UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055922 |
|---|---|
| Receipt number | R000063902 |
| Scientific Title | Relationship between Behavioral Observational Rating Scale of Attention Function and ADL in Acute Stroke Patients |
| Date of disclosure of the study information | 2024/10/23 |
| Last modified on | 2026/02/25 13:25:41 |
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Basic information
Public title
Relationship between Behavioral Observational Rating Scale of Attention Function and ADL in Acute Stroke Patients- Clinical usefulness of Behavioral Observational Rating Scale -
Acronym
Relationship between Observational Rating Scale and ADL
Scientific Title
Relationship between Behavioral Observational Rating Scale of Attention Function and ADL in Acute Stroke Patients
Scientific Title:Acronym
Relationship between Observational Rating Scale and ADL
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the relationship between behavioral observation assessment of attentional function and ADL independence and destination, and to clarify the usefulness of behavioral observation assessment in clinical practice.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ADL evaluation: Bathel Index (BI), Functional Independence Measure (FIM)
Behavioral observational Rating Scale: Moss Attention Rating Scale (MARS)
destination: discharged home or transferred to another hospital
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with stroke (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage) within 1 week of onset
Key exclusion criteria
Persons with dementia, psychiatric disorders, orthopedic disorders, and severe respiratory and circulatory disorders.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Miyauchi |
Organization
Shonan University of Medical Sciences
Division name
Faculty of Medical Sciences
Zip code
244-0806
Address
16-48, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL
045-821-0111
takayuki.miyauchi@sums.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Miyauchi |
Organization
Shonan University of Medical Sciences
Division name
Faculty of Medical Sciences
Zip code
244-0806
Address
16-48, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL
045-821-0111
Homepage URL
takayuki.miyauchi@sums.ac.jp
Sponsor or person
Institute
Shonan University of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shonan University of Medical Sciences
Address
16-48, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
Tel
045-821-0111
takayuki.miyauchi@sums.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
聖マリアンナ医科大学横浜市西部病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 23 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000063902
Publication of results
Partially published
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000063902
Number of participants that the trial has enrolled
200
Results
A longitudinal study examining the relationship between behavioral observation assessment and ADL revealed a significant correlation. Multivariate analysis also identified behavioral observation assessment as an independent factor associated with ADL independence.
Similarly, when investigating the relationship between toileting activities and behavioral observation assessment, behavioral observation assessment was identified as a factor associated with independence in toileting activities.
Results date posted
| 2025 | Year | 10 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants were individuals hospitalized in acute-care hospitals for the purpose of stroke treatment.
Participant flow
Participants underwent evaluations conducted within regular rehabilitation sessions during rehabilitation hours, with periodic evaluations performed once a week.
Adverse events
None
Outcome measures
The primary outcome was the Barthel Index (BI) and MARS, a measure of ADL. Secondary outcomes included clinical background factors, neurological tests, and neuropsychological tests.
Clinical background factors included sex, age, diagnosis, lesion site, First evaluation date from the onset, surgery history, dominant hand, discharge date, and discharge destination.
Neurological tests included the Brunnstrom Recovery Stage (BRS), grip strength, one-leg standing time (1LST), and 10-meter walking test. The severity of paralysis was categorized as severe for BRS stages I and II, moderate for stages III and IV, and mild for stages V and VI. Grip strength and 1LST were measured once for each side, and average values were calculated. The 10-meter walking test was conducted at a comfortable walking speed, and the distance covered per second (m/s) was calculated.
Neuropsychological assessments included the Mini-Mental State Examination (MMSE), Trail Making Test (TMT), Frontal Assessment Battery (FAB), Symbol Digit Modalities Test (SDMT), and MARS.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Although data analysis is still in progress, there is a high possibility that the level of independence in ADLs is related to behavior observation in a longitudinal study.
It is highly likely that the behavior observation evaluation will be useful even if the data are analyzed by individual movement.
Management information
Registered date
| 2024 | Year | 10 | Month | 23 | Day |
Last modified on
| 2026 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063902
