- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06958757
- Original Trial
A Study on the Effectiveness of Ankle Dorsiflexion Range of Motion Training in Patients With Patellofemoral Joint Pain.
This RCT Included 64 Participants (18-30y) With PFP, Ankle Dorsiflexion ROM <10°, and BMI 18.5-28 kg/m². Exclusions: Ankle Fractures, Achilles Rupture, Rheumatoid Arthritis, Gout, Systemic Diseases, or Prior Knee/Ankle Surgeries. Randomized to Two Groups (n=32/Group): Experimental (Standard Exercise + Ankle Dorsiflexion Training) vs Control (Standard Exercise Only) at Matched Intensity/Frequency for 8 Weeks. Outcomes: VAS Pain, Kujala Scale, Ankle Dorsiflexion ROM. Certified Physiotherapists Supervise Sessions. Data Analyzed With SPSS 26.0. The Protocol Complies With the Helsinki Declaration.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: yuan wu
- Phone Number: +8615750642556
- Email: 15750642556@163.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 18-30 years
- Diagnosed with patellofemoral pain (PFP) per clinical guidelines (anterior knee pain aggravated by ≥2 activities: running, squatting, stair climbing)
- Ankle dorsiflexion range of motion (ROM) <10° (measured via goniometer in weight-bearing)
- BMI 18.5-28 kg/m²
- Engage in regular physical activity (≥3 sessions/week)
Exclusion Criteria:
- Ankle fractures
- Achilles tendon rupture
- Rheumatoid arthritis
- Gout, or systemic diseases
- Prior knee/ankle surgeries
- Concurrent lower limb injuries (e.g., ligament tears, meniscal pathology)
- Neurological disorders affecting mobility
- Participation in other lower limb rehabilitation programs within 3 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: experimental group
standard exercise + ankle dorsiflexion training
|
The experimental group receives: Standard Exercise Therapy (30 min/session, 3x/week for 8 weeks): Quadriceps eccentric exercises (e.g., slow step-downs), Hip abductor strengthening (e.g., side-lying leg lifts), and Neuromuscular control drills (e.g., single-leg balance on unstable surfaces). Ankle Dorsiflexion Training (15 min/session, 3x/week for 8 weeks): Mobilization techniques (posterior glides of the talus), Resistance band exercises (dorsiflexion against elastic bands), Progressive Achilles tendon stretching (weight-bearing calf stretches). Exercise progression (resistance/intensity) is adjusted biweekly based on functional assessments. |
|
Active Comparator: control group
standard exercise only
|
Standard Exercise Therapy (30 min/session, 3x/week for 8 weeks): Quadriceps eccentric exercises (e.g., slow step-downs), Hip abductor strengthening (e.g., side-lying leg lifts), and Neuromuscular control drills (e.g., single-leg balance on unstable surfaces). Exercise progression (resistance/intensity) is adjusted biweekly based on functional assessments. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Kujala Anterior Knee Pain Scale
Time Frame: Assess all outcome measures at baseline (pre-intervention) and immediately after the completion of the 8-week intervention program (post-intervention).
|
Assess all outcome measures at baseline (pre-intervention) and immediately after the completion of the 8-week intervention program (post-intervention).
|
|
Ankle dorsiflexion range of motion
Time Frame: Assess all outcome measures at baseline (pre-intervention) and immediately after the completion of the 8-week intervention program (post-intervention).
|
Assess all outcome measures at baseline (pre-intervention) and immediately after the completion of the 8-week intervention program (post-intervention).
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
sEMG co-contraction ratios
Time Frame: All outcome measures (sEMG co-contraction) ratios are assessed at baseline (pre-intervention) and immediately after completing the 8-week intervention program (post-intervention).
|
All outcome measures (sEMG co-contraction) ratios are assessed at baseline (pre-intervention) and immediately after completing the 8-week intervention program (post-intervention).
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TJUS2025-054
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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