Patellofemoral Pain, PFPNCT06958757
A Study on the Effectiveness of Ankle Dorsiflexion Range of Motion Training in Patients With Patellofemoral Joint Pain.
A study testing Standard Exercise Therapy + Ankle Dorsiflexion Training and Standard Exercise Therapy Only in people with Patellofemoral Pain, PFP, run by Tianjin University of Sport.
Trial summary
Patellofemoral Pain (PFP) is a common knee condition causing pain around the kneecap during activities like running or squatting. Limited ankle flexibility ("dorsiflexion" - how far participants can lift their toes toward the shin) may worsen PFP by altering leg movements. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Patellofemoral Pain, PFP
- What is being tested?
- Standard Exercise Therapy + Ankle Dorsiflexion Training and Standard Exercise Therapy Only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 6 May 2025to 10 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Patellofemoral Pain (PFP) is a common knee condition causing pain around the kneecap during activities like running or squatting. Limited ankle flexibility ("dorsiflexion" - how far participants can lift their toes toward the shin) may worsen PFP by altering leg movements. This study investigates whether adding ankle flexibility exercises to standard knee-strengthening programs improves outcomes for young adults with PFP. Active adults aged 18-30 with PFP and limited ankle flexibility (measured with a simple tool) are eligible, excluding those with prior knee/ankle surgeries, fractures, or conditions like arthritis. Sixty-four participants will be randomly assigned to either an Exercise + Ankle Training group (standard knee exercises plus targeted ankle training) or an Exercise-Only group for 8 weeks under physiotherapist guidance. Outcomes include improvements in knee pain scores (Kujala Scale), ankle flexibility changes, and muscle coordination measured with non-invasive sensors. If effective, ankle flexibility training could provide a low-cost addition to current treatments, helping patients resume activities with less pain. The study follows international ethical guidelines and has received preliminary ethics approval (No. TJUS-2025-054).
- Conditions
- Patellofemoral Pain, PFP
- Being tested
- Standard Exercise Therapy + Ankle Dorsiflexion Training, Standard Exercise Therapy Only
- 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.
Standard Exercise Therapy + Ankle Dorsiflexion TrainingOther
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.
Standard Exercise Therapy OnlyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | standard exercise + ankle dorsiflexion training Receives: Other: Standard Exercise Therapy + Ankle Dorsiflexion Training |
| control group | Active comparator | standard exercise only Receives: Other: Standard Exercise Therapy Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kujala Anterior Knee Pain Scale
Measured: 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
Measured: Assess all outcome measures at baseline (pre-intervention) and immediately after the completion of the 8-week intervention program (post-intervention).
Secondary outcomes (1)
sEMG co-contraction ratios
Measured: All outcome measures (sEMG co-contraction) ratios are assessed at baseline (pre-intervention) and immediately after completing the 8-week intervention program (post-intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start6 May 2025 (estimated)
- Primary completion10 Sep 2025 (estimated)
- Study completion10 Sep 2025 (estimated)
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
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin University of Sport
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wu Yuan, Tianjin University of Sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958757
- Sponsor's protocol ID
- TJUS2025-054
- Status last verified
- Apr 2025
- First submitted
- 19 Apr 2025
- Last updated
- 6 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06958757
- Acronym / sponsor ID
- TJUS2025-054
- Conditions
- Patellofemoral Pain, PFP
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Tianjin University of SportUniversity, hospital or other
- Study start
- 6 May 2025 (estimated)
- Primary completion
- 10 Sep 2025 (estimated)
- Study completion
- 10 Sep 2025 (estimated)
- First posted
- 6 May 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 a common knee condition causing pain around the kneecap during activities like running or squatting. Limited ankle flexibility ("dorsiflexion" - how far participants can lift their toes toward the shin) may worsen PFP by altering leg movements. This study investigates whether adding ankle flexibility exercises to standard knee-strengthening programs improves outcomes for young adults with PFP. Active adults aged 18-30 with PFP and limited ankle flexibility (measured with a simple tool) are eligible, excluding those with prior knee/ankle surgeries, fractures, or conditions like arthritis. Sixty-four participants will be randomly assigned to either an Exercise + Ankle Training group (standard knee exercises plus targeted ankle training) or an Exercise-Only group for 8 weeks under physiotherapist guidance. Outcomes include improvements in knee pain scores (Kujala Scale), ankle flexibility changes, and muscle coordination measured with non-invasive sensors. If effective, ankle flexibility training could provide a low-cost addition to current treatments, helping patients resume activities with less pain. The study follows international ethical guidelines and has received preliminary ethics approval (No. TJUS-2025-054).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: Standard Exercise Therapy + Ankle Dorsiflexion Trainingstandard exercise + ankle dorsiflexion training |
| control group | Active comparator | Other: Standard Exercise Therapy Onlystandard exercise only |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (8 listed)
- Ankle fractures
- Achilles tendon rupture
- Rheumatoid arthritis
- Gout, or systemic diseases
- Prior knee/ankle surgeries
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 |
|---|---|---|
| Standard Exercise Therapy + Ankle Dorsiflexion TrainingThe 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. | Other | experimental group |
| Standard Exercise Therapy OnlyStandard 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. | Other | control group |
Primary outcome
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).
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).
1 secondary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Exercise Therapy + Ankle Dorsiflexion Training and Standard Exercise Therapy Only in people with Patellofemoral Pain, PFP, run by Tianjin University of Sport.
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 8 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: opening soon, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yuan wu (+8615750642556, 15750642556@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 2 primary outcomes in all. 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 6 May 2025.