UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047573 |
|---|---|
| Receipt number | R000054181 |
| Scientific Title | A comparison of the gaps between capability ADL and performance ADL in the FIM instrument in the patients with stroke using an item response theory analysis |
| Date of disclosure of the study information | 2022/04/23 |
| Last modified on | 2023/12/11 23:55:05 |
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Basic information
Public title
A comparison of the gaps between capability ADL and performance ADL in the FIM instrument in the patients with stroke using an item response theory analysis
Acronym
A comparison of the gaps between capability ADL and performance ADL in the FIM instrument in the patients with stroke using an item response theory analysis
Scientific Title
A comparison of the gaps between capability ADL and performance ADL in the FIM instrument in the patients with stroke using an item response theory analysis
Scientific Title:Acronym
A comparison of the gaps between capability ADL and performance ADL in the FIM instrument in the patients with stroke using an item response theory analysis
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A comparison of the capability ADL being assessed by therapists and performance ADL being assessed by nurses in the FIM instrument in the patients with stroke
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Capability ADL and performance ADL in the Functional Independence Measure motor subscale on admission and discharge
Key secondary outcomes
1)Brunnstrom recovery stage
2)Functional Independence Measure cognitive
subscale
3)Length of hospital stay (days)
4)Discharge destination
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with stroke who admitted to our recovery rehabilitation ward from April 1, 2020 to March 31, 2022
Key exclusion criteria
(1)Patients transferred during hospitalization; (2)Patients with minimum and maximum scores on the FIM motor subscale (13 and 91 points); (3)Patients with lack of the FIM scores on admission and discharge; (4)Patients who refuse to participate in this study based on the optout.
Target sample size
132
Research contact person
Name of lead principal investigator
| 1st name | Rie |
| Middle name | |
| Last name | Sakamoto |
Organization
Hyogo College of Medicine Sasayama Medical Center
Division name
Department of Rehabilitation
Zip code
669-2321
Address
5 Kurooka, Tambasasayama, Hyogo 669-2321, Japan
TEL
079-552-7381
rie-saka@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Tauchi |
Organization
Hyogo College of Medicine Sasayama Medical Center
Division name
Department of Rehabilitation
Zip code
669-2321
Address
5 Kurooka, Tambasasayama, Hyogo 669-2321, Japan
TEL
079-552-7381
Homepage URL
tau24@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
not applicable
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 663-8501, Japan
Tel
0798-45-6111
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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 23 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2022 | Year | 11 | Month | 14 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 01 | Month | 02 | Day |
Other
Other related information
Study design: a single-center, retrospective, observational study
[Statistical analysis]
Ceiling and floor effects: item analysis (item difficulty and Polychoric correlation coefficient)
unidimensionality: Confirmatory Factor Analysis
Internal consistency: Cronbach's alpha and omega coefficient
Item-difficulty hierarchy: Item Response theory graded response model (Rasch)
Statistical software: R, JMP, HAD, exametrika, Mplus
Management information
Registered date
| 2022 | Year | 04 | Month | 23 | Day |
Last modified on
| 2023 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054181
