UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049889 |
|---|---|
| Receipt number | R000055784 |
| Scientific Title | The validation of a Japanese version of the NFOG-Q. |
| Date of disclosure of the study information | 2022/12/24 |
| Last modified on | 2024/01/10 14:41:17 |
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Basic information
Public title
The validation of a Japanese version of the New Freezing of Gait Questionnaire (NFOG-Q).
Acronym
The validation of a Japanese version of the NFOG-Q.
Scientific Title
The validation of a Japanese version of the NFOG-Q.
Scientific Title:Acronym
The validation of a Japanese version of the NFOG-Q.
Region
| Japan | Asia(except Japan) |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
(1) Development of a Japanese version of NFOG-Q
To develop a Japanese version of the New Freezing of Gait Questionnaire (NFOG-Q), the widely used instrument for assessing the freezing of gait in PD, and to perform a cross-cultural adaptation of the NFOG-Q in Japanese.
(2) To investigate clinimetric properties (e.g., reliability, validity, and responsiveness) of a Japanese version of NFOG-Q.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Scores in a Japanese version of NFOG-Q.
Key secondary outcomes
Scores in MDS-UPDRS and Fall Efficacy Scale (FES). Time for the Timed Up and Go test (TUG).
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
| 40 | years-old | < |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) a clinical diagnosis of idiopathic PD according to MDS clinical diagnostic criteria.
2) Hoehn and Yahr stage of < 5 in the Off state.
3) a lack of clinically significant cognitive impairment.
Key exclusion criteria
Having other neurodegenerative diseases or orthopaedic problems negatively affect gait performance.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Seira |
| Middle name | |
| Last name | Taniguchi |
Organization
Osaka University
Division name
Graduate School of Medicine
Zip code
565-0871
Address
Yamadaoka 1-4, Suita, Osaka, Japan.
TEL
06-6879-5111
m-pas@umin.ac.jp
Public contact
Name of contact person
| 1st name | Seira |
| Middle name | |
| Last name | Taniguchi |
Organization
Osaka University
Division name
Graduate School of Medicine
Zip code
565-0871
Address
Yamadaoka 1-4, Suita, Osaka, Japan.
TEL
+(81)-6-6879-3571
Homepage URL
m-pas@umin.ac.jp
Sponsor or person
Institute
Department of Neurology, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research Japan society of the promotion of science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hyogo Prefectural Rehabilitation Center at Nishi-Harima
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board of Osaka University Hospital
Address
Center of Medical Innovation and Translational Research 4F, Yamadaoka 2-2, Suita, Osaka, Japan.
Tel
06-6210-8286
rinri@hp-crc.med.osaka-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
大阪大学医学部附属病院、兵庫県立リハビリテーション西播磨病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 24 | 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 | 11 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 11 | Month | 30 | Day |
Other
Other related information
Questionary investigation
Management information
Registered date
| 2022 | Year | 12 | Month | 23 | Day |
Last modified on
| 2024 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055784
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