UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063049 |
|---|---|
| Receipt number | R000072175 |
| Scientific Title | The Effects of Thermal and Cold Stimuli on the Biomechanical Properties of Skeletal Muscle: A Study Using Ultrasound Imaging for Evaluation |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/09/25 09:44:36 |
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Basic information
Public title
The Acute Effects of Physical Therapy on the Viscoelasticity of Skeletal Muscle
Acronym
RCT on the Acute Effects of Physical Therapy
Scientific Title
The Effects of Thermal and Cold Stimuli on the Biomechanical Properties of Skeletal Muscle: A Study Using Ultrasound Imaging for Evaluation
Scientific Title:Acronym
SWE Assessment of Physical Therapy Outcomes
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Orthopedics | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines the effects of thermal and cold stimuli on muscle elasticity and viscosity. The objective is to determine whether it is possible to evaluate the effectiveness of muscle conditioning that involves temperature manipulation based on muscle elasticity and viscosity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Elasticity and viscosity in skeletal muscles of the limbs measured by shear-wave elastography and a dynamometer. Assessment timing: before and after intervention
Key secondary outcomes
Muscle activity, tissue temperature, range of motion, and exercise performance in the skeletal muscles of the limbs. Assessment timing: before and after intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
A single session of thermal stimulation is administered. The stimulation method uses one of the following: a bath, a pressurized circulation system (GAME READY Med4 Elite, Avanos Medical), an ultrasound therapy device (UST-770, Ito Ultrashort Wave), radiofrequency (Physio Radio Stim PRO, Sakai Medical), or a hot pack (MHR-2f, Minato Medical Science). The stimulation intensity is set appropriately with the goal of changing the skin temperature at the target site by approximately 4 degrees over a 15-minute period.
Interventions/Control_2
A single cold stimulus is administered. The stimulus method uses one of the following: a bath, a pressurized circulation system (GAME READY Med4 Elite, Avanos Medical), ice, or a clicker (PE-50, Takachih Medical). The stimulation intensity is set appropriately with the goal of changing the skin temperature at the target site by approximately 4 degrees over a 15-minute period.
Interventions/Control_3
No intervention. Remain seated and at rest for 15 minutes.
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
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults aged 18 to 35
Individuals who have provided written consent to participate in the study
Key exclusion criteria
Individuals currently experiencing sensory disturbances
Individuals with implanted medical devices, such as metal implants or pacemakers, resulting from surgery or other procedures
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Taiki |
| Middle name | |
| Last name | Kodesho |
Organization
Sapporo Medical University
Division name
Department of Physical Therapy, School of Health Sciences
Zip code
0608556
Address
South-1, West-17, Chuo-Ku, Sapporo, Hokkaido, Japan
TEL
0116112111
kodesho@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Taiki |
| Middle name | |
| Last name | Kodesho |
Organization
Sapporo Medical University
Division name
Department of Physical Therapy, School of Health Sciences
Zip code
0608556
Address
South-1, West-17, Chuo-Ku, Sapporo, Hokkaido, Japan
TEL
0116112111
Homepage URL
kodesho@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University
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
Sapporo Medical University Ethics Committee
Address
South-1, West-17, Chuo-Ku, Sapporo, Hokkaido, Japan
Tel
0116112111
rinri@sapmed.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
| 2026 | Year | 10 | Month | 01 | 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
| 2026 | Year | 09 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | 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
| 2026 | Year | 09 | Month | 25 | Day |
Last modified on
| 2026 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072175
