UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049648 |
|---|---|
| Receipt number | R000056538 |
| Scientific Title | Japanese translation of Fugl-Meyer Assessment |
| Date of disclosure of the study information | 2023/12/01 |
| Last modified on | 2025/03/11 14:25:20 |
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Basic information
Public title
Validation of Fugl-Meyer assessment
Acronym
Validation of Fugl-Meyer assessment
Scientific Title
Japanese translation of Fugl-Meyer Assessment
Scientific Title:Acronym
Japanese translation of Fugl-Meyer Assessment
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The original Fugl-Meyer assessment ("FMA") has not been translated into Japanese and the Japanese version of the FMA shall be completed.
Basic objectives2
Others
Basic objectives -Others
The agreement of the Japanese FMA
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The Japanese version of the FMA will be evaluated in patients 180 days after the onset of cerebral infarction or hemorrhage. Two examiners will evaluate one patient on two separate days.
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with hemiplegia due to a first stroke or cerebral hemorrhage, 2) Patients with motor paralysis in the upper and lower limbs due to sequelae, 3) Patients more than 180 days after onset, 4) 18-90 years old
Key exclusion criteria
1) Patients with a score of less than 23 on the Mini Mental State Examination-Japanese, 2) Patients with amputation of any limb, 3) Patients with aphasia or psychiatric disorders that affect daily life, 4) Patients with severe joint pain that makes participation in the study difficult, 5) Patients with visual or hearing impairment, 6) Patients with serious terminal symptoms or uncontrolled medical conditions that would preclude their participation.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Nagao |
Organization
Kobe University Graduate School
Division name
Healt Science
Zip code
654-0142
Address
7-10-2, Tomogaoka, Suma ward, Kobe city
TEL
078-792-2555
nagao@kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukitaka |
| Middle name | |
| Last name | Tomdoa |
Organization
Kosei Hospital
Division name
Rehabilitation Department
Zip code
651-1505
Address
1788, Kusakabe, Doujo, Kita ward, Kobe sity
TEL
078-950-2622
Homepage URL
198k211k@stu.kobe-u.ac.jp
Sponsor or person
Institute
Kosei Hospital, Rehabilitation Department
Institute
Department
Personal name
Funding Source
Organization
Self
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
University of Gothenburg
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kosei Hospital
Address
1788, Kusakabe, Doujyou, Kita ward, Kobe city
Tel
0789502622
tomotomo19750423111@yahoo.co.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
恒生病院 （兵庫県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/index.cgi?function=02
Publication of results
Partially published
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_view.cgi?recptno=R000056538
Number of participants that the trial has enrolled
10
Results
In upper extremity coordination, tremor and dysmetria showed low reliability at 70%. Additionally, regarding leg and foot sensation in the lower limb, the responsiveness pattern (RP) exhibited a specific reaction.
Results date posted
| 2022 | Year | 11 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 02 | Month | 28 | Day |
Baseline Characteristics
ID Age Sex Stroke type Lesion side FMA-UE (0-66) FMA-LE (0-34) mRS MMSE-J
1 64 F CI Right 65 27 1 30
2 74 M CI Right 16 21 4 27
3 69 M CI Right 52 23 4 28
4 65 M CI Left 25 28 2 30
5 76 M CI Left 63 25 2 27
6 50 M ICH Right 59 21 2 30
7 60 F CI Left 61 28 2 30
8 59 F ICH Right 63 24 2 30
9 55 M CI Right 64 26 2 30
10 52 M ICH Right 16 20 3 30
Participant flow
A stroke patient who were 180 days post-onset.
Adverse events
nothing
Outcome measures
Results from the first and second Fugl-Meyer Assessments.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2024 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2024 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 06 | Month | 30 | Day |
Other
Other related information
Pilot study will be conducted using Japanese FMA.
Two evaluators will conduct two evaluations on one patient.
Management information
Registered date
| 2022 | Year | 11 | Month | 30 | Day |
Last modified on
| 2025 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056538
| Research Plan | |
|---|---|
| Registered date | File name |
| 2024/09/20 | 様式2 - 修正.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2024/09/20 | 研究症例データ仕様書.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2024/09/21 | 研究症例データ.csv |
Single case data URL
Value
https://center6.umin.ac.jp/ice/56538
