UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058364 |
|---|---|
| Receipt number | R000066653 |
| Scientific Title | Examining the Effects of Foot Sensory Stimulation Using Rubber Bands on Physical Function and Exercise Performance |
| Date of disclosure of the study information | 2025/09/25 |
| Last modified on | 2025/07/03 16:50:24 |
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Basic information
Public title
Examining the Effects of Foot Sensory Stimulation Using Rubber Bands on Physical Function and Exercise Performance
Acronym
Intervention experiment on physical activity using rubber bands
Scientific Title
Examining the Effects of Foot Sensory Stimulation Using Rubber Bands on Physical Function and Exercise Performance
Scientific Title:Acronym
Intervention experiment on physical activity using rubber bands
Region
| Japan |
Condition
Condition
Dysfunction of the muscles around the foot
Classification by specialty
| Orthopedics | Rehabilitation medicine | Adult |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the effectiveness of rubber band-worn exercise and exercise interventions on improving exercise performance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rubber band exercise and exercise intervention will be evaluated immediately after the intervention for immediate effects, and at 4, 8, and 12 weeks after the intervention begins.
The evaluation items will be mobility, muscle strength and power, and coordination of each body part. Exercise performance will be evaluated in terms of performance specific to each athletic activity (e.g., swimming time, stroke frequency, and kick frequency in the case of swimming).
Key secondary outcomes
Assessment of motor performance will include measurement of vertical jump, standing long jump, ball throw, grip strength, upper body raising, and long body forward bending.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
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
The intervention period for foot stimulation with rubber bands will be completed once a day if the immediate post-intervention effect is to be tested. To test the long-term effects of the intervention, training will be conducted for 12 weeks, wearing the rubber bands during the specified exercises or workouts. The duration will depend on the exercise content, but will be approximately 15 to 30 minutes. This will be done 5 times a week.
Interventions/Control_2
For the intervention period without rubber bands, if the immediate post-intervention effect is to be tested, the measured items will be tested without intervention. To test the long-term effects of the intervention, participants will train for 12 weeks without wearing rubber bands during the specified exercises or workouts. The duration will depend on the exercise content, but will be approximately 15 to 30 minutes. This will be performed five times a week.
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
| 8 | years-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Exercise or exercise intervention, with a minimum of 5 exercise routines per week for at least 1 year.
Key exclusion criteria
Must have orthopedic disease in the foot or lower extremity, or a history of lower extremity surgery.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Takao |
| Middle name | |
| Last name | Mise |
Organization
Niigata university health and welfare
Division name
Department of Health and Sports
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata, JAPAN
TEL
0252574690
mise@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Mise |
Organization
Niigata university health and welfare
Division name
Department of Health and Sports
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata, JAPAN
TEL
0252574690
Homepage URL
mise@nuhw.ac.jp
Sponsor or person
Institute
Niigata university health and welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata university health and welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japan sports agency
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata university health and welfare
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata, JAPAN
Tel
0252574690
mise@nuhw.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
| 2025 | Year | 09 | 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
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 | 06 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 11 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2025 | Year | 07 | Month | 03 | Day |
Last modified on
| 2025 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066653
