UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057218 |
|---|---|
| Receipt number | R000065212 |
| Scientific Title | Development and Evaluation of an AI System Providing Feedback on "Quality of Performance" to Support Health and Activity |
| Date of disclosure of the study information | 2025/03/05 |
| Last modified on | 2026/03/31 21:01:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development and Evaluation of an AI System Providing Feedback on "Quality of Performance"
Acronym
AI System for Quality of Performance Feedback
Scientific Title
Development and Evaluation of an AI System Providing Feedback on "Quality of Performance" to Support Health and Activity
Scientific Title:Acronym
Development and Evaluation of an AI System for Quality of Performance
Region
| Japan |
Condition
Condition
Stroke, Parkinson's disease, frailty, musculoskeletal disorders, mobility limitations in older adults
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To measure and analyze the "quality of performance" of community-dwelling older adults and individuals requiring activity support in daily living, and to develop an AI-based feedback system to support their activity, prevent falls, and promote social participation.
Basic objectives2
Others
Basic objectives -Others
Changes in estimated gait dynamics and ground reaction forces, performance in activities of daily living, and neurophysiological function using AI system.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Kinematics, kinetics, and spatiotemporal parameters during performance (including estimation of ground reaction force)
Key secondary outcomes
physical function, balance, scores of performance, questionnaire, higher brain function, parameters using mixed reality and robotics
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Gait feedback using wearable sensors
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Community-dwelling older adults or individuals with movement disorders
Those who understand the research explanation and provide informed consent
Key exclusion criteria
Individuals unable to perform a 10m walk
Those with significant visual impairments affecting daily life
Those who are unable to understand research explanations and exercise instructions
Individuals deemed unsuitable by the researchers
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Kimihiko |
| Middle name | |
| Last name | Mori |
Organization
Kansai Medical University
Division name
Faculty of Rehabilitation
Zip code
573-1136
Address
18-89 Uyamahigashi-machi, Hirakata, Osaka 573-1136, Japan
TEL
072-856-2320
morikim@makino.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Kimihiko |
| Middle name | |
| Last name | Mori |
Organization
Kansai Medical University
Division name
Faculty of Rehabilitation
Zip code
573-1136
Address
18-89 Uyamahigashi-machi, Hirakata, Osaka 573-1136, Japan
TEL
0728562320
Homepage URL
morikim@makino.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Kimihiko Mori
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS), Moonshot Research & Development Program
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
the Ethics Committee of Kansai Medical University Hospital
Address
2-5-1 Shinmachi, Hirakata, Osaka 573-1010, Japan
Tel
0728040101
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
| 2025 | Year | 03 | Month | 05 | 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
| 2025 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2036 | 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
| 2025 | Year | 03 | Month | 05 | Day |
Last modified on
| 2026 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065212
