UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030868 |
|---|---|
| Receipt number | 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 | 2020/05/21 08:25:55 |
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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
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
ma-kanamori@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 10 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 20 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 17 | Day |
Last modified on
| 2020 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.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 | |
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| Registered date | File name |
