High-Intensity Focused Electromagnetic Therapy Combined With Foot Core Training for Pronated Foot
- Conditions
- Flexible Flatfoot
- Interventions
- Behavioral: Foot core trainingDevice: High-intensity focused electromagnetic therapyDevice: Sham high-intensity focused electromagnetic therapy
- Registration Number
- NCT06401954
- Lead Sponsor
- National Taiwan University Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- Age ≥ 20 years old
- Navicular drop test ≥ 10 mm
- Foot Posture Index ≥ 6
- Foot and ankle range of motion within normal limits
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham HIFEM with foot core training Foot core training 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. HIFEM Foot core training High-intensity focused electromagnetic therapy is used to stimulate intrinsic foot muscles Sham HIFEM with foot core training Sham high-intensity focused electromagnetic therapy 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. HIFEM with foot core training High-intensity focused electromagnetic therapy 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. HIFEM with foot core training Foot core training 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.
- Primary Outcome Measures
Name Time Method Change from baseline in plantar load at week 6 baseline, week 6 Plantar load is measured by in-shoe pressure measurement system, and the data is collected during walking.
- Secondary Outcome Measures
Name Time Method Change from baseline in intrinsic foot muscle morphology at week 6 baseline, week 6 Intrinsic foot muscle morphology is measured by ultrasonography, include measurements of thickness of abductor hallucis, flexor hallucis brevis and flexor digitorum brevis, and cross-sectional area of abductor hallucis
Change from baseline in static foot posture at week 6 baseline, week 6 Static foot posture is measured by navicular drop test and Foot Posture Index
Change from baseline in intrinsic foot muscle activation at week 6 baseline, week 6 Intrinsic foot muscle activation is measured by electromyography, and data is collected during walking
Trial Locations
- Locations (1)
National Taiwan University Hospital
🇨🇳Taipei, Taiwan