High-Intensity Focused Electromagnetic Therapy Combined With Foot Core Training for Pronated Foot

NCT06401954 | Recruiting

• 1 other identifier: 202402010RINA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Flexible Flatfoot

Keywords

pronated foot; foot core system; dynamic foot function; high-intensity focused electromagnetic therapy; foot core training

Outcome Measures

Primary Outcomes (1)

• Change from baseline in plantar load at week 6

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

  baseline, week 6

Secondary Outcomes (3)

• Change from baseline in static foot posture at week 6

  baseline, week 6

• Change from baseline in intrinsic foot muscle morphology at week 6

  baseline, week 6

• Change from baseline in intrinsic foot muscle activation at week 6

  baseline, week 6

Study Arms (3)

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.

Device: High-intensity focused electromagnetic therapy; Behavioral: Foot core training

HIFEM

ACTIVE COMPARATOR

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

Behavioral: Foot core training

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.

Behavioral: Foot core training; Device: Sham high-intensity focused electromagnetic therapy

Interventions

High-intensity focused electromagnetic therapy DEVICE

High-intensity focused electromagnetic therapy is applied to intrinsic foot muscles, the intensity is set to stimulate muscle contraction. 20 minutes of intervention, twice a week, and a total of 6 weeks

HIFEM with foot core training

Foot core training BEHAVIORAL

Foot core training will consist of 4 exercises with 10 repetitions per set and 3 sets per session for each exercise. Twice a week for a total of six weeks.

HIFEM; HIFEM with foot core training; Sham HIFEM with foot core training

Sham high-intensity focused electromagnetic therapy DEVICE

Sham high-intensity focused electromagnetic therapy is applied to intrinsic foot muscles, the intensity is unable to stimulate muscle contraction. 20 minutes of intervention, twice a week, and a total of 6 weeks

Sham HIFEM with foot core training

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Related Publications (21)

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MeSH Terms

Conditions

Flatfoot

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Yueh-Hsia Chen, PhD

  National Taiwan University, School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yueh-Hsia Chen, PhD

CONTACT

+886-3366-8133; yuehhsiachen@ntu.edu.tw

Yi-Guo Wang, BS

CONTACT

r11428006@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 7, 2024
• Study Start: May 15, 2024
• Primary Completion: March 15, 2025
• Study Completion: May 15, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)