UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037654 |
|---|---|
| Receipt number | R000042936 |
| Scientific Title | multicenter observational study investigating the relationship between worsening of forward flexion of trunk and deterioration of perceiving the vertical position in Parkinson disease patients |
| Date of disclosure of the study information | 2019/09/01 |
| Last modified on | 2024/09/26 18:11:05 |
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Basic information
Public title
multicenter observational study investigating the relationship between worsening of forward flexion of trunk and deterioration of perceiving the vertical position in Parkinson disease patients
Acronym
subjective vertical positions and forward flexion of trunk in Parkinson disease patients
Scientific Title
multicenter observational study investigating the relationship between worsening of forward flexion of trunk and deterioration of perceiving the vertical position in Parkinson disease patients
Scientific Title:Acronym
subjective vertical positions and forward flexion of trunk in Parkinson disease patients
Region
| Japan |
Condition
Condition
Parkinson disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to clarity the relationship between subjective vertical position and forward flexion of trunk
Basic objectives2
Others
Basic objectives -Others
Subjective vertical position allows prediction of posural deterioration
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
the correlation between forward flexion angle and subjective vertical position after 1 year
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
diagnosis of clinically established
MMSE above 24
consent to and paticipant
Key exclusion criteria
no predictable wearing off
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Makoto Shiraihsi |
| Middle name | |
| Last name | Shiraishi |
Organization
St. Marianan University School of Medicine
Division name
Neurology
Zip code
216-8511
Address
Miyamae
TEL
09095894465
shira@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Shiraishi |
Organization
St. Marianna University School of Medicine
Division name
Neurology
Zip code
216-8511
Address
Miyamae
TEL
09095894465
Homepage URL
shira@marianna-u.ac.jp
Sponsor or person
Institute
St.Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St.Marianna University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JP
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University Scool of Medicine
Address
2-16-1, Sugao, Miyamae, Kanagawa, Japan
Tel
09095894465
shira@marianna-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
| 2019 | 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
| 2019 | Year | 08 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
multicenter observational study
Management information
Registered date
| 2019 | Year | 08 | Month | 09 | Day |
Last modified on
| 2024 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042936
