UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035674 |
|---|---|
| Receipt number | R000040636 |
| Scientific Title | Comprehensive understanding of neural substrates underlying sensorimotor impairments and their recovery in patients receiving rehabilitative treatments |
| Date of disclosure of the study information | 2019/01/25 |
| Last modified on | 2024/01/29 11:14:21 |
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Basic information
Public title
Comprehensive understanding of neural substrates underlying sensorimotor impairments and their recovery in patients receiving rehabilitative treatments
Acronym
Understanding neural substrates of sensorimotor impairments and their recovery
Scientific Title
Comprehensive understanding of neural substrates underlying sensorimotor impairments and their recovery in patients receiving rehabilitative treatments
Scientific Title:Acronym
Understanding neural substrates of sensorimotor impairments and their recovery
Region
| Japan |
Condition
Condition
Healthy adults and patients with sensorimotor impairments
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study aims to comprehensively understand neural substrates underlying improvements in sensorimotor functions in healthy adults and patients with impairments such as after suffering stroke, using behavioral, neurophysiological, and brain imaging evaluations.
Basic objectives2
Others
Basic objectives -Others
Time-course changes in sensorimotor functions and indices of neural system
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Indices for sensorimotor functions
Key secondary outcomes
Clinical indices for physical functions and activities
Conventional rehabilitative evaluations such as muscle strength, spasticity, and activity of daily living, etc.
Behavioral indices for sensorimotor functions evaluated with experimental tasks
Experimental evaluations for quality of movements, e.g. smoothness, speed, accuracy, and learning ability.
Neurophysiological indices
Neurophysiological evaluations using transcranial magnetic stimulation and/or peripheral electrical stimulation.
Brain imaging data
Features of brain structure evaluated by magnetic resonance imaging.
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
| Device,equipment | Behavior,custom |
Interventions/Control_1
Neurophysiological, behavioral, clinical physical/functional evaluations, brain imaging, and rehabilitative training.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients
a. A person referred to a rehabilitation department for sensorimotor impairments in the extremities or trunk
b. Able to keep sitting without help
c. Consent to participate in the study
Healthy adults
a. A person with no past history of brain diseases, neurologic/muscular diseases, cardiovascular diseases, or epilepsy
b. Consent to participate in the study
Key exclusion criteria
Patients
a. Unable to keep sitting without help
b. Past history of epilepsy
c. Having cardiac pacemakers, implanted electrodes in the body, or undetachable metal anywhere near the head
d. Pregnancy
Healthy adults
a. Past history of brain diseases, neurologic/muscular diseases, cardiovascular diseases, or epilepsy
b. Having cardiac pacemakers, implanted electrodes in the body, or undetachable metal anywhere near the head
c. Pregnancy
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 I
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 I
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, Science and Technology-Japan
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, Aichi, 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（愛知県） Fujita Health University
藤田医科大学病院（愛知県）Fujita Health University Hospital
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 25 | 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
| 2019 | Year | 01 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2026 | 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
| 2019 | Year | 01 | Month | 25 | Day |
Last modified on
| 2024 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040636
