UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038024 |
|---|---|
| Receipt number | R000043350 |
| Scientific Title | Acquisitions of image data for visual diagnosis by specialists and sensor data on gait and falls in elderly people. |
| Date of disclosure of the study information | 2019/09/18 |
| Last modified on | 2021/10/07 12:02:40 |
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Basic information
Public title
Acquisitions of image data for visual diagnosis by specialists and sensor data on gait and falls in elderly people.
Acronym
Acquisitions of gait data from wearable foot sensor and gait images for visual diagnosis.
Scientific Title
Acquisitions of image data for visual diagnosis by specialists and sensor data on gait and falls in elderly people.
Scientific Title:Acronym
Acquisitions of gait data from wearable foot sensor and gait images for visual diagnosis.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed at understanding the relationship between the gait of elderly people and the probability of their future falls by acquiring gait data and gait images for visual diagnosis by specialists, for the purpose of encouraging nursing home users to change behaviors to prevent falls.
Basic objectives2
Others
Basic objectives -Others
Research
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Gait acquired from a wearable foot sensor and images.
2. Modified Gait Abnormality Rating Scale (GARS-M)
3. 5-question Geriatric Locomotive Function Scale
4. Survey of the history of falls
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
We measure foot pressure, foot deformity, and change in acceleration during gate by using wearable foot sensor and conduct upright posture and gait measurements.
We capture a video of walking and make a visual diagnosis of gait using the GARS-M.
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
1. 65 years old or older (at the time of submission of an informed consent document).
2. Males and females.
3. Those who can walk independently.
4. Individuals who require support level 1 or not applicable by the national long-term care insurance system.
5. Those who can provide a written informed consent.
Key exclusion criteria
1. Those who seem to have communication difficulties (such as dementia and mental disorders).
2. Individuals who require support level 2 and have been certified as need-to-care level 1~5 by the national long-term care insurance system.
3. Those who were determined to be unsuitable for participation in this clinical trial, in the opinion of the principal investigator.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Noritsune |
| Middle name | |
| Last name | Yokoyama |
Organization
Hiroshima Prefectural Technology
Research Institute
Division name
Product Design and Engineering Research Division
Zip code
739-0046
Address
3-13-26 Kagamiyama,Higashi-Hiroshima-Shi, Hiroshima,Japan
TEL
082-420-0537
n-yokoyama86059@pref.hiroshima.lg.jp
Public contact
Name of contact person
| 1st name | Noritsune |
| Middle name | |
| Last name | Yokoyama |
Organization
Hiroshima Prefectural Technology Research Institute
Division name
Product Design and Engineering Research Division
Zip code
739-0046
Address
3-13-26 Kagamiyama,Higashi-Hiroshima-Shi, Hiroshima,Japan
TEL
082-420-0537
Homepage URL
n-yokoyama86059@pref.hiroshima.lg.jp
Sponsor or person
Institute
Kaneka Corporation
Institute
Department
Personal name
Funding Source
Organization
KANEKA Corporation
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Prefectural University of Hiroshima
Hiroshima Prefectural Technology Research Institute
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Suda Clinic institutional review board
Address
2-8-14, Takadanobaba, Shinjyuku, Tokyo, Japan
Tel
03-6205-6222
suda-clinic_irb@imeq.co.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 | 09 | Month | 18 | 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
Completed
Date of protocol fixation
| 2019 | Year | 07 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2021 | Year | 07 | 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
| 2019 | Year | 09 | Month | 17 | Day |
Last modified on
| 2021 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043350
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