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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043610
Receipt No. R000049785
Scientific Title Dimensionality and item-difficulty hierarchy of the Simple Test Evaluation Function(STEF)
Date of disclosure of the study information 2021/03/14
Last modified on 2021/03/13

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Basic information
Public title Dimensionality and item-difficulty hierarchy of the Simple Test Evaluation Function(STEF)
Acronym Psychometric properties of the Simple Test Evaluation Function(STEF)
Scientific Title Dimensionality and item-difficulty hierarchy of the Simple Test Evaluation Function(STEF)
Scientific Title:Acronym Psychometric properties of the Simple Test Evaluation Function(STEF)
Region
Japan

Condition
Condition Stroke
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to clarify the dimensionality and item-difficulty hierarchy of the Simple Test Evaluation Function for stroke rehabilitation in Japanese patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Simple Test Evaluation Function(STEF)
Key secondary outcomes Brunnstrom recovery stage(Upper extremity, Hand)
Stroke Impairment Assessment Set(Sensory of the upper extremity)
modified Rankin Scale Japanese version

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
100 years-old >=
Gender Male and Female
Key inclusion criteria Patients with first time unilateral supratentorial stroke
Key exclusion criteria Exclusion criteria were as follows:(1) patients with the cerebellum and brainstem stroke ,significant pain and stiffness in the more affected upper extremity, (2) severe sensory of upper extremity, (3) severe cognitive deficits that would preclude clinical evaluations, and (4) other severe medical conditions.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Rie
Middle name
Last name Sakamoto
Organization Hyogo College of Medicine Sasayama Medical Center
Division name Department of Rehabilitation
Zip code 669-2321
Address 5 Kurooka, Tanbasasayama, Hyogo 669-2321, Japan
TEL 079-552-7381
Email rie-saka@hyo-med.ac.jp

Public contact
Name of contact person
1st name Yuta
Middle name
Last name Tauchi
Organization Hyogo College of Medicine Sasayama Medical Center
Division name Department of Rehabilitation
Zip code 669-2321
Address 5 Kurooka, Tanbasasayama, Hyogo 669-2321, Japan
TEL 079-552-7381
Homepage URL
Email tau24@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization not applicable
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hyogo College of Medicine
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501, Japan
Tel 0798-45-6111
Email rinri@hyo-med.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
2021 Year 03 Month 14 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 Open public recruiting
Date of protocol fixation
2019 Year 08 Month 04 Day
Date of IRB
2019 Year 08 Month 16 Day
Anticipated trial start date
2019 Year 08 Month 16 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study Design: Multicenter prospective observational study

[Statistical analysis]
Ceiling and floor effects: item analysis (item difficulty and Pearson product-moment correlation coefficient)
Dimensionality: Confirmatory Factor Analysis
Internal consistency: Cronbach's alpha
Item-difficulty hierarchy: Item Response theory one parameter model

Statistical software: HAD, exametrika, Mplus


Management information
Registered date
2021 Year 03 Month 13 Day
Last modified on
2021 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049785

Research Plan
Registered date File name
2021/09/14 簡易上肢機能検査(Simple Test Evaluation Function:STEF)の次元性と項目難易度ver3.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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