Clinical trial NCT06401954: High-Intensity Focused Electromagnetic Therapy Combined With Foot Core Training for Pronated Foot
Official title: Effects of High-Intensity Focused Electromagnetic Therapy Combined With Foot Core Training on Dynamic Foot Function in Individuals With Pronated Foot
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Flexible Flatfoot
Keywords: pronated foot
foot core system
dynamic foot function
high-intensity focused electromagnetic therapy
foot core training
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-05-07
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligible participants will be randomly assigned to one of three groups: the high-intensity focused electromagnetic therapy combined with foot core training group, the high-intensity focused electromagnetic therapy group, or the sham high-intensity focused electromagnetic therapy combined with foot core training group.

High-intensity focused electromagnetic therapy sessions will last for 20 minutes each, while the foot core training program will comprise 4 exercises, with 10 repetitions per set and 3 sets per session for each exercise. Participants will undergo these interventions twice a week over a 6-week period.

Plantar load and electromyographic signals of the abductor hallucis muscle during gait, ultrasonography for morphological analysis of the intrinsic foot muscles, and static foot posture will be evaluated at baseline and 6 weeks following the intervention.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in plantar load at week 6
timeFrame: baseline, week 6
Secondary outcomes:
measure: Change from baseline in static foot posture at week 6
timeFrame: baseline, week 6
measure: Change from baseline in intrinsic foot muscle morphology at week 6
timeFrame: baseline, week 6
measure: Change from baseline in intrinsic foot muscle activation at week 6
timeFrame: baseline, week 6
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University, School of Medicine
name: Yueh-Hsia Chen, PhD
role: PRINCIPAL_INVESTIGATOR
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