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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| HIFEM | Active Comparator | High-intensity focused electromagnetic therapy is used to stimulate intrinsic foot muscles |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in static foot posture at week 6 | Static foot posture is measured by navicular drop test and Foot Posture Index | baseline, week 6 |
| Change from baseline in intrinsic foot muscle morphology at week 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yueh-Hsia Chen, PhD | National Taiwan University, School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18822155 | Background | Redmond AC, Crane YZ, Menz HB. Normative values for the Foot Posture Index. J Foot Ankle Res. 2008 Jul 31;1(1):6. doi: 10.1186/1757-1146-1-6. | |
| 25595429 | Background | Toullec E. Adult flatfoot. Orthop Traumatol Surg Res. 2015 Feb;101(1 Suppl):S11-7. doi: 10.1016/j.otsr.2014.07.030. Epub 2015 Jan 13. |
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| 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. |
|
| 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 |
|
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
| baseline, week 6 |
| Change from baseline in intrinsic foot muscle activation at week 6 | Intrinsic foot muscle activation is measured by electromyography, and data is collected during walking | baseline, week 6 |
| 25558288 | Background | Neal BS, Griffiths IB, Dowling GJ, Murley GS, Munteanu SE, Franettovich Smith MM, Collins NJ, Barton CJ. Foot posture as a risk factor for lower limb overuse injury: a systematic review and meta-analysis. J Foot Ankle Res. 2014 Dec 19;7(1):55. doi: 10.1186/s13047-014-0055-4. eCollection 2014. |
| 2375632 | Background | Claus D, Waddy HM, Harding AE, Murray NM, Thomas PK. Hereditary motor and sensory neuropathies and hereditary spastic paraplegia: a magnetic stimulation study. Ann Neurol. 1990 Jul;28(1):43-9. doi: 10.1002/ana.410280109. |
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| 9119823 | Background | Cavanagh PR, Morag E, Boulton AJ, Young MJ, Deffner KT, Pammer SE. The relationship of static foot structure to dynamic foot function. J Biomech. 1997 Mar;30(3):243-50. doi: 10.1016/s0021-9290(96)00136-4. |
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| ID | Term |
|---|---|
| D005413 | Flatfoot |
| ID | Term |
|---|---|
| D000070558 | Talipes |
| D005531 | Foot Deformities, Acquired |
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
| D005532 | Foot Deformities, Congenital |
| D038061 | Lower Extremity Deformities, Congenital |
| D017880 | Limb Deformities, Congenital |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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