A Study on the Effectiveness of Ankle Dorsiflexion Range of Motion Training in Patients With Patellofemoral Joint Pain.

April 25, 2025 updated by: Wu Yuan, Tianjin University of Sport

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).

Study Overview

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 6, 2025

Primary Completion (Estimated)

September 10, 2025

Study Completion (Estimated)

September 10, 2025

Study Registration Dates

First Submitted

April 19, 2025

First Submitted That Met QC Criteria

April 25, 2025

First Posted (Actual)

May 6, 2025

Study Record Updates

Last Update Posted (Actual)

May 6, 2025

Last Update Submitted That Met QC Criteria

April 25, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • TJUS2025-054

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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