UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049284 |
|---|---|
| Receipt number | R000056126 |
| Scientific Title | Validation of usefulness of a fall prevention device by motion analysis using markerless motion capture in simulated fall scenes in the daily life of healthy adults |
| Date of disclosure of the study information | 2022/10/27 |
| Last modified on | 2025/01/29 10:07:58 |
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Basic information
Public title
Validation of usefulness of a fall prevention device using markerless motion capture in simulated fall scene
Acronym
Validation of usefulness of fall shock mitigation device in simulated fall scene
Scientific Title
Validation of usefulness of a fall prevention device by motion analysis using markerless motion capture in simulated fall scenes in the daily life of healthy adults
Scientific Title:Acronym
Validation of usefulness of fall shock mitigation device in simulated fall scene
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Rehabilitation medicine | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Validation of usefulness of fall impact suspension device
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fall velocity of head and center of gravity
Key secondary outcomes
Position coordinates of center of gravity and joint center and their respective accelerations, joint angles and angular accelerations
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
| Other |
Interventions/Control_1
Simulated fall with fall suspension device to measure head and center of gravity velocities. Falls when transferring in activities of daily living, falls due to stumbling, and falls during straddling are performed several times each./no controls
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Physical therapists, occupational therapists, speech-language pathologists, nurses, students, researchers working at the Center, and General healthy people.
Key exclusion criteria
Exclusion criteria are those with osteoporosis, fractures, spinal disease, or brain disease.
Target sample size
100
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
Assistive Robot Center
Zip code
4748511
Address
7-430, Morioka, Obu, Aichi 474-8511, JAPAN
TEL
0562462311
ik7710@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Kato |
Organization
National Center for Geriatrics and Gerontology
Division name
Laboratory for Clinical Evaluation with Robotics, Assistive Robot Center
Zip code
4748511
Address
7-430, Morioka, Obu, Aichi 474-8511, JAPAN
TEL
0562462311
Homepage URL
kk0724@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics and Conflict of Interest Committee, National Center for Geriatrics and Gerontology
Address
7-430, Morioka, Obu, Aichi 474-8511, JAPAN
Tel
0562462311
IRB@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
国立長寿医療研究センター（愛知県）/ National Center for Geriatrics and Gerontology
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2027 | 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
| 2022 | Year | 10 | Month | 21 | Day |
Last modified on
| 2025 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056126
