Gait Retraining for Runners With Patellofemoral Pain

Gait Retraining Intervention for Female Runners With Patellofemoral Pain: Randomized Controlled Trial

Patellofemoral pain (PFP) is a common overuse injury in runners. Increased patellofemoral joint stress (PFJS) is an important biomechanical factor associated with PFP. Gait retraining, especially cadence modification, may reduce PFJS and improve symptoms, but evidence from randomized controlled trials remains limited. This study investigated whether wearable device-assisted gait retraining was more effective than education alone in reducing pain, improving function, and altering running biomechanics in female runners with PFP.

Study Overview

• Status: Not yet recruiting
• Conditions: Patellofemoral Pain, PFP
• Intervention / Treatment: Behavioral: Gait retraining; Behavioral: Education

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

Contacts and Locations

• Study Contact: Name: Haonan Wang; Phone Number: 8615600563019; Email: wanghaonan@bsu.edu.cn

Study Locations

• China
  • Beijing, China
    • Beijing Sport University
    • Contact: Haonan Wang; Phone Number: 8615600563019; Email: wanghaonan@bsu.edu.cn

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.	Behavioral: Gait retraining; The intervention is a wearable device-assisted gait retraining program (home) designed specifically for female runners with patellofemoral pain.; 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	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 during running	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." It will be evaluated during running.	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
Visual Analogue Scale for usual 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." It will be evaluated for usual pain.	Baseline, Week 6, Week 18
Knee Flexion Angle	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.	Baseline, Week 6
Ground Reaction Force	Ground reaction force (GRF) will be measured during overground running using embedded force plates synchronized with motion capture.	Baseline, Week 6
Visual Analogue Scale for the worst 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." It will be evaluated for the worst pain.	Baseline, Week 6, Week 18

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Step rates	Step rates refer to the number of steps taken per unit of time, usually expressed as steps per minute (steps/min).	Baseline, Week 6
Weekly running distance	Weekly running distance refers to the total distance covered by a participant through running over one week, usually expressed in kilometers (km) or meters (m). This outcome is used to assess running volume.	Baseline, Week 6

Collaborators and Investigators

• Sponsor: Beijing Sport University
• Investigators: Principal Investigator: Haonan Wang, Beijing Sport University

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: April 16, 2026
• First Submitted That Met QC Criteria: April 25, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 25, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

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

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