UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057505 |
|---|---|
| Receipt number | R000065707 |
| Scientific Title | The effect of local vibration intervention on the plantar flexor muscles during the fixation period in postoperative patients with an ankle fracture |
| Date of disclosure of the study information | 2025/04/04 |
| Last modified on | 2025/04/03 22:17:01 |
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Basic information
Public title
The effect of local vibration intervention on the plantar flexor muscles during the fixation period in postoperative patients with an ankle fracture
Acronym
The effect of local vibration intervention on the plantar flexor muscles during the fixation period in postoperative patients with an ankle fracture
Scientific Title
The effect of local vibration intervention on the plantar flexor muscles during the fixation period in postoperative patients with an ankle fracture
Scientific Title:Acronym
The effect of local vibration intervention on the plantar flexor muscles during the fixation period in postoperative patients with an ankle fracture
Region
| Japan |
Condition
Condition
Patient with ankle fracture
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Ankle joint fractures are one of the most common types of lower limb fracture. After surgery, the ankle joint is often immobilized in a plantar flexion position, and there have been many reports of cases where the range of motion of the ankle joint is limited. The purpose of this study was to investigate the effect of regular vibration intervention on the range of motion of the ankle joint after removal of the immobilization.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The main objective of this study is to investigate whether or not 3 minutes of vibration intervention to the plantar flexor muscles of the ankle joint during plaster immobilization in patients after ankle joint surgery can improve the range of motion of the ankle joint after removal of the immobilization.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Vibration intervention was administered by a physical therapist using a cordless hand massager. The Vib was applied perpendicularly to the plantar flexor muscles, which were exposed at the site of the splint. The Vib was applied to the entire surface of the plantar flexor muscles. The subject was placed in the supine position on the bed, and a towel was placed at the distal end of the lower leg so that the operated leg was raised off the bed. The Vibration intervention was set at 45 Hz, and 3 minutes per session was performed twice a day.
Interventions/Control_2
After ankle joint fracture surgery, the patient underwent regular physical therapy.
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
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with ankle fractures who suffered an ankle fracture and were admitted to our hospital for surgical fixation
Key exclusion criteria
The exclusion criteria were as follows: those who did not consent to the purpose of this study, and those with severe motor paralysis due to stroke or other causes.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masanobu |
| Middle name | |
| Last name | Yokoc |
Organization
Takeda General Hospital
Division name
Department of Rehabilitation
Zip code
965-8585
Address
3-27 Yamagamachi, Aizuwakamatsu, Fukushima
TEL
0242275511
masanobu3250@gmail.com
Public contact
Name of contact person
| 1st name | Masanobu |
| Middle name | |
| Last name | Y |
Organization
Takeda General Hospital
Division name
Department of Rehabilitation
Zip code
965-8585
Address
3-27 Yamagamachi, Aizuwakamatsu, Fukushima
TEL
0242275511
Homepage URL
masanobu3250@gmail.com
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
masanobu3250@gmail.com
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 | 04 | Month | 04 | 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
27
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
Completed
Date of protocol fixation
| 2022 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 20 | 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 | 04 | Month | 03 | Day |
Last modified on
| 2025 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065707
