UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047022 |
|---|---|
| Receipt number | R000053647 |
| Scientific Title | The effect of trunk position on attentional disorders of disengagement in patient with unilateral spatial neglect in acute phase |
| Date of disclosure of the study information | 2022/02/28 |
| Last modified on | 2024/06/30 20:51:28 |
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Basic information
Public title
The effect of trunk position on attentional disorders of disengagement in patient with unilateral spatial neglect in acute phase
Acronym
The effect of trunk position on attentional disorders of disengagement in patient with unilateral spatial neglect in acute phase
Scientific Title
The effect of trunk position on attentional disorders of disengagement in patient with unilateral spatial neglect in acute phase
Scientific Title:Acronym
The effect of trunk position on attentional disorders of disengagement in patient with unilateral spatial neglect in acute phase
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate that the effect of trunk position on attentional disorders of disengagement in patient with unilateral spatial neglect in acute phase
Basic objectives2
Others
Basic objectives -Others
To investigate that the effect of trunk position on attentional disorders of disengagement in patient with unilateral spatial neglect in acute phase
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Posner task
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
The inclusion criteria were patients (a) with first-ever cerebrovascular disease within 30 days of onset, (b) older than 20 years, (c) with right-handed, (d) with stable neurological symptoms, and (e) without respiratory or circulatory diseases that would interfere with evaluation or experiments.
Key exclusion criteria
The Exclusion criteria were patients (a) with impaired consciousness, aphasia, difficulty in understanding instructions due to dementia (Mini-Mental State Examination: MMSE <21 score), (b) who could not keep sitting position, (c)with visual field deficit, and (d) who did not give written consent.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Shida |
Organization
Saitama Medical University International Medical Center
Division name
Rehabilitation center
Zip code
350-1298
Address
1397-1 Yamane, Hidaka, Saitama 350-1298, Japan.
TEL
042-984-4367
tsurunan18@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Shida |
Organization
Saitama Medical University International Medical Center
Division name
Rehabilitation center
Zip code
350-1298
Address
1397-1 Yamane, Hidaka, Saitama 350-1298, Japan.
TEL
042-984-4367
Homepage URL
tsurunan18@yahoo.co.jp
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
Saitama Medical University International medical Center
Address
1397-1 Yamane, Hidaka, Saitama 350-1298, Japan
Tel
042-984-4523
chikens@saitama-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 | 02 | Month | 28 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2035-8377/14/4/83
Publication of results
Unpublished
Result
URL related to results and publications
https://www.mdpi.com/2035-8377/14/4/83
Number of participants that the trial has enrolled
38
Results
This study revealed the relationship between trunk position and attentional disengagement using the modified Posner task. Reaction time was reduced in the left trunk rotation condition.
These results suggest that spatial and temporal biases in patients with neglect symptoms could be related to information processing and integration.
Results date posted
| 2024 | Year | 06 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with a diagnosis of stroke who were admitted to the International Medical Center of Saitama Medical University between March 2020 and March 2022 were considered for participation.
Participant flow
Patients with early stroke onset who met the inclusion and exclusion criteria described below were included. Written informed consent was obtained from all participants and the study was conducted in accordance with the Declaration of Helsinki.
Adverse events
Nothing
Outcome measures
age, sex, number of days since onset, disease type, Mini-Mental State Examination (MMSE), Behavioral Inattention Test(BIT), Catherine Bergego Scale(CBS), and modified Posner task.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 04 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 08 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing
Management information
Registered date
| 2022 | Year | 02 | Month | 28 | Day |
Last modified on
| 2024 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053647
