UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060406 |
|---|---|
| Receipt number | R000068997 |
| Scientific Title | Structural Validity of the Functional Assessment for Control of Trunk (FACT) in Patients After Subacute Stroke: A Rasch Analysis |
| Date of disclosure of the study information | 2026/01/20 |
| Last modified on | 2026/01/20 12:23:02 |
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Basic information
Public title
Structural Validity of the Functional Assessment for Control of Trunk (FACT) in Patients After Subacute Stroke: A Rasch Analysis
Acronym
Structural Validity of the Functional Assessment for Control of Trunk (FACT) in Patients After Subacute Stroke: A Rasch Analysis
Scientific Title
Structural Validity of the Functional Assessment for Control of Trunk (FACT) in Patients After Subacute Stroke: A Rasch Analysis
Scientific Title:Acronym
Structural Validity of the FACT in Patients After Subacute Stroke: Rasch Analysis
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify the structural validity and reliability of the FACT, as well as DIF and LID, using Rasch analysis in patients ranging from mild to severe cases of stroke admitted to a recovery-phase rehabilitation ward (equivalent to the subacute phase).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Functional Assessment for Control of Trunk (FACT)
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients hospitalized in a recovery-phase rehabilitation ward between April 2021 and April 2024 following their first-ever cerebral infarction or cerebral hemorrhage (those with a first-ever supratentorial lesion)
Key exclusion criteria
Patients with missing data required for analysis.
Patients who were transferred to another hospital or discharged due to death.
Patients who refused to participate in the study.
Patients for whom assessment was difficult due to impaired consciousness.
Patients with severe orthopedic or neuromuscular diseases other than stroke that affected trunk function.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Miyata |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Department of Physical Therapy
Zip code
300-0394
Address
4669-2 Ami, Ami Town, Inashiki District, Ibaraki Prefecture
TEL
029-888-4000
miyatak@ipu.ac.jp
Public contact
Name of contact person
| 1st name | Shunji |
| Middle name | |
| Last name | Araki |
Organization
Chuzan Hospital
Division name
Chuzan Hospital Clinical Education and Research Center
Zip code
904-2151
Address
6-2-1 Matsumoto, Okinawa City, Okinawa Prefecture
TEL
0989821346
Homepage URL
https://chuzan.or.jp/
tavarua.1s@gmail.com
Sponsor or person
Institute
Ibaraki Prefectural University of Health Sciences
Institute
Department
Personal name
Kazuhiro Miyata
Funding Source
Organization
No
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
Ibaraki Prefectural University of Health Sciences Ethics Review Committee
Address
4669-2 Ami, Ami Town, Inashiki District, Ibaraki Prefecture
Tel
0298884000
miyatak@ipu.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
ちゅうざん病院（沖縄県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research Design: Single-center retrospective observational study
[Statistical Analysis]
Scale Properties: Rasch analysis (item difficulty estimation, model fit, etc.)
DIF/LID
Statistical Software: Winsteps(Use R as needed)
Management information
Registered date
| 2026 | Year | 01 | Month | 20 | Day |
Last modified on
| 2026 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068997
