UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023346 |
|---|---|
| Receipt number | R000026903 |
| Scientific Title | Analysis of ROM limitation of spine by four types of lumbo-sacral orthosis for conservative treatment of spondylolysis |
| Date of disclosure of the study information | 2016/07/26 |
| Last modified on | 2020/07/29 13:46:25 |
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Basic information
Public title
Analysis of ROM limitation of spine by four types of lumbo-sacral orthosis for conservative treatment of spondylolysis
Acronym
Analysis of ROM limitation of spine by four types of lumbo-sacral orthosis for conservative treatment of spondylolysis
Scientific Title
Analysis of ROM limitation of spine by four types of lumbo-sacral orthosis for conservative treatment of spondylolysis
Scientific Title:Acronym
Analysis of ROM limitation of spine by four types of lumbo-sacral orthosis for conservative treatment of spondylolysis
Region
| Japan |
Condition
Condition
spondylolysis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study was designed to assess the role of lumbo-sacral orthoses for conservative treatment of spondylolysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
range of mortion of spine with lumbo-sacral orthosis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
measurement of ROM of spine with 4types of lumbo-sacral orthosis; elastic band, Damen dorset, elastic band with molded back support, full molded corset / frequency: 1 time for each type of lumbo-sacral orthosis / duration: 15 min for each type of lumbo-sacral orthosis (total 60 min)
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
Healthy person
Key exclusion criteria
a person who has bone and muscle disease, deformity, pain, or ROM limitaion
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Sairyo |
Organization
Tokushima University
Division name
Department of Orthopedics
Zip code
770-8503
Address
3-18-15, Kuramotocho, Tokushima-shi, Tokushima, 770-8503, Japan
TEL
088-633-7240
ksairyo@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Fujimoto |
| Middle name | |
| Last name | Yosuke |
Organization
Fujimoto P and O Supply Ltd.
Division name
Management Division
Zip code
770-0942
Address
3-31-3, Showacho, Tokushima-shi, Tokushima, 770-0942, Japan
TEL
088-652-6291
Homepage URL
y.fujimoto.po@gmail.com
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
University Hospital of Tokushima Clinical Trial Center for Developmental Therapeutics
Address
2-50-1, Kuramotocho, Tokushima-shi, Tokushima, 770-8503, Japan
Tel
088-633-9294
first-ec@tokushima-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
神戸医療福祉専門学校三田校（兵庫県）/Kobe College of Medical Welfare, Sanda Campus (Hyogo)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
10
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
| 2016 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 26 | Day |
Last modified on
| 2020 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026903
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
