UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054654