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Clinical Trials/NCT06958757
NCT06958757Not yet recruitingNot Applicable

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.

Tianjin University of Sport0 sites64 target enrollmentStarted: May 6, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
64
Primary Endpoint
Kujala Anterior Knee Pain Scale

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 30 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

experimental group

Experimental

standard exercise + ankle dorsiflexion training

Intervention: Standard Exercise Therapy + Ankle Dorsiflexion Training (Other)

control group

Active Comparator

standard exercise only

Intervention: Standard Exercise Therapy Only (Other)

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • 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).)

Investigators

Sponsor
Tianjin University of Sport
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Wu Yuan

Principal Investigator

Tianjin University of Sport

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