UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055372 |
|---|---|
| Receipt number | R000062992 |
| Scientific Title | Verification of the effect of trunk flexion training using whole body vibration on the muscle stiffness of the lumbar erector spinae muscles. |
| Date of disclosure of the study information | 2024/08/30 |
| Last modified on | 2024/10/02 09:35:29 |
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Basic information
Public title
Verification of the effect of trunk flexion training with whole-body vibration on the muscle stiffness of the back muscles
Acronym
The effect of trunk flexion training using whole body vibration on the back muscles
Scientific Title
Verification of the effect of trunk flexion training using whole body vibration on the muscle stiffness of the lumbar erector spinae muscles.
Scientific Title:Acronym
Verification of the effect of trunk flexion training using whole body vibration on the lumbar erector spinae muscles
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarify the effects of whole body vibration training
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Erector spinae muscle stiffness
Key secondary outcomes
Lumbar motor control, Lumbar proprioception, erector spinae tenderness threshold
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Combination of whole body vibration and trunk flexion training
Interventions/Control_2
Trunk flexion training only
Interventions/Control_3
Trunk neutral training
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy university student
Key exclusion criteria
1) pain that interfered with daily life; 2) typical physical function impairment, such as paralysis due to cerebrovascular disease; 3) history of surgery that significantly affected spine or hip motion, such as spinal fusion or hip replacement surgery; 4) pronounced spinal deformity; 5) cognitive impairment that prevented them from understanding the study; and 6) pregnancy
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Miyachi |
Organization
Hokuriku University
Division name
Faculty of Medical and Health Sciences
Zip code
9201180
Address
1-1 Taiyogaoka, Kanazawa, Ishikawa
TEL
0762291161
ry_miyachi@hokuriku-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Miyachi |
Organization
Hokuriku University
Division name
Faculty of Medical and Health Sciences
Zip code
9201180
Address
1-1 Taiyogaoka, Kanazawa, Ishikawa
TEL
0762291161
Homepage URL
ry_miyachi@hokuriku-u.ac.jp
Sponsor or person
Institute
Hokuriku University
Institute
Department
Personal name
Funding Source
Organization
Hokuriku University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokuriku University
Address
1-1 Taiyogaoka, Kanazawa, Ishikawa
Tel
0762291161
ry_miyachi@hokuriku-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
| 2024 | Year | 08 | Month | 30 | 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
Completed
Date of protocol fixation
| 2024 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 30 | Day |
Last modified on
| 2024 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062992
