UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048115 |
|---|---|
| Receipt number | R000054654 |
| Scientific Title | Motion analysis and development of training algorithm for fall prevention in older adults |
| Date of disclosure of the study information | 2022/06/20 |
| Last modified on | 2022/08/12 09:09:44 |
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Basic information
Public title
Motion analysis and development of training algorithm for fall prevention in older adults
Acronym
Motion analysis and development of training algorithm for fall prevention in older adults
Scientific Title
Motion analysis and development of training algorithm for fall prevention in older adults
Scientific Title:Acronym
Motion analysis and development of training algorithm for fall prevention in older adults
Region
| Japan |
Condition
Condition
Community-dwelling older adults
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to analyze the performance during dual-belt treadmill training and develop a treatment algorithm based on a predictive model using artificial intelligence according to the individual's ability.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in performance during a dual-belt treadmill training
Key secondary outcomes
Change in balance ability
Change in fall efficacy
Change in number of falls
Changes in temporal-spatial parameters during level walking
Change in cognitive function
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
gait training
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
Age 65 years and over
Able to walk indoors without a cane independently or with supervision.
Key exclusion criteria
A history of hospitalization or surgery within the past 3 months.
Pain affecting walking due to osteoarticular disease, etc.
Unable to understand the instructions due to cognitive impairment, etc.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Wakida |
Organization
Kansai Medical University
Division name
Faculty of Rehabilitation
Zip code
573-1136
Address
18-89 Uyama-higashimachi Hirakata, Osaka
TEL
0728562318
wakidam@makino.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Wakidam |
Organization
Kansai Medical University
Division name
Faculty of Rehabilitation
Zip code
573-1136
Address
18-89 Uyama-higashimachi, Hirakata, Osaka
TEL
0728562318
Homepage URL
wakidam@makino.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University Center for Ethical Review
Address
2-5-1 Shinmachi, Hirakata, Osaka
Tel
0728042440
rinriirb@hirakata.kmu.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
| 2022 | Year | 06 | Month | 20 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2024 | 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 | 06 | Month | 20 | Day |
Last modified on
| 2022 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054654
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
