UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061166 |
|---|---|
| Receipt number | R000069997 |
| Scientific Title | A Fundamental Study of Brain Representation Mechanisms Using fNIRS: Insights into Verticality Perception and Balance Control |
| Date of disclosure of the study information | 2026/04/07 |
| Last modified on | 2026/04/06 10:28:30 |
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Basic information
Public title
A Fundamental Study of Brain Representation Mechanisms Using fNIRS: Insights into Verticality Perception and Balance Control
Acronym
A Fundamental Study of Brain Representation Mechanisms Using fNIRS: Insights into Verticality Perception and Balance Control
Scientific Title
A Fundamental Study of Brain Representation Mechanisms Using fNIRS: Insights into Verticality Perception and Balance Control
Scientific Title:Acronym
A Fundamental Study of Brain Representation Mechanisms Using fNIRS: Insights into Verticality Perception and Balance Control
Region
| Japan |
Condition
Condition
Healthy participants, Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to elucidate the neural substrates underlying balance assessment and to clarify clinical applications by identifying the underlying mechanisms of balance training.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
fNIRS, Subjective Postural Vertical, Berg Balance Scale
Key secondary outcomes
Scale for contraversive Pushing(SCP), Center of Pressure(COP), Trunk Control Test(TCT), Functional in Sitting Test(FIST), Functional Independence Measure(FIM)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver | Other |
Interventions/Control_1
Interventions consist of truncal tilt training performed under two conditions. The specific intervention involving a wedge involves inserting a wedge under the ischial tuberosity on the hemiparetic side during maximum lateral truncal tilt training.
Interventions/Control_2
The control group performs maximum lateral truncal tilt training without a wedge.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with first-ever stroke resulting in hemiplegia
Presence of supratentorial lesions
Individuals who provided informed consent after receiving a verbal explanation
Key exclusion criteria
Withdrawal of consent or a request to decline participation by the subject.
Cases where the principal investigator or sub-investigator determines that discontinuation is appropriate for other reasons.
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Kota |
| Middle name | |
| Last name | Sawa |
Organization
SBC Tokyo Medical University
Division name
Department of Physical Therapy, Faculty of Heath Sciences
Zip code
279-8567
Address
5-8-1, Akemi, Urayasu, Chiba, Japan
TEL
+81473822617
kota-s@sbctmu.ac.jp
Public contact
Name of contact person
| 1st name | Kota |
| Middle name | |
| Last name | Sawa |
Organization
SBC Tokyo Medical University
Division name
Department of Physical Therapy, Faculty of Heath Sciences
Zip code
279-8567
Address
5-8-1, Akemi, Urayasu, Chiba, Japan
TEL
+81473822617
Homepage URL
kota-s@sbctmu.ac.jp
Sponsor or person
Institute
SBC Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
SBC Tokyo Medical 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
SBC Tokyo Medical University
Address
5-8-1, Akemi, Urayasu, Chiba, Japan
Tel
+81473822617
kota-s@sbctmu.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 | 04 | Month | 07 | 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
| 2026 | Year | 04 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 07 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 06 | Day |
Last modified on
| 2026 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069997
