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NCT Number: NCT07557797

Gait Retraining for Runners With Patellofemoral Pain

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.

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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

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 (home) designed specifically for female runners with patellofemoral pain.

Education

Behavioral

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

Primary outcomes

  1. Visual Analogue Scale for Pain during running

    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." It will be evaluated during running.

Secondary outcomes

  1. Visual Analogue Scale for usual 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." It will be evaluated for usual pain.

  2. 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.

  3. Knee Flexion Angle

    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.

  4. Ground Reaction Force

    Time frame: Baseline, Week 6

    Ground reaction force (GRF) will be measured during overground running using embedded force plates synchronized with motion capture.

  5. Visual Analogue Scale for the worst 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." It will be evaluated for the worst pain.

Other outcomes

  1. Step rates

    Time frame: Baseline, Week 6

    Step rates refer to the number of steps taken per unit of time, usually expressed as steps per minute (steps/min).

  2. Weekly running distance

    Time frame: Baseline, Week 6

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Haonan Wang

CONTACT

[email protected]

8615600563019

Sponsors and collaborators

Lead sponsor

Beijing Sport University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 29, 2026
Registry last updated
Apr 29, 2026

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.

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