UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038374 |
|---|---|
| Receipt number | R000043688 |
| Scientific Title | Reliability and Validity of Self-rating Scale for Upper Extremity after Stroke |
| Date of disclosure of the study information | 2019/10/24 |
| Last modified on | 2021/04/01 08:00:45 |
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Basic information
Public title
Reliability and Validity of Self-rating Scale for Upper Extremity after Stroke
Acronym
Development of Self-rating Scale for Upper Extremity for Stroke
Scientific Title
Reliability and Validity of Self-rating Scale for Upper Extremity after Stroke
Scientific Title:Acronym
Development of Self-rating Scale for Upper Extremity for Stroke
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Consider Reliability and Validity of Self-rating Scale for Upper Extremity after Stroke.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of upper extremity function(Fugl-Meyer Assessment)
Key secondary outcomes
Evaluation of upper extremity function(Motor Activity Log, Box and Block Test)
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) first stroke
2) more than 180 days after stroke onset
3) our day-care users with upper extremity after stroke
4) attend our day-care at least once a week
5) score of knee-mouth test and finger function test for Stroke Impairment Assessment Set 2-1b or more
6) gained consent to this research
Key exclusion criteria
1) dementia (Mini-Mental State Examination 23 points or less)
2) difficult of answer Self-rating Scale for Upper Extremity for Stroke with dementia, higher brain dysfunction and other
3) difficult of answer Motor Activity Log with dementia, higher brain dysfunction and other
4) cerebellar lesion
5) interrupt our day-care
6) judged inappropriate as this research for doctor
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiromi |
| Middle name | |
| Last name | Sawada |
Organization
Yatsu Kyotaku Service Center
Division name
Department of Rehabilitation
Zip code
275-0026
Address
2-23-11 Yatsu, Narashino-shi, Chiba
TEL
047-451-1700
othswd@gmail.com
Public contact
Name of contact person
| 1st name | Hiromi |
| Middle name | |
| Last name | Sawada |
Organization
Yatsu Kyotaku Service Center
Division name
Department of Rehabilitation
Zip code
275-0026
Address
2-23-11 Yatsu, Narashino-shi, Chiba
TEL
047-451-1700
Homepage URL
othswd@gmail.com
Sponsor or person
Institute
Yatsu Kyotaku Service Center
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethics committee of Tokyo Bay Rehabilitation Hospital
Address
4-1-1 Yatsu, Narashino-shi, Chiba
Tel
047-453-9000
shinsakai@wanreha.net
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
| 2019 | Year | 10 | Month | 24 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 01 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To assess the reliability and validity of Self-rating Scale for Upper Extremity after Stroke, the subjects answer to this scale every month for two months. Before or after one month from the test, we evaluate the upper extremity function.
Management information
Registered date
| 2019 | Year | 10 | Month | 24 | Day |
Last modified on
| 2021 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043688
