Skip to main content
OpenTrials
Completed

NCT Number: NCT07176819

Effectiveness of Gait Retraining in Female Runners With Patellofemoral Pain

Patellofemoral pain (PFP) is the most common running-related overuse injury, with prevalence up to 17% among runners. Increased patellofemoral joint stress (PFJS) is a major biomechanical contributor to PFP. Traditional strengthening exercises improve function but do not alter running biomechanics. Gait retraining, particularly cadence modification, has been proposed as a promising approach to reduce PFJS and alleviate symptoms. However, evidence from randomized controlled trials remains limited. This study investigates whether wearable device-assisted gait retraining reduces pain, improves function, and modifies running biomechanics in female runners with PFP compared to education alone.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Patellofemoral Pain, PFP Joint Diseases Musculoskeletal Diseases Patellofemoral Pain Syndrome

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Sport University

Beijing, Beijing Municipality, 100084, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female, Age 18-45 years
  • Unilateral/bilateral anterior knee pain > 4 weeks
  • VAS pain ≥ 3/10 during running and ≥ 2 of the following: jumping, squatting, kneeling, stairs, prolonged sitting, or resisted knee extension
  • Running ≥ 15 km per week
  • Natural rearfoot striker

Exclusion criteria

  • Acute trauma, history of patellar dislocation, meniscal/chondral lesions
  • Prior knee surgery or injection in past 12 months
  • Rheumatologic, neurologic, or degenerative disease
  • Pregnancy

Treatment and study plan

Gait Retraining

Behavioral

The intervention is a wearable device-assisted gait retraining program designed specifically for female runners with patellofemoral pain (PFP). Unlike conventional physiotherapy or exercise-based interventions, this program integrates real-time biofeedback through a commercially available smartwatch and its mobile application. Participants are instructed to increase their step rate by 10% above their preferred cadence. The smartwatch provides auditory metronome cues and real-time cadence feedback to ensure accurate step-rate modification.

Education

Behavioral

PFP education, load management strategies, symptom-based training modifications, and strengthening exercises.

Primary outcomes

  1. Visual Analogue Scale for Pain

    Time frame: Baseline, Week 6, Week 18

    The Visual Analogue Scale (VAS) is a validated, widely used instrument for assessing subjective pain intensity. It consists of a 10-centimeter horizontal line, with one end (0) representing "no pain" and the other end (10) representing "worst imaginable pain."

Secondary outcomes

  1. Anterior Knee Pain Scale

    Time frame: Baseline, Week 6, Week 18

    The Anterior Knee Pain Scale (AKPS), also referred to as the Kujala Score, is a patient-reported outcome measure designed to evaluate symptoms and functional limitations associated with anterior knee pain and patellofemoral disorders. It consists of 13 items covering domains such as pain during various activities (e.g., walking, running, jumping, climbing stairs, squatting), functional limitations, abnormal gait, muscle atrophy, and difficulty with prolonged sitting. Each item is scored on an ordinal scale, and the total score ranges from 0 to 100, with higher scores indicating better knee function and fewer symptoms.

  2. Peak Knee Flexion Angle During Running

    Time frame: Baseline, Week 6

    Peak knee flexion angle will be assessed during running trials using a 3-dimensional motion capture system. Reflective markers will be placed according to a standard lower-limb biomechanical model. The angle is defined as the maximum knee flexion angle observed during stance phase of running.

  3. Ground Reaction Force During Running

    Time frame: Baseline, Week 6

    Ground reaction force (GRF) will be measured during overground running using embedded force plates synchronized with motion capture. The variable of interest is the peak force normalized to body weight.

  4. Running Cadence

    Time frame: Baseline, Week 6

    Running cadence will be assessed as the number of steps taken per minute during running. Measurement will be conducted using a wearable device running sessions

  5. Weekly running distance

    Time frame: Baseline, Week 6

    Weekly running distance will be recorded as the total distance covered in running sessions over a 7-day period. Data will be collected from participants' GPS-based tracking devices.

Sponsors and collaborators

Lead sponsor

Beijing Sport University

Other

Registry information

Official study title

Effectiveness of Gait Retraining in Female Runners With Patellofemoral Pain: A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 16, 2025
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.