UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036171 |
|---|---|
| Receipt number | R000041210 |
| Scientific Title | Observational study on gait change in the physical frailty using digital human technology |
| Date of disclosure of the study information | 2019/03/14 |
| Last modified on | 2022/11/01 16:00:20 |
* 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
Study on gait change in the physical frailty using digital human technology
Acronym
Study of physical frailty using digital human technology
Scientific Title
Observational study on gait change in the physical frailty using digital human technology
Scientific Title:Acronym
Observational study of physical frailty using digital human technology
Region
| Japan |
Condition
Condition
Physical frailty
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To understand characteristics and factors about change of gait in the frailty using the computer simulation.
Basic objectives2
Others
Basic objectives -Others
To understand characteristics and factors about change of gait in the frailty
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gait analysis data
(Marker position, ground reaction force)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Independent walking for six minutes
Informed-consent has been obtained
Key exclusion criteria
High-blood pressure(systolic blood pressure less than 180 mmHg or diastolic blood pressure more than 120 mmHg or resting heart rate more than 120/min)
Restricted exercise due to heart function or respiratory function disorder
To need substitute to sign consent form
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Izumi] |
| Middle name | |
| Last name | Kondo |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Rehabilitation medicine
Zip code
474-8511
Address
7-430, Morioka-cho, Obu-shi, Aichi, 474-8511, Japan
TEL
0562-46-2311
ik7710@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Izumi |
| Middle name | |
| Last name | Kondo |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Rehabilitation medicine
Zip code
474-8511
Address
7-430, Morioka-cho, Obu-shi, Aichi, 474-8511, Japan
TEL
0562-46-2311
Homepage URL
ik7710@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Toyota motor corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo Metropolitan University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee of the National Center for Geriatrics and Gerontology
Address
7-430, Morioka-cho, Obu-shi, Aichi, 474-8511, Japan
Tel
0562-46-2311
ik7710@ncgg.go.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
| 2019 | Year | 03 | Month | 14 | Day |
Related information
URL releasing protocol
https://www.ncgg.go.jp/index.html
Publication of results
Unpublished
Result
URL related to results and publications
https://www.ncgg.go.jp/index.html
Number of participants that the trial has enrolled
18
Results
Simulations were performed from reflective marker and floor reaction force data.
Older adults were likely to have more neural activity during walking.
Results date posted
| 2022 | Year | 11 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
young peple 10 people, 21 years (SD:1)
plder adults 8 people,79 years (SD:4)
Participant flow
Written informed consent was obtained from each participant prior to participation.
Adverse events
no
Outcome measures
marker position, force plate data
Data from simulations (neural activity, work rate)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2019 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 03 | Month | 14 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2019 | Year | 03 | Month | 12 | Day |
Last modified on
| 2022 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041210
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
