UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048612 |
|---|---|
| Receipt number | R000055169 |
| Scientific Title | Interpretability of the Fugl-Meyer Assessment Lower Extremity in Stroke Subjects: A Scoping Review |
| Date of disclosure of the study information | 2022/08/15 |
| Last modified on | 2025/03/06 22:58:02 |
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Basic information
Public title
Scoping Review for the Interpretability of the Fugl-Meyer Assessment Lower Extremity in Stroke Subjects
Acronym
Interpretability of the FMA Lower Extremity: A Scoping Review
Scientific Title
Interpretability of the Fugl-Meyer Assessment Lower Extremity in Stroke Subjects: A Scoping Review
Scientific Title:Acronym
Interpretability of the FMA Lower Extremity: A Scoping Review
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Neurology | Surgery in general | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aims of this review were: (1) to identify studies that investigated the interpretability of the Fugl-Meyer Assessment Lower Extremity.
Basic objectives2
Others
Basic objectives -Others
(2) to identify the statistical analysis used in these studies and the interpretability concept they targeted; and (3) to identify concrete values by summarizing the patient characteristics reported in the studies.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Fugl-Meyer Assessment Lower Extremity
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We searched three online databases: PubMed, CINAHL, and Web of Science. Search limits included peer-reviewed studies, published in English, by January 18, 2024. The commencing year limit was set for January 1, 1975.
The inclusion criterion for the present review was the study investigated the interpretability of the Fugl-Meyer Assessment Lower Extremity.
Key exclusion criteria
The exclusion criteria for our study are as follows: (1) no abstract, (2)duplicate articles, (3) languages other than English, (4) review articles, (5) conference proceedings, (6) Fugl-Meyer Assessment upper extremity only, (7) reports for subjects other than stroke, (8) implementation and scoring of the FMA-LE assessment by medical staff (ex., physical therapists or occupational therapists) experienced of stroke rehabilitation.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Tetsuharu |
| Middle name | |
| Last name | Nakazono |
Organization
Kitasato University Hospital
Division name
Department of Rehabilitation
Zip code
252-0375
Address
1-15-1, Kitasato, Minami-ku, Sagamihara-city, Japan
TEL
0427788413
ptnaka@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuharu |
| Middle name | |
| Last name | Nakazono |
Organization
Kitasato University Hospital
Division name
Department of Rehabilitation
Zip code
252-0375
Address
1-15-1,Kitasato,Minami-ku,Sagamihara,Japan
TEL
0427788413
Homepage URL
ptnaka@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University Hospital
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
Kitasato University Hospital
Address
1-15-1,Kitasato,Minami-ku,Sagamihara,Japan
Tel
0427788413
ptnaka@kitasato-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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 15 | 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
Main results already published
Date of protocol fixation
| 2022 | Year | 05 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The aims of this review were: (1) to identify studies that investigated the Fugl-Meyer Assessment Lower Extremity for stroke patients; (2) to identify the statistical analysis used in these studies and the interpretability concept they targeted; and (3) to identify concrete values by summarizing the patient characteristics reported in the studies.
Management information
Registered date
| 2022 | Year | 08 | Month | 06 | Day |
Last modified on
| 2025 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055169
