Unique ID issued by UMIN | UMIN000058301 |
---|---|
Receipt number | R000065319 |
Scientific Title | The Effects of Local Radiofrequency Warming of the Posterior Lower Leg and Plantar Foot on Star Excursion Balance Test (SEBT) Performance and Lower Leg Inclination Angle: A Randomized Crossover Trial |
Date of disclosure of the study information | 2025/06/27 |
Last modified on | 2025/06/27 14:05:22 |
Acute Effects of Radiofrequency-Induced Warming of the Posterior Lower Leg and Foot on Balance Performance and Lower Leg Alignment
RFA-LegBalance Study
The Effects of Local Radiofrequency Warming of the Posterior Lower Leg and Plantar Foot on Star Excursion Balance Test (SEBT) Performance and Lower Leg Inclination Angle: A Randomized Crossover Trial
RFA-SEBT Crossover Trial
Japan |
Healthy Volunteers
Adult |
Others
NO
To investigate the effects of local radiofrequency heating applied to the posterior lower leg and plantar sole on dynamic balance performance, as assessed by the Star Excursion Balance Test (SEBT), and on ankle dorsiflexion range of motion, as assessed by the lower leg forward tilt angle, in healthy adult males.
Others
To evaluate the effect of local radiofrequency heating to the posterior lower leg and plantar sole (intervention) compared to sham heating (control) on the maximum reach distance in the Star Excursion Balance Test (SEBT) as the primary outcome, in a randomized crossover trial involving healthy adult males.
Measure: Maximum reach distance in the three directions (anterior, posteromedial, and posterolateral) of the Star Excursion Balance Test (SEBT)
Timepoints: Immediately before and after each intervention (radiofrequency heating and control condition)
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Active
2
Educational,Counseling,Training
Device,equipment |
Intervention Name: Local heating of the posterior lower leg
Intervention Details:
Intervention: Local heating will be applied to the posterior lower leg (gastrocnemius and soleus muscle region) using a CRET (Capacitive and Resistive Electric Transfer) device, the Physio Radio-Stim Pro (SAKAI Medical Co., Ltd., Tokyo, Japan), operating at a frequency of 500 kHz.
Duration: 2 minutes
Frequency: Single session
Washout Period: A washout period of 1 week will be established before the subsequent intervention (plantar sole heating).
Intervention: Local heating will be applied to the plantar sole (plantar fascia region) using a CRET (Capacitive and Resistive Electric Transfer) device, the Physio Radio-Stim Pro (SAKAI Medical Co., Ltd., Tokyo, Japan), operating at a frequency of 500 kHz.
Duration: 2 minutes
Frequency: Single session
Washout Period: A washout period of 1 week will be established before the subsequent intervention (posterior lower leg heating).
18 | years-old | <= |
49 | years-old | >= |
Male
Individuals who have received a full explanation of the purpose and procedures of the study and have voluntarily provided written informed consent.
Males aged between 18 and 49 years, inclusive.
Individuals who are in good health with no history of serious cardiovascular, hepatic, or renal diseases.
Individuals with no history of orthopedic trauma or surgery to the lower limbs within the past 6 months.
Individuals with no neurological or orthopedic disorders that may affect balance ability.
Individuals with no open wounds or severe skin diseases at the intervention sites.
Individuals with no implanted metal devices (e.g., pacemakers, artificial joints, plates).
Individuals with a history of allergy or hypersensitivity to the gels or creams used for radiofrequency therapy.
Individuals with sensory impairment, such as deficits in temperature or pain sensation, at the intervention sites (posterior lower leg and plantar sole).
Individuals currently taking medications on a regular basis that could potentially affect balance or muscle function (e.g., hypnotics, muscle relaxants, certain antihypertensive drugs).
Individuals who are currently participating in another clinical trial.
Individuals who, in the judgment of the principal investigator, are otherwise considered unsuitable for participation in the study.
30
1st name | Yutaro |
Middle name | |
Last name | Hyodo |
Bukkyo University
Department of Physical Therapy
604-8418
7,Higasitoganoo-cho,Nishinokyo,Nakagyo-ku, Kyoto 604-8418,Japan
075-491-2141
y-hyodo@bukkyo-u.ac.jp
1st name | Yutaro |
Middle name | |
Last name | Hyodo |
Bukkyo University
Department of Physical Therapy
604-8418
7,Higasitoganoo-cho,Nishinokyo,Nakagyo-ku, Kyoto 604-8418,Japan
075-491-2141
y-hyodo@bukkyo-u.ac.jp
Bukkyo University
Yutaro Hyodo
None
Other
Bukkyo University Yutaro Hyodo
7,Higasitoganoo-cho,Nishinokyo,Nakagyo-ku, Kyoto 604-8418,Japan
075-491-2141
y-hyodo@bukkyo-u.ac.jp
NO
2025 | Year | 06 | Month | 27 | Day |
Unpublished
Preinitiation
2025 | Year | 07 | Month | 01 | Day |
2025 | Year | 07 | Month | 01 | Day |
2025 | Year | 12 | Month | 31 | Day |
2025 | Year | 06 | Month | 27 | Day |
2025 | Year | 06 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065319