UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049947 |
|---|---|
| Receipt number | R000056887 |
| Scientific Title | Influence of spinal surgery for range of motion of the pelvis and lower limb |
| Date of disclosure of the study information | 2023/01/30 |
| Last modified on | 2022/12/31 16:49:52 |
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Basic information
Public title
Influence of spinal surgery for range of motion of the pelvis and lower limb
Acronym
Influence of spinal surgery for range of motion of the pelvis and lower limb
Scientific Title
Influence of spinal surgery for range of motion of the pelvis and lower limb
Scientific Title:Acronym
Influence of spinal surgery for range of motion of the pelvis and lower limb
Region
| Japan |
Condition
Condition
scoliosis, lumbar spinal canal stenosis, lumbar disc herniation
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This aim of this study is to evaluate the influence of spinal surgery for the range of motion of pelvis and lower limb
Basic objectives2
Others
Basic objectives -Others
Evaluation of the difference for the number of infusion
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
gait analysis
Key secondary outcomes
range of motion and exercise performance
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
non fusion group
Interventions/Control_2
fusion group without sacral fusion
Interventions/Control_3
fusion group with sacral fusion
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients who agree the research content
2.Patients who undergo spinal surgery
3.Patients who are able to keep standing by themselves.
Key exclusion criteria
1.Patients who have active mental disorder
2.Patients who have dementia
3.Patients who are unable to keep standing by themselves
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Taku |
| Middle name | |
| Last name | Ukai |
Organization
Tokai University
Division name
Department of orthopaedic surgery
Zip code
259-1193
Address
Shimokasuya 143, Isehara
TEL
0463-93-1121
taku115@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | Taku |
| Middle name | |
| Last name | Ukai |
Organization
Tokai University
Division name
Department of orthopaedic surgery
Zip code
259-1193
Address
Shimokasuya 143, Isehara
TEL
0463-93-1121
Homepage URL
taku115@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Funding Source
Organization
No funding
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokai University
Address
Shimokasuya 143, Isehara
Tel
0463-93-1121
taku115@is.icc.u-tokai.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
| 2023 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 01 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 31 | Day |
Last modified on
| 2022 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056887
| 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 |
