UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052135 |
|---|---|
| Receipt number | R000059475 |
| Scientific Title | Validity and reliability of the Japanese version of the Freezing of gait questionnaire for patients with Parkinson disease |
| Date of disclosure of the study information | 2023/09/07 |
| Last modified on | 2024/11/19 10:13:48 |
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Basic information
Public title
Validity and reliability of the Japanese version of the Freezing of gait questionnaire for patients with Parkinson disease
Acronym
Validity and reliability of the Japanese version of the Freezing of gait questionnaire for patients with Parkinson disease
Scientific Title
Validity and reliability of the Japanese version of the Freezing of gait questionnaire for patients with Parkinson disease
Scientific Title:Acronym
Validity and reliability of the Japanese version of the Freezing of gait questionnaire for patients with Parkinson disease
Region
| Japan |
Condition
Condition
Parkinson disease
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to validate the validity and reliability of the Japanese version of the Freezing of gait questionnaire and to identify physical functional characteristics associated with freezing of gait in patients with Parkinson disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Freezing of gait questionnaire
Key secondary outcomes
Unified Parkinson's Disease Rating Scale
2 step test
Fall efficacy 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
| 60 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Parkinson disease
> 60 age
Able to walk
Key exclusion criteria
Dementia
No diagnosis of fracture
Target sample size
158
Research contact person
Name of lead principal investigator
| 1st name | Katsuya |
| Middle name | |
| Last name | Sakai |
Organization
Tokyo Metropolitan University
Division name
Faculty of Health Sciences
Zip code
116-8551
Address
7-2-10, Higashiogu, Arakawa-ku, Tokyo
TEL
03-3819-1211
k.sakai@tmu.ac.jp
Public contact
Name of contact person
| 1st name | Katsuya |
| Middle name | |
| Last name | Sakai |
Organization
Tokyo Metropolitan University
Division name
Faculty of Health Sciences
Zip code
116-8551
Address
7-2-10, Higashiogu, Arakawa-ku, Tokyo
TEL
03-3819-1211
Homepage URL
k.sakai@tmu.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Daiwa Securities
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
PDit
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba Prefectural University of Health Sciences
Address
645-1, Nitonacho, Chuo-ku, Chiba city
Tel
043-305-2164
k.sakai@tmu.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
PDit
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 07 | 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
| 2022 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-sectional study
Management information
Registered date
| 2023 | Year | 09 | Month | 07 | Day |
Last modified on
| 2024 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059475
