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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030366
Receipt No. R000034660
Scientific Title Construct Validity , Rank and Item analysis of the Fugl-Meyer Assessment of the Upper Extremity
Date of disclosure of the study information 2017/12/12
Last modified on 2020/04/26

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Basic information
Public title Construct Validity , Rank and Item analysis of the Fugl-Meyer Assessment of the Upper Extremity
Acronym Measurement properties of Fugl-Meyer Assessment of the Upper Extremity
Scientific Title Construct Validity , Rank and Item analysis of the Fugl-Meyer Assessment of the Upper Extremity
Scientific Title:Acronym Measurement properties of Fugl-Meyer Assessment of the Upper Extremity
Region
Japan

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

Objectives
Narrative objectives1 The aim of the present study is to assess its Measurement properties (construct validity, rank and item analysis) for the Fugl-Meyer Assessment of the Upper Extremity.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Item Scores of the Fugl-Meyer Assessment of the Upper Extremity. Scores for each ordinally scaled 33 item range from 0 to 2.
Key secondary outcomes

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 (incomplete) upper extremity paresis resulting from stroke are included
Key exclusion criteria Exclusion criteria include the following:(1)Patients who can not understand instructions for examination;(2)Coexisting diseases that can not be controlled with the risk of accidents during evaluation and subjects at terminal stage.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Takebayashi
Organization Osaka Prefecture University, Osaka
Division name Department of Occupation therapy
Zip code 583-8555
Address 3-7-30, Habikino, Habikino, Osaka, Japan
TEL 072-950-2111
Email takshi77@rehab.osakafu-u.ac.jp

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Takebayashi
Organization Osaka Prefecture University, Osaka
Division name Department of Occupation therapy
Zip code 583-8555
Address 3-7-30, Habikino, Habikino, Osaka, Japan
TEL 072-950-2111
Homepage URL
Email takshi77@rehab.osakafu-u.ac.jp

Sponsor
Institute Osaka Prefecture University
Institute
Department

Funding Source
Organization Osaka Prefecture University
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 Kibi International University
Address 8, Igamachi, Takahashi, Okayama, Japan
Tel 0866-22-9454
Email takshi77@rehab.osakafu-u.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 大阪府立大学(大阪府);Osaka Prefecture University

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 12 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
2017 Year 04 Month 01 Day
Date of IRB
2017 Year 04 Month 17 Day
Anticipated trial start date
2017 Year 04 Month 17 Day
Last follow-up date
2022 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Design:Secondary analysis of Cross-sectional study

Data collection/analysis will start in April 2017 and end in April 2022.

Management information
Registered date
2017 Year 12 Month 12 Day
Last modified on
2020 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034660

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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