UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054693 |
|---|---|
| Receipt number | R000062502 |
| Scientific Title | Verification of the usefulness of shock-absorbing flooring materials for the older people and the physically handicapped people. |
| Date of disclosure of the study information | 2024/06/18 |
| Last modified on | 2025/06/27 09:28:19 |
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Basic information
Public title
Verification of the usefulness of shock-absorbing flooring materials for the older people and the physically handicapped people.
Acronym
Verification of the usefulness of shock-absorbing flooring materials for the older people and the physically handicapped people.
Scientific Title
Verification of the usefulness of shock-absorbing flooring materials for the older people and the physically handicapped people.
Scientific Title:Acronym
Verification of the usefulness of shock-absorbing flooring materials for the older people and the physically handicapped people.
Region
| Japan |
Condition
Condition
Older people living in the community
Patients for rehabilitation
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect on gait and balance of the older people and the physically handicapped people, including a comparison between existing products and shock-absorbing flooring materials
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gait performance evaluation
Balance performance evaluation
Key secondary outcomes
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
Floor conditions
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Both the older people living in the community and rehabilitation patients
1.Consent to participate in this study
2.Participants whose general condition is stable and who are independent in daily living
3.Participants who are stable in gait and standing with closed eyes on a normal floor condition
Key exclusion criteria
Both the older people living in the community and rehabilitation patients
1.Participants who have difficulty understanding instructions
2.Participants with pain in the lower extremities on a daily basis
3.Participants with extremely low general endurance
4.Participants who are judged to be inappropriate by the researcher
Target sample size
40
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 | Hikaru |
| Middle name | |
| Last name | Kondo |
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
0562-93-9720
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 | 06 | Month | 18 | Day |
Related information
URL releasing protocol
Results publication procedure in progress
Publication of results
Unpublished
Result
URL related to results and publications
Results publication procedure in progress
Number of participants that the trial has enrolled
19
Results
Results publication procedure in progress
Results date posted
| 2025 | Year | 06 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Results publication procedure in progress
Participant flow
Results publication procedure in progress
Adverse events
Results publication procedure in progress
Outcome measures
Results publication procedure in progress
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | 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
| 2024 | Year | 06 | Month | 18 | Day |
Last modified on
| 2025 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062502
