UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041231 |
|---|---|
| Receipt number | R000047083 |
| Scientific Title | Changes in cerebral blood flow due to the involvement of nurses in a remote environment in cognitive rehabilitation |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2020/07/28 13:30:47 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Changes in cerebral blood flow due to the involvement of nurses in a remote environment in cognitive rehabilitation
Acronym
Changes in cerebral blood flow due to the involvement of nurses in a remote environment in cognitive rehabilitation
Scientific Title
Changes in cerebral blood flow due to the involvement of nurses in a remote environment in cognitive rehabilitation
Scientific Title:Acronym
Changes in cerebral blood flow due to the involvement of nurses in a remote environment in cognitive rehabilitation
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Basic data for nurses to perform cognitive rehabilitation for elderly people in a remote environment, verify changes in cerebral blood flow due to the involvement of nurses, and examine effective cognitive rehabilitation implementation methods
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Regarding the cerebral blood flow data, the Hb T change value with 0 at the start of measurement is compared before and after the median value and the interquartile range (IQR) before and after the involvement of the nurse.
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Subject gazes at plain drawing paper for 90 seconds. We collect the values obtained from fNIRS. Subjects perform the same tasks as cognitive rehabilitation performed alone. At that time, the nurse interacts with the subject in a remote environment. We collect the values obtained from fNIRS.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
65 years old or older living in Takatsuki City, who do not interfere with daily life in terms of sight, hearing and language ability. It is intended for those who use health salons and day services implemented at joint research facilities. About 40 elderly people participate in health salons and day services conducted at the joint research facility. From the previous studies, it is estimated that the number of people who can carry out the exercise is about 10 people. Participants will be added each time there is a subject that can be conducted within the study period.
Key exclusion criteria
Those with a history of mental illness or cerebrovascular disease and higher brain dysfunction, those with an MMSE of 23 or less, and those with visual acuity or hearing that are difficult to live in daily life are excluded.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masakazu |
| Middle name | |
| Last name | Kubota |
Organization
Osaka Medical College
Division name
Faculty of Nursing
Zip code
5690095
Address
7-6 Hacchonishi-machi, Takatsuki-City, Osaka
TEL
0726847223
fon153@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | Masakazu |
| Middle name | |
| Last name | Kubota |
Organization
Osaka Medical College
Division name
Faculty of Nursing
Zip code
5690095
Address
7-6 Hacchonishi-machi, Takatsuki-City, Osaka
TEL
0726847223
Homepage URL
fon153@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College
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
Osaka Medical College
Address
7-6 Hacchonishi-machi, Takatsuki-City, Osaka
Tel
0726847223
fon153@osaka-med.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
| 2020 | Year | 10 | Month | 01 | 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
| 2020 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2020 | Year | 07 | Month | 28 | Day |
Last modified on
| 2020 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047083
