NCT07557797

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 29, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

May 15, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

April 16, 2026

Last Update Submit

April 25, 2026

Conditions

Keywords

Patellofemoral paingait retrainingrunner

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Visual Analogue Scale for usual pain

    Baseline, Week 6, Week 18

  • Anterior Knee Pain Scale

    Baseline, Week 6, Week 18

  • Knee Flexion Angle

    Baseline, Week 6

  • Ground Reaction Force

    Baseline, Week 6

  • Visual Analogue Scale for the worst pain

    Baseline, Week 6, Week 18

Other Outcomes (2)

  • Step rates

    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.

Behavioral: Gait retrainingBehavioral: Education

Control group

ACTIVE COMPARATOR

Participants received a 6-week patient education program

Behavioral: Education

Interventions

Gait retrainingBEHAVIORAL

The intervention is a wearable device-assisted gait retraining program (home) designed specifically for female runners with patellofemoral pain.

Gait retraining group
EducationBEHAVIORAL

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

Control groupGait retraining group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Sport University

Beijing, China

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Haonan Wang

    Beijing Sport University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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
PRINCIPAL INVESTIGATOR
PI Title
Research Fellow

Study Record Dates

First Submitted

April 16, 2026

First Posted

April 29, 2026

Study Start (Estimated)

May 15, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 15, 2026

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

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