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Clinical Trials/NCT06401954
NCT06401954CompletedNot Applicable

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 site in 1 country30 target enrollmentStarted: May 15, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
Change from baseline in plantar load at week 6

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • 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

Arms & Interventions

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.

Intervention: 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.

Intervention: Foot core training (Behavioral)

HIFEM

Active Comparator

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

Intervention: 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.

Intervention: 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.

Intervention: Sham high-intensity focused electromagnetic therapy (Device)

Outcomes

Primary Outcomes

Change from baseline in plantar load at week 6

Time Frame: baseline, week 6

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

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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