UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057545 |
|---|---|
| Receipt number | R000065748 |
| Scientific Title | Effects of the illusion of vibratory stimulation of the thenar muscles on pinch force regulation |
| Date of disclosure of the study information | 2025/04/20 |
| Last modified on | 2025/04/07 20:38:55 |
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Basic information
Public title
Effects of the illusion of vibratory stimulation of the thenar muscles on pinch force regulation
Acronym
Effects of the illusion of vibratory stimulation of the thenar muscles on pinch force regulation
Scientific Title
Effects of the illusion of vibratory stimulation of the thenar muscles on pinch force regulation
Scientific Title:Acronym
Effects of the illusion of vibratory stimulation of the thenar muscles on pinch force regulation
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we selectively induce the illusion of proprioceptive sensation by applying vibratory stimulation to the thumb ball muscles of healthy adults, and examine the effect on pinch force regulation.
Basic objectives2
Others
Basic objectives -Others
This is an important finding that provides evidence for the direct involvement of proprioceptive sensation in pinch force regulation.In addition, by comparing the compensatory effect of FPL activity in the flexed and extended positions of the thumb IP joint, a hypothesis is proposed for the high complication rate of carpal tunnel syndrome and thumb CM arthropathy.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Thunmb proprioception test, pinch force adjustment test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Vibration Stimulus 30sec, total 4
Interventions/Control_2
Non vibration stimulus
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
| 18 | years-old | <= |
Age-upper limit
| 45 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy subjects with no history of orthopedic or neuromuscular disease
Key exclusion criteria
Pre-existing orthopedic and neuromuscular diseases
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Chihiro |
| Middle name | |
| Last name | Fujime |
Organization
Niigata university of health and walefare
Division name
Depertoment of Occupational Therapy
Zip code
950-3198
Address
1398, Shimami-cho, Kita-ku, Niigatashi, Niigata
TEL
0252574496
fujime@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Chihiro |
| Middle name | |
| Last name | Fujime |
Organization
Niigata University of Health and Welfare
Division name
Depertment of Occupational Therapy
Zip code
950-3198
Address
1398, shimamicho, Kita-ku, Niigatashi, Niigata
TEL
0252574496
Homepage URL
fujime@nuhw.ac.jp
Sponsor or person
Institute
Niigata university of health and walefare
Institute
Department
Personal name
Funding Source
Organization
Niigata university of health and walefare
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
Niigata University of Health and Walefer
Address
1398, Shimami-cho, kitaku, niigata-shi, niigata
Tel
0252574496
fujime@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 | 04 | Month | 20 | 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 | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 01 | 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 | 04 | Month | 07 | Day |
Last modified on
| 2025 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065748
