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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gait retraining group | Experimental | Participants received a 6-week gait retraining program plus patient education. |
|
| Control group | Active Comparator | Participants received a 6-week patient education program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gait retraining | Behavioral | The intervention is a wearable device-assisted gait retraining program (home) designed specifically for female runners with patellofemoral pain. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale for usual 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." It will be evaluated for usual pain. | Baseline, Week 6, Week 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Step rates | Step rates refer to the number of steps taken per unit of time, usually expressed as steps per minute (steps/min). | Baseline, Week 6 |
| Weekly running distance | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haonan Wang | Contact | 8615600563019 | wanghaonan@bsu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Haonan Wang | Beijing Sport University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Sport University | Beijing | China |
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.
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 1, 2026 | Apr 1, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D046788 | Patellofemoral Pain Syndrome |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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| Education | Behavioral | PFP education, load management strategies, symptom-based training modifications, and strengthening exercises |
|
| 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. | Baseline, Week 6, Week 18 |
| Knee Flexion Angle | 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. | Baseline, Week 6 |
| Ground Reaction Force | Ground reaction force (GRF) will be measured during overground running using embedded force plates synchronized with motion capture. | Baseline, Week 6 |
| Visual Analogue Scale for the worst 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." It will be evaluated for the worst pain. | Baseline, Week 6, Week 18 |
| Baseline, Week 6 |