UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030990 |
|---|---|
| Receipt number | R000035317 |
| Scientific Title | Relationship between damage degree of cranial nerve fibers and rehabilitation evaluation in brain disorder patients |
| Date of disclosure of the study information | 2018/01/25 |
| Last modified on | 2018/01/25 13:44:51 |
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Basic information
Public title
Relationship between damage degree of cranial nerve fibers and rehabilitation evaluation in brain disorder patients
Acronym
Relationship between brain damage degree and rehabilitation assessment in brain disorder patients
Scientific Title
Relationship between damage degree of cranial nerve fibers and rehabilitation evaluation in brain disorder patients
Scientific Title:Acronym
Relationship between brain damage degree and rehabilitation assessment in brain disorder patients
Region
| Japan |
Condition
Condition
Cerebral vascular disease
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we investigated the degree of damage and cognitive function of cranial nerve fibers using Diffusion Tensor Imaging (DTI) of Magnetic Resonance Imaging (MRI) of brain disorder patients, Activities of Daily Living (ADL) ability, etc. for five years in a positive manner, and to clarify the influence of degree of damage of cranial nerve fibers on brain disorder patients on physical functions. There are few studies investigating the relationship between the degree of damage of cranial nerve fibers and various rehabilitation evaluations, and it is possible to accurately grasp the medical condition and prognosis accurately from the early stage, and it is possible to provide effective rehabilitation I think that it is meaningful in terms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diffusion anisotropy (FA value) using diffusion tensor images, Brunnstrom Stage, National Institute of Health Stroke Scale (NIHSS), Modified Rankin Scale (mRS), 10 m walking time, Mini Mental State Examination (MMSE) Trail Making Test (TMT), Functional Independence Measure (FIM)
Key secondary outcomes
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 |
Interventions/Control_1
About 30 brain disorder patients who entered a subject of research in this hospital. A radiographer takes a picture of a diffusion tensor picture of MRI based on development 15-prescription which is a doctor on the 28th. Photography time is put into effect in 5-10 minutes.., it's based on the report that the crowd who took a picture of Know on 15th-the 28th compared with the early stage photography crowd who took a picture of 1) within 14 days has higher predictability as development 15-grounds performed on the 28th. But, I'll take a picture by leaving about the person who leaves within 14 days. A radiographer digitizes the damage level of the cranial nerve fiber in a corticospinal way and a cortical reticular formation way by FA value as well as draws TORAFUTOGURAFI and checks it visually from the picture. The physical therapy man a physical therapy man puts the following rehabilitation evaluation into effect at the time of a foreign check-up at the time of leaving at the time of the first time intervention time and diffusion tensor picture photography, and who is concerned with the patient who became hospital transfer in a kaigyoukai rehabilitation hospital, and a kaigyoukai rehabilitation hospital, the first time intervention time and, when leaving a hospital every 1 month, I measure. A relation between the damage level of the obtained cranial nerve fiber (FA value) and all kinds' rehabilitation evaluation result is analyzed in statistical way. Participation of a study obtains consent in oral and a document and puts it into effect to the target by which consent was got.
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
| 15 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients admitted to our hospital due to brain injury
Key exclusion criteria
ADL is fully independent
Those who required severe physical assistance for ADL before onset due to past brain disorders, medical disorders and orthopedic diseases
Those who can not obtain consent to participate in the research
Persons whose medical condition is not stable and rehabilitation can not be enforced
Persons whose function evaluation is extremely difficult to perform due to severe cognitive impairment
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinori Nomura |
Organization
Nagoya Kyoritsu Hospital
Division name
Rehabilitation
Zip code
Address
1-172 Hokke, Nakagawa-ku, Nagoya-shi, Aichi
TEL
052-362-5151
y_sawajima0124@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuki Sawajima |
Organization
Kaikoukai Rehabilitation Hospital
Division name
Rehabilitation
Zip code
Address
5-20 Kando, Yatomi-shi, Aichi
TEL
0567-52-3883
Homepage URL
y_sawajima0124@yahoo.co.jp
Sponsor or person
Institute
Nagoya Kyoritsu Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagoya Kyoritsu Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | 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
| 2017 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 25 | Day |
Last modified on
| 2018 | 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=R000035317
