UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034170 |
|---|---|
| Receipt number | 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 | 2020/02/24 13:33:53 |
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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
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
satoru@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
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
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
Regarding inter-rater reliability, the intraclass correlation coefficient was 0.994 (95% confidence interval: 0.988 to 0.997; P < .001). The mean differences between the raters of the shortened FMA were 0.07, and the limits of agreement were calculated to be between -0.81 and 0.95.
Results date posted
| 2020 | Year | 02 | Month | 24 | Day |
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
| 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
| 2020 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038261
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