UMIN-CTR Clinical Trial

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

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Basic information

Public title

Acute Effects of Radiofrequency-Induced Warming of the Posterior Lower Leg and Foot on Balance Performance and Lower Leg Alignment

Acronym

RFA-LegBalance Study

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

Scientific Title:Acronym

RFA-SEBT Crossover Trial

Region

Japan


Condition

Condition

Healthy Volunteers

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

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.

Basic objectives2

Others

Basic objectives -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.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

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)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Device,equipment

Interventions/Control_1

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).

Interventions/Control_2

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).

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit

49 years-old >=

Gender

Male

Key inclusion criteria

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).

Key exclusion criteria

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.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Yutaro
Middle name
Last name Hyodo

Organization

Bukkyo University

Division name

Department of Physical Therapy

Zip code

604-8418

Address

7,Higasitoganoo-cho,Nishinokyo,Nakagyo-ku, Kyoto 604-8418,Japan

TEL

075-491-2141

Email

y-hyodo@bukkyo-u.ac.jp


Public contact

Name of contact person

1st name Yutaro
Middle name
Last name Hyodo

Organization

Bukkyo University

Division name

Department of Physical Therapy

Zip code

604-8418

Address

7,Higasitoganoo-cho,Nishinokyo,Nakagyo-ku, Kyoto 604-8418,Japan

TEL

075-491-2141

Homepage URL


Email

y-hyodo@bukkyo-u.ac.jp


Sponsor or person

Institute

Bukkyo University

Institute

Department

Personal name

Yutaro Hyodo


Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Bukkyo University Yutaro Hyodo

Address

7,Higasitoganoo-cho,Nishinokyo,Nakagyo-ku, Kyoto 604-8418,Japan

Tel

075-491-2141

Email

y-hyodo@bukkyo-u.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2025 Year 06 Month 27 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Preinitiation

Date of protocol fixation

2025 Year 07 Month 01 Day

Date of IRB


Anticipated trial start date

2025 Year 07 Month 01 Day

Last follow-up date

2025 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2025 Year 06 Month 27 Day

Last modified on

2025 Year 06 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065319