UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005562 |
|---|---|
| Receipt number | R000006589 |
| Scientific Title | Intervention study for the language development of hearing-impaired children. |
| Date of disclosure of the study information | 2011/05/06 |
| Last modified on | 2011/05/06 17:16:10 |
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Basic information
Public title
Intervention study for the language development of hearing-impaired children.
Acronym
Effect of domain-weighted language training for school-aged hearing impaired children
Scientific Title
Intervention study for the language development of hearing-impaired children.
Scientific Title:Acronym
Effect of domain-weighted language training for school-aged hearing impaired children
Region
| Japan |
Condition
Condition
Prelingual Hearing impairment
Language delay
Classification by specialty
| Pediatrics | Oto-rhino-laryngology | Rehabilitation medicine |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effectiveness of linguistically weighted training for the school-aged hearing-impaired children who demonstrated delay in their Japanese language acquisitions.Individually-adjusted language training with due consideration of the weakness in different elemental languages development was validated by this study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The JINN score (Japanese language developmental score with INtegration of Multiple domaiNs)
The score was calculated by averaging the adjusted standard deviation scores (z-scores) of perceptive/productive vocabulary and perceptive/productive syntax to evaluate age appropriate language development for school aged (6-12 years) children.
Key secondary outcomes
Each of language domains including perceptive and productive vocabulary, perceptive and productive syntax, pragmatic functions and discourse. Subjective rating from both their care-givers and trainers were also used by secondary objective values.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Individually-adjusted language training was conducted for 12 times in 6 months according to the prepared manual for this intervention program (LAMP program: Language-intended training with MultiPle-language domains)
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
| 6 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Hearing impaired children
1) those who aged 6-12 (school grade 1-6
2) those who have congenital hearing loss with 70dBHL or severer unaided hearing level at least at 4 years old.
3) those who demonstrated apparent delay in their language development by Assessment of LAnguage Development for Japanese chIldreN (ALADJIN)
Key exclusion criteria
The presence of additional handicaps other than hearing impairment.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kunihiro Fukushima |
Organization
Okayama University Postgraduate school of Medicine, Dentistry and Pharmaceutical Science
Division name
Department of Otolaryngology, Head & Neck Surgery
Zip code
Address
2-5-1 Shikata-cho Kita-ku Okayama
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norio Kasai |
Organization
Association of Technical Aids
Division name
Office for RSCD
Zip code
Address
TEL
086-239-2388
Homepage URL
senryakuchoukaku@kss.biglobe.ne.jp
Sponsor or person
Institute
Association of Technical Aids
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
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
| 2011 | Year | 05 | Month | 06 | 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
| 2011 | Year | 02 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 06 | Day |
Last modified on
| 2011 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006589
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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