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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034170
Receipt No. R000038261
Scientific Title Clinimetric Properties of the Shortened Fugl-Meyer Assessment for the Assessment of Arm Function in Hemiparetic Patients after Stroke: A Retrospective Study
Date of disclosure of the study information 2018/10/01
Last modified on 2019/09/17

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Basic information
Public title Clinimetric Properties of the Shortened Fugl-Meyer Assessment for the Assessment of Arm Function in Hemiparetic Patients after Stroke: A Retrospective Study
Acronym Clinimetric Properties of the Shortened Fugl-Meyer Assessment for the Arm Function
Scientific Title Clinimetric Properties of the Shortened Fugl-Meyer Assessment for the Assessment of Arm Function in Hemiparetic Patients after Stroke: A Retrospective Study
Scientific Title:Acronym Clinimetric Properties of the Shortened Fugl-Meyer Assessment for the Arm Function
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 asses s its clinimetric properties with adapted (Japanese) guidelines for the shortened Fugl-Meyer Assessment (FMA).
Basic objectives2 Others
Basic objectives -Others # We aimed to examine the extent to which the shortened FMA (6-item FMA) expresses the original FMA (33-item FMA).

# We also aimed to examine the appropriateness of the shortening process.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The shortened Fugl-Meyer Assessment (6-item FMA)
Key secondary outcomes The Fugl-Meyer Assessment (33-item FMA), the Action Research Arm Test, the Box and Block Test, and the Motor Activity Log.

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) clear sign of dementia; (2) mental disorder, or aphasia as an obstacle to daily living; (3) excessive pain; (4) the sever e end-stage or uncontrolled medical conditions.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Kazuhisa
Middle name
Last name Domen
Organization Hyogo College of Medicine
Division name Department of Rehabilitation Medicine
Zip code 663-8501
Address 1-1 Mukogawa-cho, Nishinomiya, Hyog o 663-8501, Japan
TEL 0798-45-6644
Email office@craseed.org

Public contact
Name of contact person
1st name Satoru
Middle name
Last name Amano
Organization Hyogo College of Medicine
Division name Department of physical medicine and rehabilitation
Zip code 663-8501
Address 1-1 Mukogawa-cho, Nishinomiya, Hyog o 663-8501, Japan
TEL 0798-45-6388
Homepage URL
Email satoru@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization None.
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 66 3-8501, Japan
Tel 0798-45-6066
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 兵庫医科大学病院(兵庫県); Hyogo College of Medicine College Hospital

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 01 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 30
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
2018 Year 09 Month 01 Day
Date of IRB
2018 Year 09 Month 01 Day
Anticipated trial start date
2018 Year 10 Month 02 Day
Last follow-up date
2019 Year 10 Month 31 Day
Date of closure to data entry
2019 Year 10 Month 31 Day
Date trial data considered complete
2019 Year 12 Month 31 Day
Date analysis concluded
2020 Year 01 Month 15 Day

Other
Other related information Design: A retrospective cross-sectional single-center study

This study involves retrospective reviews of 30 patients who were recruited between June 2016 and March 2017 in the Hyogo College of Medicine College Hospital.

(Statistical analysis)
Group comparison: Wilcoxon singed rank test
Inter-rater reliability of the sum scores: Intraclass correlation coefficient
Inter-rater reliability of the individual item scores: weighted kappa
Inter-rater agreement of the sum scores: Bland-Altman plot, Limits of agreement
Validity: Spearman's rank-order correlation coefficient
Internal consistency: Cronbach's alpha
Item difficulty: Rasch model (Item Response Theory, one parameter model)
Appropriateness of shortening method: Infit/outfit statistics, Cronbach's alpha, Corrected item-total correlation

Statistical software: SPSS, JMP, R

Primary outcome: 6-item Fugl-Meyer Assessment
Secondary outcomes: 33-item Fugl-Meyer Assessment, Action Research Arm Test, Box-and-Block Test, Motor Activity Log

Management information
Registered date
2018 Year 09 Month 16 Day
Last modified on
2019 Year 09 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038261

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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