UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056344 |
|---|---|
| Receipt number | R000064370 |
| Scientific Title | Development of a Computer-Assisted Training System Aimed at Improving Language and Motor Functions for Individuals with Congenital Genetic Disorders |
| Date of disclosure of the study information | 2024/12/03 |
| Last modified on | 2024/12/03 10:53:42 |
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Basic information
Public title
Computer-assisted training of speech and physical movement
Acronym
Patakara Plus
Scientific Title
Development of a Computer-Assisted Training System Aimed at Improving Language and Motor Functions for Individuals with Congenital Genetic Disorders
Scientific Title:Acronym
Patakara Plus
Region
| Japan |
Condition
Condition
congenial genetic disorders
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of a Computer-Assisted Training System Aimed at Improving Language and Motor Functions for Individuals with Congenital Genetic Disorders
Basic objectives2
Others
Basic objectives -Others
An Exploratory Study on Computer-Assisted Rehabilitation Methods
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Computer-Based Evaluation Metrics for Speech and Motor Functions
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
| Other |
Interventions/Control_1
Patakara Plus training
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants who meet both of the following criteria: 1) a diagnosis of a congenital genetic disorder. 2) the ability to perform necessary voice recordings and body movement video recordings.
Key exclusion criteria
Participants who do not meet any of the following criteria: 1) a diagnosis of a congenital genetic disorder. 2) the ability to perform necessary voice recordings and body movement video recordings.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Mishima |
Organization
Atomic Bomb Disease Institute, Nagasaki University
Division name
Department of Human Genetics, Genomic Function Analysis Unit
Zip code
852-8523
Address
1-12-4, Sakamoto, Nagasaki, Nagasaki, Japan
TEL
+81-95-819-7120
hmishima@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Mishima |
Organization
Atomic Bomb Disease Institute, Nagasaki University
Division name
Department of Human Genetics, Genomic Function Analysis Unit
Zip code
852-8523
Address
1-12-4, Sakamoto, Nagasaki, Nagasaki, Japan
TEL
+81-95-819-7120
Homepage URL
hmishima@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
The Kobayashi Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Administrarative Office, Nagasaki University Graduate School of Biomedical Sciences
Address
1-12-4, Sakamoto, Nagasaki, Nagasaki, Japan
Tel
095-819-7195
gakujutu_gakuji@ml.nagasaki-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 | 03 | 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 | 09 | Month | 13 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | 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
| 2024 | Year | 12 | Month | 03 | Day |
Last modified on
| 2024 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064370
