UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062026 |
|---|---|
| Receipt number | R000070976 |
| Scientific Title | The Effect of Extracorporeal Shock Wave Therapy on the Gluteus Medius Muscle in Patients with Chronic Ankle Instability |
| Date of disclosure of the study information | 2026/07/01 |
| Last modified on | 2026/06/23 13:18:34 |
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Basic information
Public title
The Effect of Extracorporeal Shock Wave Therapy on the Gluteus Medius Muscle in Patients with Chronic Ankle Instability
Acronym
The Effect of Extracorporeal Shock Wave Therapy on the Gluteus Medius Muscle in Patients with Chronic Ankle Instability
Scientific Title
The Effect of Extracorporeal Shock Wave Therapy on the Gluteus Medius Muscle in Patients with Chronic Ankle Instability
Scientific Title:Acronym
The Effect of Extracorporeal Shock Wave Therapy on the Gluteus Medius Muscle in Patients with Chronic Ankle Instability
Region
| Japan |
Condition
Condition
Patients with Chronic Ankle Instability
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects of Shock Waves on the Vastus Medialis on Dynamic Performance, Muscle Strength, and Stability
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dynamic Performance, Muscle Strength, and Stability Before and After the Intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
extracorporeal shock waves
Interventions/Control_2
Sham
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with a history of ankle sprains who meet the criteria for chronic ankle instability as determined by the CAIT questionnaire
Key exclusion criteria
low back pain, skin problems, bleeding tendencies, severe neurological symptoms, or fever or illness on the day of the procedure
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Michio |
| Middle name | |
| Last name | Wachi |
Organization
Bukkyo University
Division name
Department of Physical Therapy
Zip code
5270145
Address
7, Higashi-Togano-cho, Nishinokyo, Nakagyo-ku, Kyoto
TEL
0754912141
m-wachi@bukkyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Michio |
| Middle name | |
| Last name | Wachi |
Organization
Bukkyo Univertity
Division name
Department of Physical Therapy
Zip code
5270145
Address
7, Higashi-Togano-cho, Nishinokyo, Nakagyo-ku, Kyoto
TEL
08031379862
Homepage URL
m-wachi@bukkyo-u.ac.jp
Sponsor or person
Institute
Furu Clinic
Institute
Department
Personal name
Funding Source
Organization
The Japanese Clinical Orthopaedic Association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Bukkyo University
Name of secondary funder(s)
Bukkyo University
IRB Contact (For public release)
Organization
Bukkyo University
Address
96 Murasakino Kita Hanabo-cho, Kita Ward, Kyoto City
Tel
0754912141
m-wachi@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
| 2026 | Year | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 05 | 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 | 06 | Month | 23 | Day |
Last modified on
| 2026 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070976
