Patellofemoral Pain, PFPNCT07176819
Effectiveness of Gait Retraining in Female Runners With Patellofemoral Pain
A study testing Gait retraining and Education in people with Patellofemoral Pain, PFP, run by Beijing Sport University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Patellofemoral Pain, PFP
- What is being tested?
- Gait retraining and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 21 Feb 2023to 23 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Acute trauma, history of patellar dislocation, meniscal/chondral lesions
- Prior knee surgery or injection in past 12 months
- Rheumatologic, neurologic, or degenerative disease
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Gait Retraining in Female Runners With Patellofemoral Pain: A Randomized Controlled Trial
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
- Being tested
- Gait retraining, Education
- Keywords
- Patellofemoral pain, gait retraining
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait retrainingBehavioural
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.
EducationBehavioural
PFP education, load management strategies, symptom-based training modifications, and strengthening exercises.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: Baseline, Week 6, Week 18
Secondary outcomes (5)
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.
Measured: Baseline, Week 6, Week 18
Peak Knee Flexion Angle During Running
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. The angle is defined as the maximum knee flexion angle observed during stance phase of running.
Measured: Baseline, Week 6
Ground Reaction Force During Running
Ground reaction force (GRF) will be measured during overground running using embedded force plates synchronized with motion capture. The variable of interest is the peak force normalized to body weight.
Measured: Baseline, Week 6
Running Cadence
Running cadence will be assessed as the number of steps taken per minute during running. Measurement will be conducted using a wearable device running sessions
Measured: Baseline, Week 6
Weekly running distance
Weekly running distance will be recorded as the total distance covered in running sessions over a 7-day period. Data will be collected from participants' GPS-based tracking devices.
Measured: Baseline, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start21 Feb 2023
- Primary completion23 Dec 2023
- Study completion23 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral Pain, PFPStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Sport University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hao-Nan Wang, Principal investigator, Beijing Sport University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07176819
- Sponsor's protocol ID
- 277H
- Status last verified
- Mar 2023
- First submitted
- 6 Sep 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: \- 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Gait Retraining in Female Runners With Patellofemoral Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07176819
- Acronym / sponsor ID
- 277H
- Conditions
- Patellofemoral Pain, PFP
- Keywords
- Patellofemoral pain, gait retraining
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Beijing Sport UniversityUniversity, hospital or other
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 23 Dec 2023 (actual)
- Study completion
- 23 Dec 2023 (actual)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gait retraining group | Experimental | Behavioral: Gait retraining, Behavioral: EducationParticipants 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. |
| Control group | Active comparator | Behavioral: EducationParticipants received a 6-week patient education program, which included PFP education, load management strategies, symptom-based training modifications, and strengthening exercises. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Acute trauma, history of patellar dislocation, meniscal/chondral lesions
- Prior knee surgery or injection in past 12 months
- Rheumatologic, neurologic, or degenerative disease
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait retrainingThe 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. | Behavioural | Gait retraining group |
| EducationPFP education, load management strategies, symptom-based training modifications, and strengthening exercises. | Behavioural | Control group, Gait retraining group |
Primary outcome
Visual Analogue Scale for 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."
5 secondary outcomes
Anterior Knee Pain Scale
Time frame: Baseline, Week 6, Week 18
Peak Knee Flexion Angle During Running
Time frame: Baseline, Week 6
Ground Reaction Force During Running
Time frame: Baseline, Week 6
Running Cadence
Time frame: Baseline, Week 6
Weekly running distance
Time frame: Baseline, Week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: Yes. - 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.
Related trials for Patellofemoral Pain, PFP
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Stabilization vs Corrective Exercise in PFP
Patellofemoral Pain Syndrome
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The Effect of a Treatment Protocol Focused on Neuromuscular Control Exercises on Pain and Function in a Subgroup of Individuals With Patellofemoral Pain
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Gait Retraining for Runners With Patellofemoral Pain
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Telerehabilitation for Patellofemoral Pain
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Comparison Between Foot Segment Mulligan Mobilization and Ilium Mulligan Mobilization in Treatment Patellofemoral Pain Patients With Flatfeet: a Randomized Controlled Comparative Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hao-Nan Wang principal investigator
Beijing Sport University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait retraining and Education in people with Patellofemoral Pain, PFP, run by Beijing Sport University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale for Pain (time frame: Baseline, Week 6, Week 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.