UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014040 |
|---|---|
| Receipt number | R000016348 |
| Scientific Title | Development of the Screening Test for Aphasia and Dysarthria |
| Date of disclosure of the study information | 2014/05/24 |
| Last modified on | 2017/05/24 16:47:17 |
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Basic information
Public title
Development of the Screening Test for Aphasia and Dysarthria
Acronym
Development of the Screening Test for Aphasia and Dysarthria
Scientific Title
Development of the Screening Test for Aphasia and Dysarthria
Scientific Title:Acronym
Development of the Screening Test for Aphasia and Dysarthria
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Neurology | Vascular surgery | Neurosurgery |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the accuracy of the new Screening Test for Aphasia and Dysarthria (STAD).
Basic objectives2
Others
Basic objectives -Others
Development of the Screening Test
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Interrater reliability, diagnostic validity, and convergent/discriminant validity.
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 120 | years-old | > |
Gender
Male and Female
Key inclusion criteria
A total of 70 patients prescribed for speech and language rehabilitation.
Key exclusion criteria
Patients will be excluded if they had any of the following characteristics (1) deafness or blindness (2) nonnative Japanese language (3) altered consciousness
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Shimizu |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Cognitive Behavioral Physiology Director Research Center for Child Mental Development
Zip code
Address
1-8-1 Inohana, Chuouku, Chiba 260-8670 JAPAN
TEL
043-226-2027
eiji@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Matsuzawa |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Cognitive Behavioral Physiology
Zip code
Address
1-8-1 Inohana, Chuouku, Chiba 260-8670 JAPAN
TEL
043-226-2027
Homepage URL
dmatsuzawa@faculty.chiba-u.jp
Sponsor or person
Institute
Mitsuwadai General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 12 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Via the videotape, 12 SLPs will record the patients' responses on their own assessment sheets without knowledge of the others' entries.
The diagnostic accuracy and convergent/discriminant validity of each STAD section will be determined by comparing the section-scores of the patients with the clinical diagnoses obtained retrospectively by the SLPs.
Management information
Registered date
| 2014 | Year | 05 | Month | 22 | Day |
Last modified on
| 2017 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016348
