UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056473 |
|---|---|
| Receipt number | R000064516 |
| Scientific Title | A study on voluntary movement training of articulatory organs at home |
| Date of disclosure of the study information | 2024/12/18 |
| Last modified on | 2024/12/17 12:06:23 |
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Basic information
Public title
A study on voluntary movement training of articulatory organs at home
Acronym
A study on voluntary movement training of articulatory organs at home
Scientific Title
A study on voluntary movement training of articulatory organs at home
Scientific Title:Acronym
A study on voluntary movement training of articulatory organs at home
Region
| Japan |
Condition
Condition
children with immature articulation
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1)An examination of the effects of training using lip and tongue voluntary movement training videos on the acquisition of articulation
2)Research on the use and utility of training videos
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)Performance of The Japanese Articulation Test (2nd)
2)Program satisfaction
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
1) Baseline evaluation
2) Video tranning program(approximately 3 times a week for a total of 6 sessions)
3) Reassessment
Interventions/Control_2
1) Baseline evaluation
2) Waiting
3) Reassessment
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
| 3 | years-old | <= |
Age-upper limit
| 7 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Young children in the 3-6 age range with immature articulation
Key exclusion criteria
1)Children with organic or functional diseases of the articulatory organs
2)Children with hearing impairment
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Tsujimura |
| Middle name | |
| Last name | Reona |
Organization
Health Sciences University of Hokkaido
Division name
School of Rehabilitation Sciences
Zip code
061-0293
Address
1757 Kanazawa Tobetsu-cho, Ishikari-gun, Hokkaido
TEL
0133-23-1211
reona@hoku-iryo-u.ac.jp
Public contact
Name of contact person
| 1st name | Tsujimura |
| Middle name | |
| Last name | Reona |
Organization
Health Sciences University of Hokkaido
Division name
School of Rehabilitation Sciences
Zip code
061-0293
Address
1757 Kanazawa Tobetsu-cho, Ishikari-gun, Hokkaido
TEL
0133-23-1211
Homepage URL
reona@hoku-iryo-u.ac.jp
Sponsor or person
Institute
Health Sciences University of Hokkaido
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Health Sciences University of Hokkaido
Address
1757 Kanazawa Tobetsu-cho, Ishikari-gun, Hokkaido
Tel
0133-23-1211
reona@hoku-iryo-u.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 18 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 17 | Day |
Last modified on
| 2024 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064516
