UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of the Screening Test for Aphasia and Dysarthria
Title of the study (Brief title)	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	Eiji Shimizu
Organization	Chiba University Graduate School of Medicine
Division name	Department of Cognitive Behavioral Physiology Director Research Center for Child Mental Development
Address	1-8-1 Inohana, Chuouku, Chiba 260-8670 JAPAN
TEL	043-226-2027
Email	eiji@faculty.chiba-u.jp

Public contact
Name of contact person	Daisuke Matsuzawa
Organization	Chiba University Graduate School of Medicine
Division name	Department of Cognitive Behavioral Physiology
Address	1-8-1 Inohana, Chuouku, Chiba 260-8670 JAPAN
TEL	043-226-2027
Homepage URL
Email	dmatsuzawa@faculty.chiba-u.jp

Sponsor
Institute	Mitsuwadai General Hospital
Institute
Department

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2013 Year 12 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016348