UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Relationship between damage degree of cranial nerve fibers and rehabilitation evaluation in brain disorder patients
Title of the study (Brief title)	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	Yoshinori Nomura
Organization	Nagoya Kyoritsu Hospital
Division name	Rehabilitation
Address	1-172 Hokke, Nakagawa-ku, Nagoya-shi, Aichi
TEL	052-362-5151
Email	y_sawajima0124@yahoo.co.jp

Public contact
Name of contact person	Yuki Sawajima
Organization	Kaikoukai Rehabilitation Hospital
Division name	Rehabilitation
Address	5-20 Kando, Yatomi-shi, Aichi
TEL	0567-52-3883
Homepage URL
Email	y_sawajima0124@yahoo.co.jp

Sponsor
Institute	Nagoya Kyoritsu Hospital
Institute
Department

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 03 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035317