UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037356 |
|---|---|
| Receipt number | R000042593 |
| Scientific Title | The influence of observation of mouth shape on the synonym of aphasic person |
| Date of disclosure of the study information | 2019/07/13 |
| Last modified on | 2020/07/31 18:06:57 |
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Basic information
Public title
The influence of observation of mouth shape on the synonym of aphasic person
Acronym
The influence of observation of mouth shape on the synonym of aphasic person
Scientific Title
The influence of observation of mouth shape on the synonym of aphasic person
Scientific Title:Acronym
The influence of observation of mouth shape on the synonym of aphasic person
Region
| Japan |
Condition
Condition
Aphasic patients with cerebral lesions
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To check if observing the mouth form promotes the speech of the aphasia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The stage at which the correct answer was obtained in the naming task that gives cues in stages
Key secondary outcomes
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
60-words naming
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Aphasia patient in the range of correct answer rate 30-70% in "naming" of SLTA
Key exclusion criteria
Those who have severe aphasia and do not understand the task intention
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Towata |
| Middle name | |
| Last name | Takashi |
Organization
Tokai University Hospital
Division name
Rehabilitation Services Department
Zip code
259-1193
Address
143 Shimokasuya, Isehara-shi, Kanagawa
TEL
0463-93-1121
t-towata@tokai.ac.jp
Public contact
Name of contact person
| 1st name | Towata |
| Middle name | |
| Last name | Takashi |
Organization
Tokai University Hospital
Division name
Rehabilitation Services Department
Zip code
259-1193
Address
143 Shimokasuya, Isehara-shi, Kanagawa
TEL
0463-93-1121
Homepage URL
t-towata@tokai.ac.jp
Sponsor or person
Institute
Tokai University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokai University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokai University Hospital
Address
143 Shimokasuya, Isehara-shi, Kanagawa
Tel
0463-93-1121
t-towata@tokai.ac.jp
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
東海大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 13 | 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
| 2019 | Year | 04 | Month | 06 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 12 | Day |
Last modified on
| 2020 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042593
