UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060940 |
|---|---|
| Receipt number | R000069737 |
| Scientific Title | An International Collaborative Study on the Development, Linguistic and Cultural Adaptation, and Standardization of the English Version of the Screening Test for Aphasia and Dysarthria (STAD) |
| Date of disclosure of the study information | 2026/03/16 |
| Last modified on | 2026/03/15 14:48:33 |
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Basic information
Public title
International Collaborative Development and Standardization of the English Version of STAD (Screening Test for Aphasia and Dysarthria)
Acronym
English STAD Study
Scientific Title
An International Collaborative Study on the Development, Linguistic and Cultural Adaptation, and Standardization of the English Version of the Screening Test for Aphasia and Dysarthria (STAD)
Scientific Title:Acronym
STAD-English Standardization Study
Region
| Japan | North America | South America |
| Europe |
Condition
Condition
Post-brain injury communication disorders, including aphasia, dysarthria, and communication disorders associated with higher brain dysfunction
Classification by specialty
| Neurology | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to develop an English version of the Screening Test for Aphasia and Dysarthria (STAD), a brief screening tool for communication disorders after brain injury, and to promote its standardization following linguistic and cultural adaptation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Phase I
Assessment
Primary outcomes
Total score of the English version of STAD, measured at a single assessment in English-speaking participants using the finalized version after linguistic and cultural adaptation
Key secondary outcomes
1.Scores for each subitem of the English version of STAD, measured at a single assessment in English-speaking participants and patients
2.Administration time of the English version of STAD, measured during a single assessment
3.Participant feedback on comprehensibility and ease of response after administration of the English version of STAD, collected immediately after the assessment
4.Number and content of items judged to require linguistic and cultural modification, evaluated after each assessment
5.Internal consistency, inter-rater reliability, test-retest reliability, and validity based on associations with established standard assessments of the English version of STAD, evaluated using patient data
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Individuals who provide written informed consent to participate in the study
2.Adults whose primary language is English
3.For the healthy control group, individuals without an apparent history of brain injury, neurological disease, psychiatric disorder, or severe visual or hearing impairment
4.For the patient group, individuals judged to have aphasia, dysarthria, or communication disorders associated with higher brain dysfunction after brain injury
5.Individuals with an adequate level of consciousness and general condition to undergo the assessment
Key exclusion criteria
1.Individuals with severe disturbance of consciousness or poor general condition that makes assessment difficult
2.Individuals with severe visual, hearing, or motor impairment that makes assessment difficult
3.Individuals judged by the principal investigator or subinvestigators to be inappropriate for participation in this study
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Araki |
Organization
International University of Health and Welfare, Narita Hospital
Division name
Department of Rehabilitation Technology
Zip code
286-8520
Address
852 Hatagata, Narita, Chiba 286-8520, Japan
TEL
0476-35-5600
kentaro-araki@ihwg.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Araki |
Organization
International Medical Welfare University Narita Hospital
Division name
Department of Rehabilitation Technology
Zip code
286-8520
Address
852 Hatagata, Narita, Chiba
TEL
0476-35-5639
Homepage URL
https://kentaro-a-lucky.jimdofree.com/
kentaro-araki@ihwg.jp
Sponsor or person
Institute
International University of Health and Welfare, Narita Hospital, Department of Rehabilitation Technology, Kentaro Araki, SLP, PhD
Institute
Department
Personal name
Kentaro Araki
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS) KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International Medical Welfare University
Address
852 Hatagata, Narita, Chiba 286-8520, Japan
Tel
0476-35-5639
kentaro-araki@ihwg.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 16 | Day |
Related information
URL releasing protocol
https://kentaro-a-lucky.jimdofree.com/
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
Preinitiation
Date of protocol fixation
| 2025 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is an observational study and does not involve any intervention. The English version of STAD will be administered once to healthy English-speaking participants and to patients with post-brain injury communication disorders. Data to be collected include STAD scores, administration time, and participant feedback on comprehensibility and ease of response. In addition, reliability and validity of the English version of STAD will be examined using patient data. Linguistic and cultural modifications will also be considered as needed based on the assessment results and participant feedback.
Management information
Registered date
| 2026 | Year | 03 | Month | 15 | Day |
Last modified on
| 2026 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069737
