UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061072 |
|---|---|
| Receipt number | R000069883 |
| Scientific Title | Characteristics of body exploration behavior in post-stroke personal neglect: an investigation using the Fluff Test |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/03/26 22:20:29 |
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Basic information
Public title
A study on the characteristics of body-searching movements in patients with personal neglect following stroke
Acronym
A study on body exploration behavior in patients with personal neglect
Scientific Title
Characteristics of body exploration behavior in post-stroke personal neglect: an investigation using the Fluff Test
Scientific Title:Acronym
Body Exploration in Personal Neglect: Fluff Test Study
Region
| Japan |
Condition
Condition
Personal Neglect
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To quantify body exploration behavior during the Fluff Test in post-stroke personal neglect (PN) patients using markerless video analysis and inertial measurement units (IMU), and to characterize its features by comparing with healthy older adults and non-PN stroke patients.
Basic objectives2
Others
Basic objectives -Others
To quantitatively describe the characteristics of body exploration behavior (exploration range, exploration sequence, laterality of reach frequency, and head rotation pattern), and to clarify their association with the presence and severity of personal neglect.
Trial characteristics_1
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
[1] Laterality Index by video analysis (LI-video): asymmetry index based on the number of reaches toward the right vs. left body side, derived from markerless video analysis (MediaPipe + OpenCV) during the Fluff Test. [2] Laterality Index by IMU (LI-IMU): asymmetry index based on the ratio of dwell time in leftward vs. rightward head rotation (Yaw angle), measured by XSens MTw sensor during the Fluff Test.
Key secondary outcomes
1. First-reach latency to the left body side 2. Reciprocation count 3. Centroid slope of exploration trajectory 4. Correlations with clinical assessments: Catherine Bergego Scale (CBS) body subscale, Comb and Razor Test, neuropsychological tests
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Key inclusion criteria
Aged 18 years or older
First-ever right hemisphere stroke (ischemic or hemorrhagic)
Impairment in at least one of the following confirmed by neurological assessment: motor function, language, attention, or praxis
Sufficient arousal and attention to perform the task
Asymptomatic lacunar infarcts permitted up to 2 lesions with a diameter of <=15 mm each (recorded and considered during analysis)
Supplementary note
This study primarily targets patients with right hemisphere lesions; however, patients with left hemisphere lesions will also be included in the recording and analysis if personal neglect is confirmed.
Key exclusion criteria
Key exclusion criteria
Prior clinical stroke, multiple or large lacunar infarcts
History of head trauma
Difficulty performing the task or maintaining adequate arousal
Other severe neurological, psychiatric, or medical conditions
Clinically suspected dementia with difficulty following instructions (MMSE <=21 as a guide; however, patients are not uniformly excluded solely due to aphasia or attentional impairment)
Severe illness with a prognosis of less than 1 year
Contraindications to MRI (e.g., claustrophobia, metallic foreign bodies)
Severe visual field deficits (homonymous hemianopia and quadrantanopia are included but recorded)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kouku |
| Middle name | |
| Last name | Nishimaki |
Organization
Kamata Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
143-0015
Address
4-14-5 Omori-Nishi, Ota-ku, Tokyo
TEL
03-5767-7100
kuukokimashini9771@gmail.com
Public contact
Name of contact person
| 1st name | Kouku |
| Middle name | |
| Last name | Nishimaki |
Organization
Kamata Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
143-0015
Address
4-14-5 Omori-Nishi, Ota-ku, Tokyo
TEL
03-5767-7100
Homepage URL
kuukokimashini9771@gmail.com
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Kio University
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
Kamata Rehabilitation Hospital
Address
Omori-Nishi, Ota-ku, Tokyo
Tel
03-5767-7100
kuukokimashini9771@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
東京都
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 01 | 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 | 31 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational study. Factors examined: presence and severity of personal neglect (PN) assessed by CBS body subscale and Comb and Razor Test, lesion location and volume (MRI), motor paralysis, and cognitive function (MMSE). Outcomes examined: body exploration behavior indices during the Fluff Test (Laterality Index, first-reach latency, reciprocation count, Centroid slope of exploration trajectory, head rotation Laterality Index).
Management information
Registered date
| 2026 | Year | 03 | Month | 26 | Day |
Last modified on
| 2026 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069883
