UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030366 |
|---|---|
| Receipt number | 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 | 2023/08/02 19:01:52 |
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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
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
takshi77@rehab.osakafu-u.ac.jp
Sponsor or person
Institute
Osaka Prefecture University
Institute
Department
Personal name
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
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
Completed
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 | 31 | 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
| 2023 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034660
