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This randomized controlled superiority trial will compare a 6-week digital health rehabilitation program with a 6-week self-guided exercise program in adults with patellofemoral pain. Assessments will be performed at baseline, 6 weeks, and 18 weeks. The primary outcome will be change in AKPS from baseline to 6 weeks. Secondary outcomes will include pain intensity, self-reported function, psychological outcomes, quality of life, muscle strength, adherence, and adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital health group | Experimental |
| |
| Control group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital health | Behavioral | Participants will receive a 6-week digital health program delivered through a smartphone application mini-program. The intervention will include:
|
| Measure | Description | Time Frame |
|---|---|---|
| Anterior Knee Pain Scale | Baseline; 6 weeks; 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Knee injury and Osteoarthritis Outcome Score | Baseline; 6 weeks; 18 weeks | |
| Tampa Scale for Kinesiophobia | Baseline; 6 weeks; 18 weeks | |
| Pain Catastrophizing Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei-Yang Zhang | Contact | 8615196279571 | weiyangz@cdsu.edu.cn |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 9, 2025 | Apr 16, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000097103 | Digital Health |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| Self-guided exercise | Behavioral | Participants will receive a 6-week self-guided home exercise program with initial instruction delivered in printed format. Participants will be advised to perform the exercises independently at home. No ongoing digital supervision, tailored feedback, or structured adherence prompts will be provided. |
|
| Baseline; 6 weeks; 18 weeks |
| Muscle strength | Baseline; 6 weeks; 18 weeks |