NCT06958757

Brief 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. 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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 6, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

May 6, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2025

Completed
Last Updated

May 6, 2025

Status Verified

April 1, 2025

Enrollment Period

4 months

First QC Date

April 19, 2025

Last Update Submit

April 25, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Kujala Anterior Knee Pain Scale

    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

    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

    All outcome measures (sEMG co-contraction) ratios are assessed at baseline (pre-intervention) and immediately after completing the 8-week intervention program (post-intervention).

Study Arms (2)

experimental group

EXPERIMENTAL

standard exercise + ankle dorsiflexion training

Other: Standard Exercise Therapy + Ankle Dorsiflexion Training

control group

ACTIVE COMPARATOR

standard exercise only

Other: Standard Exercise Therapy Only

Interventions

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.

experimental group

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.

control group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 19, 2025

First Posted

May 6, 2025

Study Start

May 6, 2025

Primary Completion

September 10, 2025

Study Completion

September 10, 2025

Last Updated

May 6, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share