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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048115
Receipt No. 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 2022/06/20

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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
Email 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
Email wakidam@makino.kmu.ac.jp

Sponsor
Institute Kansai Medical University
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2022 Year 05 Month 31 Day
Date of IRB
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 06 Month 20 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054654

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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