UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046140 |
|---|---|
| Receipt number | R000046071 |
| Scientific Title | A study on the relationship between frontal cerebral blood flow changes and falls during walking |
| Date of disclosure of the study information | 2021/11/24 |
| Last modified on | 2024/06/07 19:20:43 |
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Basic information
Public title
A study on the relationship between frontal cerebral blood flow changes and falls during walking
Acronym
A study on the relationship between frontal cerebral blood flow changes and falls during walking
Scientific Title
A study on the relationship between frontal cerebral blood flow changes and falls during walking
Scientific Title:Acronym
A study on the relationship between frontal cerebral blood flow changes and falls during walking
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the relationship between changes in frontal cerebral blood flow and fall risk when cognitive stimuli are given during walking, including relationships with cognitive and physical abilities.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in oxygenated hemoglobin
Key secondary outcomes
10m walking speed,Berg burg scale,Timed-up and go test,One-leg standing time,muscle strength of lower extremities, CS-5,Grip strength,Skeletal muscle mass,Threshold of fall,Trai Making Test(TMT), Clinical Assessment for Attention(CAT), Mini-Mental State Examination(MMSE), Life space assessment
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
2 times interventions
Double task walking using NIRS on treadmill
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy people of the daily living independent
Person who can walk 10m
Key exclusion criteria
Those who are prohibited from exercise by the doctor.
A history of acute illness requiring hospitalization within the past 3 months.
Dementia.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshio |
| Middle name | |
| Last name | Takano |
Organization
International University Health and Welfare
Division name
Department of Physical Therapy School of Health Sciences at Fukuoka
Zip code
8318501
Address
137-1 Enokizu, Okawa, Fukuoka JAPAN
TEL
0944892000
y-takano@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Yoshio |
| Middle name | |
| Last name | Takano |
Organization
International University Health and Welfare
Division name
Department of Physical Therapy School of Health Sciences at Fukuoka
Zip code
8318501
Address
137-1 Enokizu, Okawa, Fukuoka JAPAN
TEL
0944892000
Homepage URL
y-takano@iuhw.ac.jp
Sponsor or person
Institute
International University Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
SK-Electronics Co.,LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University Health and Welfare
Address
137-1 Enokizu, Okawa, Fukuoka JAPAN
Tel
0944892000
y-takano@iuhw.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
久留米大学医療センター、大牟田吉野病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 24 | 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
20
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Data. Analysis is underway.
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
Completed
Date of protocol fixation
| 2021 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2021 | Year | 11 | Month | 22 | Day |
Last modified on
| 2024 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046071
