UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033496 |
|---|---|
| Receipt number | R000038198 |
| Scientific Title | Reliability and Validity of Japanese Version of the Revised Upper Limb Module in Spinal Muscular Atrophy |
| Date of disclosure of the study information | 2018/08/25 |
| Last modified on | 2021/01/27 13:28:51 |
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Basic information
Public title
Reliability and Validity of Japanese Version of the Revised Upper Limb Module in Spinal Muscular Atrophy
Acronym
Reliability and Validity of Japanese Version of the Revised Upper Limb Module
Scientific Title
Reliability and Validity of Japanese Version of the Revised Upper Limb Module in Spinal Muscular Atrophy
Scientific Title:Acronym
Reliability and Validity of Japanese Version of the Revised Upper Limb Module
Region
| Japan |
Condition
Condition
Spinal Muscular Atrophy
Classification by specialty
| Pediatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to assess the reliability and validity of the Japanese version of the Revised Upper Limb Module.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the Japanese version of the Revised Upper Limb Module
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 2 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with spinal muscular atrophy type 2 and 3
Informed consent to participate to the study is obtained from the parents
age 2.5 years-
Key exclusion criteria
Patients need tracheotomy or the mechanical ventilators for 24 hours
Patients judged by the investigators to be inappropriate as study subjects
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ikai Tetsuo |
Organization
Tokyo Women's Medical University
Division name
Department of Rehabilitation Medicine
Zip code
Address
8-1, Kawadacho, Shinjyuku-ku, Tokyo, Japan
TEL
03-3353-8111
ikai.tetsuo@twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Uchio Yuu |
Organization
Tokyo Women's Medical University
Division name
Department of Rehabilitation
Zip code
Address
8-1, Kawadacho, Shinjyuku-ku, Tokyo, Japan
TEL
03-3353-8111
Homepage URL
uchio.yu@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University
Organization
Division
Category of Funding Organization
Self funding
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
| 2018 | Year | 08 | Month | 25 | 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
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is to assess the reliability and validity of the Japanese version of the Revised Upper Limb Module.
Management information
Registered date
| 2018 | Year | 07 | Month | 24 | Day |
Last modified on
| 2021 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038198
