UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043610 |
|---|---|
| Receipt number | 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 | 2023/12/11 23:39:14 |
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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
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
tau24@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
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
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
115
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
No longer 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
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 06 | Month | 28 | Day |
Date trial data considered complete
| 2023 | Year | 07 | Month | 04 | Day |
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 and Exploratory factor analysis
Internal consistency: Cronbach's alpha
Item-difficulty hierarchy: Item Response theory one parameter model
Statistical software: HAD, exametrika, Mplus, R
Management information
Registered date
| 2021 | Year | 03 | Month | 13 | Day |
Last modified on
| 2023 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.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 |
