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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043688


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name