UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061412 |
|---|---|
| Receipt number | R000070268 |
| Scientific Title | Effects of Radial Extracorporeal Shock Wave Therapy on Ankle Dorsiflexion Range of Motion: Investigation of Mechanical and Neural/Perceptual Factors Focusing on the Triceps Surae and Kager's Fat Pad |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/04/29 23:56:28 |
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Basic information
Public title
Effects and Mechanisms of Radial Extracorporeal Shock Wave Therapy on Ankle Dorsiflexion Range of Motion
Acronym
Effects of Radial Extracorporeal Shock Wave Therapy on Ankle Dorsiflexion Range of Motion
Scientific Title
Effects of Radial Extracorporeal Shock Wave Therapy on Ankle Dorsiflexion Range of Motion: Investigation of Mechanical and Neural/Perceptual Factors Focusing on the Triceps Surae and Kager's Fat Pad
Scientific Title:Acronym
Effects of Radial Extracorporeal Shock Wave Therapy on Ankle Dorsiflexion Range of Motion: Investigation of Mechanical and Neural/Perceptual Factors
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effects of radial extracorporeal shock wave therapy (rESWT) applied to the triceps surae and Kager's fat pad (KFP) on ankle dorsiflexion range of motion, as well as to elucidate its effects on mechanical and neural/perceptual factors, using changes in passive torque and tissue stiffness as outcome measures.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Maximum ankle dorsiflexion angle, Weight-Bearing Lunge Test (WBLT)
Key secondary outcomes
Hallux dorsiflexion angle, Shear modulus, Passive torque, Slack angle, Stretch tolerance
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Radial extracorporeal shock wave therapy (rESWT) will be applied to the triceps surae and Kager's fat pad (KFP). The treatment parameters will be set at the maximum intensity tolerated by each participant, with a frequency of 12 Hz and 2000 pulses. First, rESWT will be delivered to the triceps surae using a 40-mm applicator, followed by treatment with a 15-mm applicator under the same conditions. Subsequently, rESWT will also be applied to the KFP using a 15-mm applicator under the same conditions.
Interventions/Control_2
Radial extracorporeal shock wave therapy (eESWT) will be applied only to Kager's fat pad (KFP). The treatment parameters will be set at the maximum intensity tolerated by each participant, with a frequency of 12 Hz and a total of 2000 pulses. A 15-mm applicator will be used for the treatment.
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
| 45 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adults with no history of ankle injury within the past 6 months
Key exclusion criteria
Individuals with a history of neurological disorders or a history of surgery involving the trunk or lower extremities
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kota |
| Middle name | |
| Last name | Watanabe |
Organization
Sapporo Medical University
Division name
Department of Sports Medicine, School of Medicine
Zip code
060-8556
Address
School of Health Sciences, Sapporo Medical University, South-1, West-17, Chuo-Ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
wkota@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Chisato |
| Middle name | |
| Last name | Okuizumi |
Organization
Sapporo Medical University Graduate School
Division name
Division of Biomechanics&Sports Orthopedics, Department of Physical Therapy and Occupational Therapy
Zip code
060-8556
Address
School of Health Sciences, Sapporo Medical University, South-1, West-17, Chuo-Ku, Sapporo, Hokkaido,
TEL
011-611-2111
Homepage URL
okuizumi@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University Graduate School
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Sapporo Medical University
Address
School of Health Sciences, Sapporo Medical University, South-1, West-17, Chuo-Ku, Sapporo, Hokkaido
Tel
011-611-2111
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 | 06 | 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 | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2029 | 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 | 04 | Month | 29 | Day |
Last modified on
| 2026 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070268
