UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044674 |
|---|---|
| Receipt number | R000051022 |
| Scientific Title | The relationship between Motion of head/neck and trunk and spinal degeneration and instability |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2021/12/27 18:10:37 |
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Basic information
Public title
The relationship between Motion of head/neck and trunk and spinal degeneration and instability
Acronym
The relationship between Motion of head/neck and trunk and spinal degeneration and instability
Scientific Title
The relationship between Motion of head/neck and trunk and spinal degeneration and instability
Scientific Title:Acronym
The relationship between Motion of head/neck and trunk and spinal degeneration and instability
Region
| Japan |
Condition
Condition
Neurosurgical outpatients
Classification by specialty
| Neurosurgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Revealing the relationship between Motion of head/neck and trunk and spinal degeneration and instability
Basic objectives2
Others
Basic objectives -Others
Revealing the relationship between motion analysis data and radiological data
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Obtaining the relationship between motion analysis data and radiological data
Key secondary outcomes
Obtaining the data on Oswestry Disability Index, Neck Disability Index, and SF36
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
motion analysis by motion capture system
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Neurosurgical patients coming to the Department of Neurological surgery, Okayama University Hospital during the period from the approval by the Ethics Committee to August 31, 2023 are eligible
Key exclusion criteria
N/A
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takao |
| Middle name | |
| Last name | Yasuhara |
Organization
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name
Department of Neurological Surgery
Zip code
700-8558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
TEL
0862357336
tyasu37@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Yasuhara |
Organization
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name
Department of Neurological Surgery
Zip code
700-8558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
TEL
0862357336
Homepage URL
tyasu37@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Our Own
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
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan.
Tel
0862356503
mae6605@adm.okayama-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
| 2021 | Year | 09 | 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
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 08 | 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
| 2021 | Year | 06 | Month | 27 | Day |
Last modified on
| 2021 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051022
