Effectiveness of Gait Retraining in Female Runners With Patellofemoral Pain

NCT07176819 | Completed DMC

• 1 other identifier: 277H
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Keywords

Patellofemoral pain; gait retraining

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Anterior Knee Pain Scale

  Baseline, Week 6, Week 18

• Peak Knee Flexion Angle During Running

  Baseline, Week 6

• Ground Reaction Force During Running

  Baseline, Week 6

• Running Cadence

  Baseline, Week 6

• Weekly running distance

  Baseline, Week 6

Study Arms (2)

Gait retraining group

EXPERIMENTAL

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; Behavioral: Education

Control group

ACTIVE COMPARATOR

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

Behavioral: Education

Interventions

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.

Gait retraining group

Education BEHAVIORAL

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

Control group; Gait retraining group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Sport University: lead

Study Sites (1)

Beijing Sport University

Beijing, Beijing Municipality, 100084, China

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Hao-Nan Wang

  Beijing Sport University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2025
• First Posted: September 16, 2025
• Study Start: February 21, 2023
• Primary Completion: December 23, 2023
• Study Completion: December 23, 2023
• Last Updated: September 16, 2025

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months after publication of the main trial results, for up to 5 years.
• 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.

Locations

CN (1)