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临床试验/NCT06958757
NCT06958757尚未招募不适用

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 个研究点目标入组 64 人开始时间: 2025年5月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
64
主要终点
Kujala Anterior Knee Pain Scale

研究概览

简要总结

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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)

排除标准

  • •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

研究组 & 干预措施

experimental group

Experimental

standard exercise + ankle dorsiflexion training

干预措施: Standard Exercise Therapy + Ankle Dorsiflexion Training (Other)

control group

Active Comparator

standard exercise only

干预措施: Standard Exercise Therapy Only (Other)

结局指标

主要结局

Kujala Anterior Knee Pain Scale

时间窗: 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

时间窗: Assess all outcome measures at baseline (pre-intervention) and immediately after the completion of the 8-week intervention program (post-intervention).

次要结局

  • 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).)

研究者

发起方
Tianjin University of Sport
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wu Yuan

Principal Investigator

Tianjin University of Sport

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