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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030868
Receipt No. R000034561
Scientific Title effect of Constraint-Induced Aphasia Therapy (CIAT) for chronic aphasic patients inJapan
Date of disclosure of the study information 2018/01/19
Last modified on 2018/05/24

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Basic information
Public title effect of Constraint-Induced Aphasia Therapy (CIAT) for chronic aphasic patients inJapan
Acronym effect of CIAT for chronic aphasic patients in Japan
Scientific Title effect of Constraint-Induced Aphasia Therapy (CIAT) for chronic aphasic patients inJapan
Scientific Title:Acronym effect of CIAT for chronic aphasic patients in Japan
Region
Japan

Condition
Condition Stroke
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This therapy has not yet been reported in Japan; thus, we applied intensive CIAT training to our patients with chronic aphasia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Verbal Activity Log Score before and after training
Key secondary outcomes Standard Language test of aphasia and Western aphasia test score before and after training

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 We created a Japanese version of the CIAT-II protocol (Johnson et al., 2015) and applied it to each patient for 3 h/day for 15 consecutive weekdays. The applied CIAT therapy methods included intensive training by a behavioral method termed the Shaping and Transfer Package using five expressive language exercises.
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

Not applicable
Gender Male and Female
Key inclusion criteria It was diagnosed with aphasia.
It is recognized that speech is not used in Verbal Activity Log (amount of use score 3 or less).
chronic phase patients more than half a year after onset.
Patient agreed with the document.
Key exclusion criteria Untreated serious disease
Severe visual or hearing impairment,
Patients with aphasia due to traumatic brain injury or neurodegenerative disease.
Research participation was withdrawn by the patient himself and his / her family
It was judged by the doctor that continuation was difficult.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhisa Domen
Organization Hyogo College of Medicine
Division name Department of rehabilitation science
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya City, Hyogo Prefecture
TEL 0798-45-6111
Email office@craseed.org

Public contact
Name of contact person
1st name
Middle name
Last name Masaru Kanamori
Organization Hyogo College of Medicine College Hospital
Division name Department of physical medicine and rehabilitation
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya City, Hyogo Prefecture
TEL 0798-45-6111
Homepage URL
Email ma-kanamori@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization Hyogo College of Medicine
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
Email

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
2018 Year 01 Month 19 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 Open public recruiting
Date of protocol fixation
2016 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 01 Month 17 Day
Last modified on
2018 Year 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034561

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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