UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022188 |
|---|---|
| Receipt number | R000025563 |
| Scientific Title | Clinimetric Properties of the Fugl-Meyer Assessment with Adapted Guidelines for the Assessment of Arm Function in Hemiparetic Patients after Stroke |
| Date of disclosure of the study information | 2016/05/03 |
| Last modified on | 2020/02/19 11:48:52 |
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Basic information
Public title
Clinimetric Properties of the Fugl-Meyer Assessment with Adapted Guidelines for the Assessment of Arm Function in Hemiparetic Patients after Stroke
Acronym
Clinimetric Properties of the Fugl-Meyer Assessment
Scientific Title
Clinimetric Properties of the Fugl-Meyer Assessment with Adapted Guidelines for the Assessment of Arm Function in Hemiparetic Patients after Stroke
Scientific Title:Acronym
Clinimetric Properties of the Fugl-Meyer Assessment
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 clinimetric properties (reliability, validity, and responsiveness) with adapted (Japanese) guidelines for the Fugl-Meyer Assessment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Scores of the Fugl-Meyer Assessment. Scores for each ordinally scaled item range from 0 to 2, scores for the test range from 0 to 66.
Key secondary outcomes
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 severe 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, Hyogo 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
Hospital of Hyogo College of Medicine
Division name
Department of physical medicine and rehabilitation
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo 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
TEIJIN PHARMA LIMITED
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
0798-45-6066
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）; Hospital of Hyogo College of Medicine
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 03 | 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 the non-simultaneous and simultaneous inter-rater reliability, ICC ranged from 0.809-0.983 (P<0.001) and 0.991-0.999 (P<0.001), respectively. Regarding the simultaneous intra-rater reliability, ICC ranged from 0.994-0.999 (P<0.001).
Results date posted
| 2020 | Year | 02 | Month | 19 | 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
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 03 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 03 | Day |
Date of closure to data entry
| 2019 | Year | 05 | Month | 23 | Day |
Date trial data considered complete
| 2019 | Year | 08 | Month | 07 | Day |
Date analysis concluded
| 2019 | Year | 10 | Month | 02 | Day |
Other
Other related information
Design: case-control study
Data collection/analysis will start in April 2016 and end in April 2020.
The present study includes a sample of convenience of patients hospitalized at the departments of rehabilitation in a university hospital in Japan speaking Japanese. Patients fulfilling inclusion criteria who agreed to participate will be included. The Action Research Arm Test (ARAT), Fugl-Meyer Assessment for upper extremity (FMA-UE) and Box and Block Test (BBT), Motor Activity Log (MAL) are employed.
The measurements are directly performed by the trained evaluators. Each task will be described and modeled by the trained therapists, and the patients are not allowed to practice the task.
For reliability and validity, two measurements will be performed with a 2-day interval for the patients with acute and sub-acute stroke (<180 days from onset). For the patients with chronic stroke (>=;180 days from onset), two measurements will be performed with a 7-day interval.
Management information
Registered date
| 2016 | Year | 05 | Month | 02 | Day |
Last modified on
| 2020 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025563
| Research Plan | |
|---|---|
| Registered date | File name |
| 2016/05/03 | 実施計画書(No. 2225).docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
