analysis of Y-balance characteristics of patellofemoral pain syndrome

    Outcome Measure Title:Y-Balance Test (YBT) Reach Distance (cm) - Comparison between Patellofemoral Pain Syndrome (PFPS) Patients (Aged 40-60 Years) and Healthy Controls Outcome Measure Description:The Y-Balance Test (YBT) was used to assess dynamic balance function of the lower limbs in participants. Metrics Measured: The maximum reach distance (in centimeters, cm) achieved by participants in three directions (Anterior, Posteromedial, Posterolateral) during single-leg stance. Data Summary:The average maximum reach distance (cm) from three valid trials was calculated for each direction, separately for the left and right legs. Comparative Analysis: The average maximum reach distance (cm) in each direction for the left and right legs in the PFPS patient group (aged 40-60 years) were compared with the corresponding metrics in an age- and sex-matched group of healthy controls to analyze between-group differences.

    Baseline

Study Arms (2)

Twenty-one healthy controls were enrolled

2

Other: Differences between lower limb balances were assessed by the Y-Balance test

A total of 49 patients with PFPS and 21 healthy controls were enrolled

Interventions

The Y-Balance test was used to evaluate bilateral anterior difference, composite score, lateral and posterior balance, symmetry ratio and bilateral difference

Twenty-one healthy controls were enrolled

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

People with patellar pain

You may qualify if:

  • Aged between 40 and 60 years
  • Clinically diagnosed with patellofemoral pain (PFP) with symptoms lasting ≥3 months
  • No other serious lower extremity disorders
  • No neurological diseases
  • No history of recent lower extremity surgery (\<12 months)
  • No history of major lower extremity trauma
  • Control group: Age- and sex-matched healthy volunteers without knee pain or lower limb dysfunction

You may not qualify if:

  • Acute inflammatory conditions Meniscus injury Knee ligament injury Intra-articular fracture Bone tumor Bone tuberculosis
  • Neurovascular injury including:
  • Stroke history
  • Parkinson's disease Subjective unwillingness to comply with testing Inability to complete Y-Balance Test
  • Serious systemic diseases affecting:
  • Cardiovascular system Hepatic function Renal function Hematological system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing

Beijing, Beijing Municipality, 100191, China

Location

Related Publications (1)

  • Zheng Z, Fan H, Hongjie H, Jianquan W. Deficits in dynamic stability revealed by the Y-Balance test in middle-aged and elderly adults with patellofemoral pain. J Orthop Surg Res. 2026 Jan 28. doi: 10.1186/s13018-026-06684-9. Online ahead of print.

Biospecimen

Retention: SAMPLES WITHOUT DNA

A total of 49 patients with PFPS and 21 healthy controls were enrolled

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2025

First Posted

July 16, 2025

Study Start

March 1, 2025

Primary Completion

April 1, 2025

Study Completion

April 10, 2025

Last Updated

July 16, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

Locations