UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061592 |
|---|---|
| Receipt number | R000068176 |
| Scientific Title | Translation into Japanese and Examination of the Reliability and Validity of the Drinking Task Assessment |
| Date of disclosure of the study information | 2026/08/01 |
| Last modified on | 2026/05/15 23:22:32 |
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Basic information
Public title
Translation into Japanese and Examination of the Reliability and Validity of the Drinking Task Assessment
Acronym
Translation into Japanese and Examination of the Reliability and Validity of the Drinking Task Assessment
Scientific Title
Translation into Japanese and Examination of the Reliability and Validity of the Drinking Task Assessment
Scientific Title:Acronym
Translation into Japanese and Examination of the Reliability and Validity of the Drinking Task Assessment
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A culturally validated Japanese version of the Drinking Task Assessment (DTA) has not yet been developed, limiting its implementation in clinical settings in Japan. This study aims to develop a Japanese version of the DTA that maintains the conceptual integrity of the original while ensuring cultural appropriateness and semantic equivalence. Furthermore, by examining its reliability and validity, the study seeks to contribute to the standardization of upper limb function assessment and the advancement of physical therapy practice.
Basic objectives2
Others
Basic objectives -Others
The reliability and validity of DTA
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
DTA
Key secondary outcomes
Fugl-Meyer Assessment-UE (FMA-UE), Mini Mental State Examination- Japanese
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
| 18 | years-old | < |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants will be:Patients with first ever stroke sequelae,Aged between 18 and 90 years, At least 30 days post onset, Patients with hemiparesis, Patients with a Fugl Meyer Assessment of the Upper Extremity score of less than 66
Key exclusion criteria
The exclusion criteria are as follows:
Patients who are unable to follow the instructions necessary for the assessment
Patients with other upper limb disorders that may affect upper limb motor performance
Patients who are unable to perform the tasks even with visual correction such as glasses or contact lenses
Patients with a Mini-Mental State Examination Japanese (MMSE J) score of less than 20
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Nagao |
Organization
Graduate School of Health Sciences, Kobe University
Division name
Department of Motor Function Disorder Science
Zip code
654-0142
Address
7-10-2 Tomogaoka, Suma-ku, Kobe, Hyogo, Japan
TEL
078-792-2555
nagao@kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoda |
| Middle name | |
| Last name | Yukitaka |
Organization
Graduate School of Health Sciences, Kobe University
Division name
Department of Motor Function Disorder Science
Zip code
6570061
Address
1788, kusakabe, Doujyou, Kita ward, Kobe, Japan
TEL
0789502622
Homepage URL
198k211k@gsuite.kobe-u.ac.jp
Sponsor or person
Institute
Kosei Hospital
Institute
Department
Personal name
Yukitaka Tomoda
Funding Source
Organization
In the process of applying for Japanese Physical Therapy Association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Gothenburg University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kose Hospiatal
Address
1788, Kusakabe, Doujyou, Kita ward, Kobe city
Tel
0789502622
198k211k@gsuite.kobe-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
恒生病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | 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
30
Results
DTA
Results date posted
| 2025 | Year | 10 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The purpose of this study is to develop a Japanese version of the Drinking Task Assessment (DTA) for patients with post-stroke sequelae.
The study will be conducted at Kosei Hospital from December 2025 to May 2027.
Participants will include ten patients with post-stroke sequelae who are hospitalized at the study site.
Participant flow
patients who are more than 30 days post-stroke onset
Adverse events
Outcome measures
FMA-LE MMSE-J
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2025 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 05 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 12 | Month | 31 | Day |
Other
Other related information
A pilot study will be conducted using the Japanese version of the Fugl-Meyer Assessment (FMA).
Two evaluators will each assess one patient twice.
Subsequently, the reliability and validity of the assessment will be examined.
Management information
Registered date
| 2026 | Year | 05 | Month | 15 | Day |
Last modified on
| 2026 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068176
