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临床试验/NCT06401954
NCT06401954已完成不适用

Effects of High-Intensity Focused Electromagnetic Therapy Combined With Foot Core Training on Dynamic Foot Function in Individuals With Pronated Foot

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年5月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Change from baseline in plantar load at week 6

研究概览

简要总结

The objective of this trial is to assess the effects of high-intensity focused electromagnetic therapy combined with foot core training targeting the intrinsic foot muscles on plantar load, static foot posture, intrinsic foot muscle morphology and intrinsic foot muscle activation in individuals with pronated foot.

The main questions it aims to answer are:

Question 1: To compare changes in plantar load following interventions of high-intensity focused electromagnetic therapy combined with foot core training, high-intensity focused electromagnetic therapy alone, and sham high-intensity focused electromagnetic therapy combined with foot core training.

Question 2: To compare changes in static foot posture, intrinsic foot muscle morphology, and intrinsic foot muscle activation following interventions of high-intensity focused electromagnetic therapy combined with foot core training, high-intensity focused electromagnetic therapy alone, and sham high-intensity focused electromagnetic therapy combined with foot core training.

Question 3: To assess the effects of each intervention on plantar load, static foot posture, intrinsic foot muscle morphology, and intrinsic foot muscle activation in individuals with pronated foot.

Participants will undergo stimulation of their intrinsic foot muscles through high-intensity focused electromagnetic therapy, and they will also be required to isometrically contract their intrinsic foot muscles during the designated exercise program. Researchers will assess the effects of high-intensity focused electromagnetic therapy combined with foot core training by evaluating plantar load during walking, static foot posture, intrinsic foot muscle morphology and intrinsic foot muscle activation during walking.

详细描述

The objective of this trial is to assess the effects of high-intensity focused electromagnetic therapy combined with foot core training targeting the intrinsic foot muscles on plantar load, static foot posture, intrinsic foot muscle morphology and intrinsic foot muscle activation in individuals with pronated foot.

The main questions it aims to answer are:

Question 1: To compare changes in plantar load following interventions of high-intensity focused electromagnetic therapy combined with foot core training, high-intensity focused electromagnetic therapy alone, and sham high-intensity focused electromagnetic therapy combined with foot core training.

Question 2: To compare changes in static foot posture, intrinsic foot muscle morphology, and intrinsic foot muscle activation following interventions of high-intensity focused electromagnetic therapy combined with foot core training, high-intensity focused electromagnetic therapy alone, and sham high-intensity focused electromagnetic therapy combined with foot core training.

Question 3: To assess the effects of each intervention on plantar load, static foot posture, intrinsic foot muscle morphology, and intrinsic foot muscle activation in individuals with pronated foot.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 20 years old
  • Navicular drop test ≥ 10 mm
  • Foot Posture Index ≥ 6
  • Foot and ankle range of motion within normal limits

排除标准

  • Rigid flatfoot
  • Any congenital deformity of lower extremity
  • Leg length discrepancy > 10 mm
  • Lower extremity injuries or surgeries in recent 6 months
  • Neurological deficits
  • Contraindications of high-intensity focused electromagnetic therapy: pregnancy, unhealed wound, implanted electronic devices or other metal implants

研究组 & 干预措施

HIFEM with foot core training

Experimental

High-intensity focused electromagnetic therapy is used to stimulate intrinsic foot muscles, and foot core training is performed with intrinsic foot muscle isometric contraction exercise.

干预措施: High-intensity focused electromagnetic therapy (Device)

HIFEM with foot core training

Experimental

High-intensity focused electromagnetic therapy is used to stimulate intrinsic foot muscles, and foot core training is performed with intrinsic foot muscle isometric contraction exercise.

干预措施: Foot core training (Behavioral)

HIFEM

Active Comparator

High-intensity focused electromagnetic therapy is used to stimulate intrinsic foot muscles

干预措施: Foot core training (Behavioral)

Sham HIFEM with foot core training

Sham Comparator

Sham high-intensity focused electromagnetic therapy is applied on intrinsic foot muscles, and foot core training is performed with intrinsic foot muscle isometric contraction exercise.

干预措施: Foot core training (Behavioral)

Sham HIFEM with foot core training

Sham Comparator

Sham high-intensity focused electromagnetic therapy is applied on intrinsic foot muscles, and foot core training is performed with intrinsic foot muscle isometric contraction exercise.

干预措施: Sham high-intensity focused electromagnetic therapy (Device)

结局指标

主要结局

Change from baseline in plantar load at week 6

时间窗: baseline, week 6

Plantar load is measured by in-shoe pressure measurement system, and the data is collected during walking.

次要结局

  • Change from baseline in intrinsic foot muscle morphology at week 6(baseline, week 6)
  • Change from baseline in static foot posture at week 6(baseline, week 6)
  • Change from baseline in intrinsic foot muscle activation at week 6(baseline, week 6)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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