UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045772 |
|---|---|
| Receipt number | R000052256 |
| Scientific Title | Relationship between Performance and Inattention in Parkinson's Disease Patients: A Prospective Study. |
| Date of disclosure of the study information | 2021/10/16 |
| Last modified on | 2021/10/16 17:27:05 |
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Basic information
Public title
Relationship between Performance and Inattention in Parkinson's Disease Patients: A Prospective Study.
Acronym
Relationship between Performance and Inattention in Parkinson's Disease Patients: A Prospective Study.
Scientific Title
Relationship between Performance and Inattention in Parkinson's Disease Patients: A Prospective Study.
Scientific Title:Acronym
Relationship between Performance and Inattention in Parkinson's Disease Patients: A Prospective Study.
Region
| Japan |
Condition
Condition
Parkinson's Disease
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the back and forth relationship between Freezing Of Gait and center of gravity sway variables.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Basic Information
Physical Function Assessment
Center of Gravity Sway Index
Freezing Of Gait Evaluation
Psychological function assessment
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Of the Parkinson's disease patients who started visiting the hospital during the study period, those who answered "No" to the question "Have you ever experienced freezing of the gait? Patients who answered "No" to the question "Have you ever had swelling?
Those who have given consent for this study
Key exclusion criteria
Persons who require the assistance of others to measure the center of gravity sway bar
Persons who require the assistance of another person for gait function evaluation
Patients who have stage 5 or higher cognitive function tests (Functional Assessment Staging)
Those who were not able to complete the 12-month study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kichoru |
| Middle name | |
| Last name | Kin |
Organization
Kawaguchi Neurosurgery Rehabilitation Clinic
Division name
rehabilitation department
Zip code
5730086
Address
9-25-202, Kourien-cho, Hirakata-shi, Osaka
TEL
0728351010
kawaguchi.ns.reha@gmail.com
Public contact
Name of contact person
| 1st name | Kichoru |
| Middle name | |
| Last name | Kin |
Organization
Kawaguchi Neurosurgery Rehabilitation Clinic
Division name
rehabilitation department
Zip code
5730086
Address
9-25-202, Kourien-cho, Hirakata-shi, Osaka
TEL
0728351010
Homepage URL
kawaguchi.ns.reha@gmail.com
Sponsor or person
Institute
Kawaguchi Neurosurgery Rehabilitation Clinic
Institute
Department
Personal name
Funding Source
Organization
None
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
Kawaguchi Neurosurgery Rehabilitation Clinic
Address
9-25-202, Kourien-cho, Hirakata-shi, Osaka
Tel
0728351010
kawaguchi.ns.reha@gmail.com
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 | 10 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 10 | Month | 16 | Day |
Last modified on
| 2021 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052256
