UMIN-CTR Clinical Trial

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
Email	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
Email	othswd@gmail.com

Sponsor
Institute	Yatsu Kyotaku Service Center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043688