UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054906 |
|---|---|
| Receipt number | R000062676 |
| Scientific Title | Prediction of physical/cognitive function and daily living through gait analysis using smart insole |
| Date of disclosure of the study information | 2024/07/08 |
| Last modified on | 2024/07/08 10:49:27 |
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Basic information
Public title
Prediction of physical/cognitive function and daily living through gait analysis using smart insole
Acronym
Prediction of physical/cognitive function and daily living through gait analysis using smart insole
Scientific Title
Prediction of physical/cognitive function and daily living through gait analysis using smart insole
Scientific Title:Acronym
Prediction of physical/cognitive function and daily living through gait analysis using smart insole
Region
| Japan |
Condition
Condition
Healthy adult
Older people living in the community
Outpatients for department of rehabilitation or geriatrics & cognitive disorders
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the relationship between gait information obtained through the smart insole, i.e. gait speed, stride length, and plantar pressure distribute, and physical/cognitive functions as well as daily living conditions
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Walking abilty
(time-distance parameters, ground reaction force, foot pressure distribution, ROM)
Ability assessment(grip strength, MMT)
Frailty Assessment (MoCA-J, etc)
The living conditions questionnaire
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
[Healthy adult]
1.Consent to participate in this study
2.Participants whose general condition is stable and who are independent in daily living
[Older people living in the community]
[Outpatients for department of rehabilitation or geriatrics & cognitive disorders]
1.Consent to participate in this study
2.Participants whose general condition is stable
3.Participants who are able to walk without a walking aid
Key exclusion criteria
[Healthy adult]
1.Participants who have difficulty understanding instructions
2.Participants who are judged to be inappropriate by the researcher
[Older people living in the community]
[Outpatients for department of rehabilitation or geriatrics & cognitive disorders]
1.Participants who have difficulty understanding instructions
2.Participants who have leg pain and severe knee osteoarthritis
3.Participants who have extremely low overall endurance
4.Participants who have bone fragility
5.Participants who are judged to be inappropriate by the researcher
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University
Division name
Department of Rehabilitation Medicine, School of Medicine
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562-93-2167
cent-rsh@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University
Division name
Department of Rehabilitation Medicine, School of Medicine
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562-93-2167
Homepage URL
cent-rsh@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Fujita Health University
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
Tel
0562-93-2865
f-irb@fujita-hu.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
| 2024 | Year | 07 | Month | 08 | 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
| 2024 | Year | 04 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To examine the relationship between gait information obtained through the smart insole, i.e. gait speed, stride length, and plantar pressure distribute, and physical/cognitive functions as well as daily living conditions
Management information
Registered date
| 2024 | Year | 07 | Month | 08 | Day |
Last modified on
| 2024 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062676
