- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07811674
Plantar Stimulation, Whole-Body Vibration, and Baduanjin for Muscle Activation
Study on the Activation Effect of Vibration Training Under Plantar Stimulation and Baduanjin on Lower Limb Muscles
This study will examine how different short-term exercise and vibration conditions affect lower-limb muscle activity in young adults with flat feet and young adults with normal feet.
Participants will complete several conditions, including whole-body vibration, whole-body vibration combined with plantar stimulation under different areas of the foot, and a Baduanjin heel-raise exercise. Surface electromyography sensors will be placed on the skin over selected lower-limb muscles to record muscle activity before and during each condition. Each participant will complete all study conditions in a balanced order.
This study does not aim to treat flat feet or evaluate long-term clinical benefits. The purpose is to collect preliminary information on immediate muscle activation and foot discomfort, which may help design future studies on foot-related exercise, plantar stimulation, and rehabilitation training.
Přehled studie
Postavení
Detailní popis
This is a prospective, exploratory, self-controlled crossover study designed to investigate the immediate effects of different exercise and vibration-based conditions on lower-limb muscle activation.
Flat feet may be associated not only with structural changes of the foot arch, but also with altered neuromuscular control of the lower limb. Whole-body vibration provides a standardized mechanical stimulus, while Baduanjin heel-raise exercise represents an active movement-based training condition. Because the plantar surface is an important sensory input area, this study will also examine whether adding regional plantar stimulation to whole-body vibration produces different muscle activation patterns compared with whole-body vibration alone.
Participants will be classified as having flat feet or normal feet based on foot type assessment. Each participant will complete all study conditions in a balanced order, including whole-body vibration alone, whole-body vibration combined with stimulation of different plantar regions, and Baduanjin heel-raise exercise. Surface electromyography will be used to record lower-limb muscle activity before and during each condition.
This study is not designed to evaluate treatment efficacy or long-term clinical outcomes. Its purpose is to collect preliminary mechanistic data on immediate neuromuscular responses, which may inform future studies on plantar stimulation, vibration training, and individualized rehabilitation strategies.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: chao chen, PhD
- Telefonní číslo: +86-20-62787238
- E-mail: chenchao@smu.edu.cn
Studijní místa
-
-
Guangdong
-
Guangzhou, Guangdong, Čína, 510515
- Nábor
- Nanfang Hospital, Southern Medical University
-
Vrchní vyšetřovatel:
- chao chen, PhD
-
Kontakt:
- YiJian Li, PhD
- Telefonní číslo: +86-20-62787238
- E-mail: nfyyec@163.com
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- College students aged 18 to 25, regardless of gender
- agree to participate in the study and voluntarily sign the informed consent form
- and are deemed suitable to participate in this study by the researchers.
Exclusion Criteria:
- Persons with severe cardiovascular diseases, motor dysfunction or cognitive disorders
- persons who have suffered severe trauma or been hospitalized recently and are unsuitable for exercise testing
- persons with congenital lower limb or spinal deformities affecting foot posture other than flatfoot
- persons with a medical history of muscular, neurological or skeletal system disorders affecting foot posture other than flatfoot
- persons deemed ineligible to participate in this study by the investigators
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Nerandomizované
- Intervenční model: Crossover Assignment
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Flatfoot Group
Participants will complete three types of study conditions. In the whole-body vibration (WBV) condition, they will stand barefoot at the center of the vibration platform with feet about 20 cm apart, knees flexed at 20°-25°, arms relaxed, head and neck neutral, eyes forward, and body weight evenly distributed. WBV will be delivered at 20 Hz and 2 mm for 60 seconds. For WBV plus regional plantar stimulation, the same posture and WBV parameters will be used. A plantar stimulation module will be placed on the platform, and participants will position the assigned plantar region on the module. Four regions will be stimulated separately: toe region, metatarsal head region, medial plantar/tibial-side region, and lateral plantar/fibular-side region. Each condition will last 60 seconds. For the Baduanjin condition, participants will perform the "Bei Hou Qi Dian Bai Bing Xiao" heel-raise movement under professional guidance, with 6 repetitions completed within 60 seconds. |
Jiný: Whole-body Vibration Training,Whole-Body Vibration With Regional Plantar Stimulation,Baduanjin
Participants will complete three types of intervention conditions.
In the whole-body vibration condition, participants will stand barefoot on a vibration platform with feet about 20 cm apart and knees flexed at 20°-25°.
Vibration will be delivered at 20 Hz and 2 mm for 60 seconds.
