UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002198 |
|---|---|
| Receipt number | R000002703 |
| Scientific Title | A retrospective study on aphasia therapy |
| Date of disclosure of the study information | 2009/07/15 |
| Last modified on | 2011/08/16 10:55:03 |
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Basic information
Public title
A retrospective study on aphasia therapy
Acronym
A retrospective study on aphasia therapy
Scientific Title
A retrospective study on aphasia therapy
Scientific Title:Acronym
A retrospective study on aphasia therapy
Region
| Japan |
Condition
Condition
Cerebrovascular disease
Traumatic brain injury
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate short-term,mid-term and long-term aphasia therapy effects in language functions,communications skills and social participation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Standard Language Test of Aphasia
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with aphasia due to cerebral damages
Key exclusion criteria
1.Patients with plural attacks
2.Patients with serious physical complications
3.Patients with two or more focuses
4.Patients with severe dementia
5.Left-handed or ambidexterity patients
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Tanemura |
Organization
Kawasaki University of Medical Welfare
Division name
Faculty of Health Science and Technology Department of Sensory Science
Zip code
Address
288 Matushima Kurashiki-city Okayama-prefecture
TEL
086-462-1111(54631)
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Tanemura |
Organization
Kawasaki University of Medical Welfare
Division name
Faculty of Health Science and Technology Department of Sensory Science
Zip code
Address
288 Matushima Kurashiki-city Okayama-prefecture
TEL
086-462-1111(54631)
Homepage URL
tanemura@mw.kawasaki-m.ac.jp
Sponsor or person
Institute
Japan Society for Higher Brain Dysfunction
Institute
Department
Personal name
Funding Source
Organization
Japan Society for Higher Brain Dysfunction
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Showa University
Mejiro University
Edogawa Hospital
Name of secondary funder(s)
None
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
| 2009 | Year | 07 | Month | 15 | 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
| 2009 | Year | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1.Patients characteristics
1)sex, age
2)etiology
3)paralysis of limbs
4)hemianopia
5)focuses in cerebral hemispheres
6)dominant hand
7)schooling history
8)date of onset
9)age of onset
10)time of intervention(months from onset)
11)duration of intervention(months until final evaluation
2.Evaluation
1)type of aphasia
2)time when administered the Standard Language Test of Aphasia(months from onset)
3)severity of aphasia
4)frequency of therapies
5)forms of therapies
6)purposes of therapies
7)results of the Standard Language Test of Aphasia
Management information
Registered date
| 2009 | Year | 07 | Month | 14 | Day |
Last modified on
| 2011 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002703
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
