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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000005562
Receipt No. 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

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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
Email

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
Email senryakuchoukaku@kss.biglobe.ne.jp

Sponsor
Institute Association of Technical Aids
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006589

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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