UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060605 |
|---|---|
| Receipt number | R000069320 |
| Scientific Title | Evaluation of the intervention effects on the rate of force development of toe pressure strength in the standing position |
| Date of disclosure of the study information | 2026/02/06 |
| Last modified on | 2026/02/06 16:23:01 |
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Basic information
Public title
A study to examine the effects of toe pressure strength training on the ability to generate toe force quickly
Acronym
Toe Training RFD Study
Scientific Title
Evaluation of the intervention effects on the rate of force development of toe pressure strength in the standing position
Scientific Title:Acronym
Intervention Effects on the RFD of Toe Pressure Strength in the Standing Position
Region
| Japan |
Condition
Condition
older adults requiring long-term care
Classification by specialty
| Geriatrics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the intervention effect on RFD of toe pressure strength.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
RFD of toe pressure strength in the standing position
Key secondary outcomes
TUG, Gait speed (noemal, max)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Participants will perform an exercise on a balance pad, pressing their toes down against the floor as quickly as possible. Each repetition lasts 5 seconds; 10 repetitions constitute one set, and three sets are performed per session. The intervention will be carried out for 12 weeks.
Interventions/Control_2
The control group will receive standard rehabilitation only.
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
Eligible participants will be older adults certified as requiring long-term care and currently using outpatient rehabilitation services, who are able to walk independently and provide written informed consent.
Key exclusion criteria
Individuals diagnosed with dementia; individuals with psychiatric disorders; and individuals who use a wheelchair for activities of daily living.
Target sample size
30
Research contact person
Name of lead principal investigator
| 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
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
Other
Organization
Division
Category of Funding Organization
Non profit foundation
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
daycare.serori2022@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
| 2026 | Year | 02 | Month | 06 | 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
| 2026 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 02 | Month | 06 | Day |
Last modified on
| 2026 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069320
