Effectiveness of Gait Retraining in Female Runners With Patellofemoral Pain

NCT ID: NCT07176819

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-21
• Study Completion Date: 2023-12-23

Brief Summary

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.

Conditions

Patellofemoral Pain, PFP

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Gait retraining

Intervention Type: 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

Intervention Type: BEHAVIORAL

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

Control group

Participants received a 6-week patient education program, which included PFP education, load management strategies, symptom-based training modifications, and strengthening exercises.

Group Type: ACTIVE_COMPARATOR

Education

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Education

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Beijing Sport University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hao-Nan Wang

Role: PRINCIPAL_INVESTIGATOR

Beijing Sport University

Locations

Beijing Sport University

Beijing, Beijing Municipality, China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

277H

Identifier Type: -

Identifier Source: org_study_id