Effectiveness of Gait Retraining in Female Runners With Patellofemoral Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Patellofemoral Pain, PFP
• Intervention / Treatment: Behavioral: Gait retraining; Behavioral: Education

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100084
      • Beijing Sport University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gait retraining group; Participants received a 6-week gait retraining program plus patient education. The gait retraining program primarily consisted of increasing the step rate by 10%, monitored via a smartwatch.	Behavioral: Gait retraining; 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.; Behavioral: Education; PFP education, load management strategies, symptom-based training modifications, and strengthening exercises.
Active Comparator: Control group; Participants received a 6-week patient education program, which included PFP education, load management strategies, symptom-based training modifications, and strengthening exercises.	Behavioral: Education; PFP education, load management strategies, symptom-based training modifications, and strengthening exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale for Pain	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."	Baseline, Week 6, Week 18

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anterior Knee Pain Scale	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.	Baseline, Week 6, Week 18
Peak Knee Flexion Angle During Running	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.	Baseline, Week 6
Ground Reaction Force During Running	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.	Baseline, Week 6
Running Cadence	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	Baseline, Week 6
Weekly running distance	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.	Baseline, Week 6

Collaborators and Investigators

• Sponsor: Beijing Sport University
• Investigators: Principal Investigator: Hao-Nan Wang, Beijing Sport University

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2023
• Primary Completion (Actual): December 23, 2023
• Study Completion (Actual): December 23, 2023

Study Registration Dates

• First Submitted: September 6, 2025
• First Submitted That Met QC Criteria: September 12, 2025
• First Posted (Estimated): September 16, 2025

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 12, 2025
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Patellofemoral pain; gait retraining
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Patellofemoral Pain Syndrome; Socioeconomic Factors; Population Characteristics; Educational Status
• Other Study ID Numbers: 277H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

- What IPD will be shared: De-identified individual participant data that underlie the results reported in the publication, including baseline characteristics, outcome measures (pain scores, functional scores, running mechanics), and adverse events.

- When will IPD be available: Beginning 6 months after publication of the main trial results, for up to 5 years.

- With whom: Researchers who provide a methodologically sound proposal to achieve aims consistent with the original study.

- For what types of analyses: For individual participant data meta-analyses and reproducibility purposes.

- How to access data: Proposals should be directed to the corresponding author (wanghaonan@bsu.edu.cn). Data access will be provided via secure data transfer after approval of a data-sharing agreement.

• IPD Sharing Time Frame: Beginning 6 months after publication of the main trial results, for up to 5 years.

IPD Sharing Access Criteria

- With whom: Researchers who provide a methodologically sound proposal to achieve aims consistent with the original study.

- For what types of analyses: For individual participant data meta-analyses and reproducibility purposes.

- How to access data: Proposals should be directed to the corresponding author (wanghaonan@bsu.edu.cn). Data access will be provided via secure data transfer after approval of a data-sharing agreement.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

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