UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057401 |
|---|---|
| Receipt number | R000064936 |
| Scientific Title | Development of a Fall Prediction System for Patients with Stroke Using Quantitative Assessment of the Vestibulo-Ocular Reflex |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/01/25 14:31:45 |
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Basic information
Public title
Development of a Fall Prediction System for Patients with Stroke Using Quantitative Assessment of the Vestibulo-Ocular Reflex
Acronym
Development of a Fall Prediction System for Patients with Stroke Using Quantitative Assessment of the Vestibulo-Ocular Reflex
Scientific Title
Development of a Fall Prediction System for Patients with Stroke Using Quantitative Assessment of the Vestibulo-Ocular Reflex
Scientific Title:Acronym
Development of a Fall Prediction System for Patients with Stroke Using Quantitative Assessment of the Vestibulo-Ocular Reflex
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives are: (1) to examine the reliability and validity of vestibulo-ocular reflex measurements in patients with stroke, (2) to elucidate the characteristics of balance impairments, including vestibular dysfunction, following stroke, and (3) to develop a high-precision fall risk prediction system based on these findings.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Falls after discharge and details
Key secondary outcomes
Gain of the Vestibulo-Ocular Reflex Measured by the Video Head Impulse Test, Other vestibular functions, motor functions, and basic attributes
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
1. Inpatients with stroke involving subtentorial or basal ganglia lesions,
2. Individuals aged 18 years or older,
3. Those who provide informed consent to participate in the study of their own free will,
4. Individuals who were independent in walking prior to the onset of stroke.
Key exclusion criteria
1. Individuals with a history of auditory, visual, or orthopedic conditions that interfere with the measurements,
2. Individuals with significant cognitive decline,
3. Individuals deemed unsuitable for study participation by their attending physician.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Igarashi |
Organization
Bunkyo Gakuin University
Division name
Department of Physical Therapy
Zip code
356-0051
Address
1196 Kamekubo, Fujimino- shi, Saitama, Japan
TEL
049-261-6488
t-igarashi@bgu.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Igarashi |
Organization
Bunkyo Gakuin University
Division name
Department of Physical Therapy
Zip code
356-0051
Address
1196 Kamekubo, Fujimino- shi, Saitama, Japan
TEL
049-261-6488
Homepage URL
t-igarashi@bgu.ac.jp
Sponsor or person
Institute
Bunkyo Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Bunkyo Gakuin 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
Social Medical Corporation Kijokai
Address
8 Sakaemachi, Numata-city, Gunma 378-0014, Japan
Tel
0278225052
t-igarashi@bgu.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
| 2025 | 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 | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Design: Longitudinal observational study
Baseline Assessments: Grading of Lateropulsion (GoL), Scale for the Assessment and Rating of Ataxia (SARA), Subjective Visual Vertical (SVV), nystagmus, Berg Balance Scale (BBS), modified Clinical Test of Sensory Interaction on Balance (mCTSIB), 10-meter walk test, Functional Gait Assessment (FGA), symptoms of dizziness, sense of unsteadiness, and the lower extremity section of the Fugl-Meyer Assessment.
Follow-up: Fall incidents after discharge.
Management information
Registered date
| 2025 | Year | 03 | Month | 26 | Day |
Last modified on
| 2025 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064936
