UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062864 |
|---|---|
| Receipt number | R000071808 |
| Scientific Title | Relationship between Unilateral Spatial Neglect Symptoms and Prism Adaptation Effect in Acute Stroke Patients |
| Date of disclosure of the study information | 2026/09/09 |
| Last modified on | 2026/09/09 19:14:24 |
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Basic information
Public title
Study of the Relationship Between Unilateral Spatial Neglect and the Effect of Prism Adaptation in Patients With Acute Stroke
Acronym
USN and PA in Acute Stroke
Scientific Title
Relationship between Unilateral Spatial Neglect Symptoms and Prism Adaptation Effect in Acute Stroke Patients
Scientific Title:Acronym
USN and PA in Acute Stroke
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate differences in the immediate effect of prism adaptation using virtual reality between patients with egocentric and allocentric unilateral spatial neglect after acute stroke.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in x-axis deviation from before to immediately after the VR-based prism adaptation task (after-effect). The x-axis deviation is measured immediately before and immediately after the prism adaptation task.
Key secondary outcomes
1.Change in the Behavioural Inattention Test (BIT) score during hospitalization.
2.Change in the Catherine Bergego Scale (CBS) score during hospitalization.
3.Change in the Ota test score during hospitalization.
4.Change in the National Institutes of Health Stroke Scale (NIHSS) score during hospitalization.
5.Change in the Barthel Index (BI) score during hospitalization.
6.Change in the Mini-Mental State Examination (MMSE) score during hospitalization.
7.Change in the Frontal Assessment Battery (FAB) score during hospitalization.
8.Simulator sickness assessed using the Simulator Sickness Questionnaire (SSQ).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Participants perform one prism adaptation task using a virtual reality system. The task consists of 20 reaches without prism deviation, 100 reaches with prism deviation, and 20 reaches without prism deviation. The x-axis deviation of the reaching position is measured immediately before and after the prism adaptation task to evaluate the after-effect.
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
| 5 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients with acute stroke admitted to the Stroke Center of Nagasaki University Hospital.
2.Patients with unilateral spatial neglect (USN) identified by the Behavioural Inattention Test (BIT) and Catherine Bergego Scale (CBS).
3.Patients who provide written informed consent after receiving an explanation of the study, or whose legally authorized representative provides consent.
Key exclusion criteria
1.Individuals with a history of cerebrovascular disease
2.Individuals with brainstem lesions
3.Individuals with visual impairment (including those with untreated ophthalmic conditions)
4.Individuals exhibiting cognitive decline (Mini-Mental State Examination score of 15 or lower)
5.Individuals unable to maintain a seated position in a wheelchair, or those experiencing blood pressure fluctuations associated with maintaining a seated posture
6.Any other patients deemed unsuitable for the study by the principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Takahashi |
Organization
Nagasaki University Hospital
Division name
Department of Rehabilitation
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture
TEL
0958197258
h-takahashi@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Takahashi |
Organization
Nagasaki University Hospital
Division name
Department of Rehabilitation
Zip code
8528501
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture
TEL
0958197258
Homepage URL
h-takahashi@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Hiroki Takahashi
Funding Source
Organization
Self funding
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
Nagasaki University Hospital
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki Prefecture
Tel
0958197229
kenkyurinri@ml.nagasaki-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
| 2026 | Year | 09 | Month | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Participants began to be enrolled in this study on July 15, 2025. The study is being registered with UMIN-CTR after the start of the study; therefore, participant enrollment and study procedures had already been initiated before registration with UMIN-CTR. In accordance with the study protocol, participants undergo the Ota test, one session of a virtual reality (VR)-based prism adaptation task followed by an assessment of the after-effect, and the Simulator Sickness Questionnaire (SSQ). Participants are classified into egocentric and allocentric neglect groups based on the Ota test, and the after-effect following the prism adaptation task is compared between the two groups.
Management information
Registered date
| 2026 | Year | 09 | Month | 09 | Day |
Last modified on
| 2026 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071808