In the whole-body vibration with regional plantar stimulation condition, the same vibration parameters and posture will be used, while a plantar stimulation module is placed on the platform.
Four plantar regions will be stimulated separately: the toe region, metatarsal head region, medial plantar region, and lateral plantar region.
In the Baduanjin condition, participants will perform a heel-raise movement derived from Baduanjin under professional guidance, completing six repetitions within 60 seconds.
|
|
Aktivní komparátor: Normal Foot Group
Participants will complete three types of study conditions. In the whole-body vibration (WBV) condition, they will stand barefoot at the center of the vibration platform with feet about 20 cm apart, knees flexed at 20°-25°, arms relaxed, head and neck neutral, eyes forward, and body weight evenly distributed. WBV will be delivered at 20 Hz and 2 mm for 60 seconds. For WBV plus regional plantar stimulation, the same posture and WBV parameters will be used. A plantar stimulation module will be placed on the platform, and participants will position the assigned plantar region on the module. Four regions will be stimulated separately: toe region, metatarsal head region, medial plantar/tibial-side region, and lateral plantar/fibular-side region. Each condition will last 60 seconds. For the Baduanjin condition, participants will perform the "Bei Hou Qi Dian Bai Bing Xiao" heel-raise movement under professional guidance, with 6 repetitions completed within 60 seconds. |
Jiný: Whole-body Vibration Training,Whole-Body Vibration With Regional Plantar Stimulation,Baduanjin
Participants will complete three types of intervention conditions.
In the whole-body vibration condition, participants will stand barefoot on a vibration platform with feet about 20 cm apart and knees flexed at 20°-25°.
Vibration will be delivered at 20 Hz and 2 mm for 60 seconds.
In the whole-body vibration with regional plantar stimulation condition, the same vibration parameters and posture will be used, while a plantar stimulation module is placed on the platform.
Four plantar regions will be stimulated separately: the toe region, metatarsal head region, medial plantar region, and lateral plantar region.
In the Baduanjin condition, participants will perform a heel-raise movement derived from Baduanjin under professional guidance, completing six repetitions within 60 seconds.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Root Mean Square Value
Časové okno: Day 1: from the resting baseline immediately before each intervention condition through completion of that intervention condition.
|
Electrodes were placed per SENIAM standards (2000 Hz sampling, 20-450 Hz band-pass and 50 Hz band-stop filtering).
Data were collected during a 30 s resting baseline and the 30-60 s stable phase of intervention.
After offline full-wave rectification, RMS was calculated using a 200 ms sliding window (100 ms step).
Mean RMS within each epoch was adopted as the representative value.
|
Day 1: from the resting baseline immediately before each intervention condition through completion of that intervention condition.
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Integrated Electromyography
Časové okno: Day 1: from the resting baseline immediately before each intervention condition through completion of that intervention condition.
|
discharge during the resting baseline phase (stable signals for 60 consecutive seconds) before each intervention mode and the entire intervention period (60 seconds) during intervention, namely the area under the curve of electromyographic signals after full-wave rectification, which reflects the overall activation level.
|
Day 1: from the resting baseline immediately before each intervention condition through completion of that intervention condition.
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: chao chen, PhD, Nanfang Hospital, Southern Medical University
Publikace a užitečné odkazy
Obecné publikace
- Ritzmann R, Gollhofer A, Kramer A. The influence of vibration type, frequency, body position and additional load on the neuromuscular activity during whole body vibration. Eur J Appl Physiol. 2013 Jan;113(1):1-11. doi: 10.1007/s00421-012-2402-0. Epub 2012 Apr 27.
- Segura A, Donly KJ, Stratmann RG. Enamel remineralization on teeth adjacent to Class II glass ionomer restorations. Am J Dent. 1997 Oct;10(5):247-50.
- Kirmizi M, Sengul YS, Akcali O, Angin S. Effects of foot exercises and customized arch support insoles on foot posture, plantar force distribution, and balance in people with flexible flatfoot: A randomized controlled trial. Gait Posture. 2024 Sep;113:106-114. doi: 10.1016/j.gaitpost.2024.05.030. Epub 2024 Jun 2.
- Salinas-Torres VM, Salinas-Torres RA, Carranza-Garcia LE, Herrera-Orozco J, Tristan-Rodriguez JL. Prevalence and Clinical Factors Associated With Pes Planus Among Children and Adults: A Population-Based Synthesis and Systematic Review. J Foot Ankle Surg. 2023 Sep-Oct;62(5):899-903. doi: 10.1053/j.jfas.2023.05.007. Epub 2023 Jun 5.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- NFEC-2026-561
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .