UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060153 |
|---|---|
| Receipt number | R000068799 |
| Scientific Title | Verification of the Immediate Effects of Vibration Stimulation on the Triceps Surae Muscle in Patients Following Ankle Fracture Surgery |
| Date of disclosure of the study information | 2025/12/22 |
| Last modified on | 2025/12/21 21:18:14 |
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Basic information
Public title
Verification of the Immediate Effects of Vibration Stimulation on the Triceps Surae Muscle in Patients Following Ankle Fracture Surgery
Acronym
Verification of the Immediate Effects of Vibration Stimulation on the Triceps Surae Muscle in Patients Following Ankle Fracture Surgery
Scientific Title
Verification of the Immediate Effects of Vibration Stimulation on the Triceps Surae Muscle in Patients Following Ankle Fracture Surgery
Scientific Title:Acronym
Verification of the Immediate Effects of Vibration Stimulation on the Triceps Surae Muscle in Patients Following Ankle Fracture Surgery
Region
| Japan |
Condition
Condition
Ankle Fracture Surgery
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to verify the effectiveness of vibration stimulation applied to the ipsilateral triceps surae muscle during partial weight-bearing initiation in patients following ankle fracture surgery, specifically regarding improvements in ankle range of motion and the sensation of stiffness during joint movement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual Analogue Scale Pain intensity during the following items is measured using VAS
Pain during ankle dorsiflexion
Pain during ankle plantarflexion
Joint Range of Motion
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Vibration stimulation
Interventions/Control_2
Control
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Postoperative ankle fracture patient
Key exclusion criteria
Individuals with hematoma in the ipsilateral gastrocnemius muscle
Individuals experiencing pain at the site where vibration stimulation is applied
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masanobu |
| Middle name | |
| Last name | Yokochi |
Organization
Takeda General Hospital
Division name
Department of Rehabilitation
Zip code
965-8585
Address
3-27 Yamagamachi, Aizuwakamatsu, Fukushima
TEL
0242275511
masanobu@fmu.ac.jp
Public contact
Name of contact person
| 1st name | M |
| Middle name | |
| Last name | Yokochi |
Organization
Takeda General Hospital
Division name
Department of Rehabilitation
Zip code
965-8585
Address
3-27 Yamagamachi, Aizuwakamatsu, Fukushima
TEL
0242275511
Homepage URL
masanobu@fmu.ac.jp
Sponsor or person
Institute
Takeda General Hospital
Institute
Department
Personal name
Funding Source
Organization
Takeda General Hospital
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Takeda General Hospital
Address
3-27 Yamagamachi, Aizuwakamatsu, Fukushima
Tel
0242275511
masanobu@fmu.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 | 12 | Month | 22 | 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 | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 30 | 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 | 12 | Month | 21 | Day |
Last modified on
| 2025 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068799
