UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057388 |
|---|---|
| Receipt number | R000065573 |
| Scientific Title | The effect of intervention on toe pressure strength on the physical function of long-term care-requiring older adults: A double-blind randomized controlled trial |
| Date of disclosure of the study information | 2025/03/25 |
| Last modified on | 2025/09/22 09:08:51 |
* 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
Research on toe muscle training to improve the physical functions of older adults requiring long-term care
Acronym
Research on toe muscle training
Scientific Title
The effect of intervention on toe pressure strength on the physical function of long-term care-requiring older adults: A double-blind randomized controlled trial
Scientific Title:Acronym
Verification of the intervention effect on toe pressure strength
Region
| Japan |
Condition
Condition
Older adults requiring long-term care
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effects of interventions on toe pressure strength in the standing position in older adults requiring long-term care.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
toe pressure strength in the standing position (Before and 12 weeks after the intervention)
Key secondary outcomes
TUG, Normal walking speed, Maximum walking speed, FTSST, Handgrip strength, Side-by-side, Semi-tandem, Tandem
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Participants in the intervention group underwent toe pressure strength training in addition to the usual rehabilitation carried out in the control group. 12-week intervention. 10 repetitions x 3 sets (5 seconds per repetition) of pressure on the balance mat with the toes. For toe pressure strength training, we used balance pad (AMB-ELITE, AIREX, Switzerland).
Interventions/Control_2
Participants in the control group received 20 minutes of individual rehabilitation a day from a physical therapist or occupational therapist.
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
In this study, we registered older adults requiring long-term care who were using day care rehabilitation. The selection criteria for participants were as follows: participants who had received a long-term care insurance certification, participants who used day care rehabilitation, and participants who were 65 years of age or older.
Key exclusion criteria
The exclusion criteria were participants with a dementia diagnosis, participants with a mental disorder diagnosis, and participants who need help to stand up or walk.
Target sample size
40
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
tai.pt.ft@gmail.com
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
tai.pt.ft@gmail.com
Sponsor or person
Institute
Nishikyushu University
Institute
Department
Personal name
Kamasaki Taishiro
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 | 03 | Month | 25 | 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
36
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
Completed
Date of protocol fixation
| 2024 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2025 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 24 | Day |
Last modified on
| 2025 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065573
