UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050868 |
|---|---|
| Receipt number | R000057973 |
| Scientific Title | Creation of a Japanese version of the Freezing of gait questionnaire and verification of its reliability and validity |
| Date of disclosure of the study information | 2023/04/17 |
| Last modified on | 2023/04/17 14:45:31 |
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Basic information
Public title
Creation of a Japanese version of the Freezing of gait questionnaire and verification of its reliability and validity
Acronym
Creation of a Japanese version of the Freezing of gait questionnaire and verification of its reliability and validity
Scientific Title
Creation of a Japanese version of the Freezing of gait questionnaire and verification of its reliability and validity
Scientific Title:Acronym
Creation of a Japanese version of the Freezing of gait questionnaire and verification of its reliability and validity
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a Japanese version of the FOGQ and verify its validity and reliability
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Freezing of Gait questionnaire
Key secondary outcomes
Fall Efficacy Scale
2-Step Test
Unified Parkinson's Disease Rating Scale
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
Parkinson's disease patient able to walk with a walking aid and perform a two-step test
Key exclusion criteria
Those who have difficulty understanding the research
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kicyoru |
| Middle name | |
| Last name | Kim |
Organization
Medical Corporation Kayoukai Kawaguchi Neurosurgery Rehabilitation Clinic
Division name
Department of Rehabilitation
Zip code
5730086
Address
9-25-202 Kourien-cho, Hirakata City, Osaka, Japan
TEL
0728351010
kawaguchi.ns.reha@gmail.com
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Iki |
Organization
Medical Corporation Kayoukai Kawaguchi Neurosurgery Rehabilitation Clinic
Division name
Department of Rehabilitation
Zip code
5730086
Address
9-25-202 Kourien-cho, Hirakata City, Osaka, Japan
TEL
0728351010
Homepage URL
kawaguchi.ns.reha@gmail.com
Sponsor or person
Institute
Medical Corporation Kayoukai Kawaguchi Neurosurgery Rehabilitation Clinic
Institute
Department
Personal name
Funding Source
Organization
Non
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
Medical Corporation Kayoukai Kawaguchi Neurosurgery Rehabilitation Clinic
Address
9-25-202 Kourien-cho, Hirakata City, Osaka, Japan
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
| 2023 | Year | 04 | Month | 17 | 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
| 2023 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 29 | 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
The FOGQ will be taken twice from Parkinson's disease patients within 2 weeks of study entry. Other questionnaires and measures of physical function will be measured only once within the first 2 weeks of the study. All questionnaires and measures of physical function will be administered outside of rehabilitation.
Management information
Registered date
| 2023 | Year | 04 | Month | 17 | Day |
Last modified on
| 2023 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057973
| Research Plan | |
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| 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 |
