UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058668 |
|---|---|
| Receipt number | R000067088 |
| Scientific Title | Study on the timing of the onset of effects and carryover effects of toe pressure strength training |
| Date of disclosure of the study information | 2025/08/05 |
| Last modified on | 2025/08/01 16:37:55 |
* 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
Study on How and How Long the Effects of Toe Training Last
Acronym
Toe Pressure Strength Training Effects Study
Scientific Title
Study on the timing of the onset of effects and carryover effects of toe pressure strength training
Scientific Title:Acronym
Toe pressure strength training timing study
Region
| Japan |
Condition
Condition
older adults requiring long-term care
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the timing of the onset of effects and the presence of carryover effects after the intervention of toe pressure strength training, which has previously been shown to be effective.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
toe pressure strength
Timing: Week 1, Week 2, Week 3, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The intervention period is 12 weeks. Participants will be instructed to press a balance pad with their toes (5 seconds, 10 repetitions, 3 sets).
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Older adults requiring long-term care who use day rehabilitation services
Key exclusion criteria
1. Individuals with cognitive decline
2. Individuals who require assistance for walking
3. Individuals who use a wheelchair
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Taishir |
| Middle name | |
| Last name | Kamasaki |
Organization
Nishikyushu University
Division name
Faculty of Rehabilitation Sciences Department of Rehabilitation Sciences
Zip code
842-8585
Address
4490-9, Ozaki, Kanzaki, Saga
TEL
0952-37-9332
kamasakita@nisikyu-u.ac.jp
Public contact
Name of contact person
| 1st name | Taishiro |
| Middle name | |
| Last name | Kamasaki |
Organization
Nishikyushu University
Division name
Faculty of Rehabilitation Sciences Department of Rehabilitation Sciences
Zip code
842-8585
Address
4490-9, Ozaki, Kanzaki, Saga
TEL
0952-37-9332
Homepage URL
kamasakita@nisikyu-u.ac.jp
Sponsor or person
Institute
Nishikyushu University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Ito clinic day care rehabilitation ethics review committee
Address
90-1, Oaza Maetsu, Chikugo, Fukuoka
Tel
0942-65-6464
tai.pt.ft@gmail.com
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 | 08 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 20 | 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 | 08 | Month | 01 | Day |
Last modified on
| 2025 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067088
