UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059099 |
|---|---|
| Receipt number | R000067567 |
| Scientific Title | Behavioral and neural associations between olfactory, motor, and cognitive impairments in patients receiving rehabilitation treatments |
| Date of disclosure of the study information | 2025/09/16 |
| Last modified on | 2025/09/16 17:36:56 |
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Basic information
Public title
Behavioral and neural associations between olfactory, motor, and cognitive impairments in patients receiving rehabilitation treatments
Acronym
Behavioral and neural associations between olfactory, motor, and cognitive impairments in patients receiving rehabilitation treatments
Scientific Title
Behavioral and neural associations between olfactory, motor, and cognitive impairments in patients receiving rehabilitation treatments
Scientific Title:Acronym
Behavioral and neural associations between olfactory, motor, and cognitive impairments in patients receiving rehabilitation treatments
Region
| Japan |
Condition
Condition
patients receiving rehabilitation treatments
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This research project has two objectives. One objective is to investigate (1) the prevalence of olfactory impairments in patients receiving rehabilitation treatments, (2) associations between olfactory impairments and cognitive/motor impairments and outcomes, and (3) their underlying neural mechanisms. The other objective is to elucidate general/inherent associations between olfactory functions and cognitive/motor functions, in particular those relevant to rehabilitation such as memory, learning, and emotion, through behavioral experiments.
Basic objectives2
Others
Basic objectives -Others
associations between olfactory, motor, and cognitive functions and impairments
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
clinical assessments (such as FIM, SIAS, MMSE, and MoCA-J), olfactory abilities, psychological and physiological responses to olfactory stimuli
Key secondary outcomes
demographics, behavioral (non-clinical) assessments of motor and cognitive functions, brain images
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
behavioral assessments on olfactory, motor, and/or cognitive functions, brain imaging, regular clinical physical/functional evaluations
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
patients
a) inpatients/outpatients of the rehabilitation department at Fujita Health University Hospital
b) being able to maintain sitting posture on a chair with a backrest
c) a current diagnosis or a history of an olfactory, motor or cognitive impairment
d) an adult (18 years or older) who can provide informed consent by oneself.
healthy individuals
a) no history of brain, neuromuscular, or psychological diseases and no history of epileptic seizure
b) an adult (18 years or older) who can provide informed consent by oneself.
Key exclusion criteria
patients
A) unable to maintain sitting posture on a chair with a backrest
B) unable to follow instructions by physicians, therapists, or other health practitioners
C) a history of epileptic seizure
D) currently pregnant
E1) (only for those who receive MRI scanning) having in the body a pacemaker, aneurysm clip, pump, electrodes, or any other metal object that may be incompatible with MRI.
E2) (only for those who receive MRI scanning) unable to maintain supine posture during MRI scanning
healthy individuals
A) a history of a brain, neuromuscular, or psychological disease or a history of epileptic seizure
B) currently pregnant
C1) (only for those who receive MRI scanning) having in the body a pacemaker, aneurysm clip, pump, electrodes, or any other metal object that may be incompatible with MRI.
C2) (only for those who receive MRI scanning) having non-removable makeup/tattoo/accessory that either (a) is too close to the head/neck, (b) contains MRI-incompatible metals, (c) is so wide/large that it may compromise safety during MRI scanning
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562-93-2167
rehabmed@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562-93-2167
Homepage URL
otaka119@mac.com
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee of Fujita Health University
Address
1-98, Dengakugakubo Kutsukake-cho, Toyoake-shi Aichi 470-1192, Japan
Tel
0562-93-2865
f-irb@fujita-hu.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
藤田医科大学病院(愛知県)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 16 | 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 | 31 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 22 | 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
Management information
Registered date
| 2025 | Year | 09 | Month | 16 | Day |
Last modified on
| 2025 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067567
