UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060094 |
|---|---|
| Receipt number | R000067961 |
| Scientific Title | Development of Effective Muscle Reconditioning Methods for Joint-Supporting Muscles |
| Date of disclosure of the study information | 2025/12/17 |
| Last modified on | 2025/12/16 09:54:02 |
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Basic information
Public title
Development of Effective Muscle Reconditioning Methods for Joint-Supporting Muscles
Acronym
Development of Effective Muscle Reconditioning Methods for Joint-Supporting Muscles
Scientific Title
Development of Effective Muscle Reconditioning Methods for Joint-Supporting Muscles
Scientific Title:Acronym
Development of Effective Muscle Reconditioning Methods for Joint-Supporting Muscles
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct muscle re-education training targeting the inner muscles of the elbow joint and to verify its effects in combination with transcranial direct current stimulation (tDCS).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Electromyography
Motor Evoked Potential
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Neuromuscular re-education training only, five days per week for three weeks.
Interventions/Control_2
Transcranial direct current stimulation (tDCS) combined with training, five days per week for three weeks.
Interventions/Control_3
Dual-site tDCS combined with training, five days per week for three weeks.
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
| 23 | years-old | <= |
Age-upper limit
| 55 | years-old | > |
Gender
Male
Key inclusion criteria
Healthy volunteers
Key exclusion criteria
Any pre-existing orthopedic or neuromuscular disease
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hirokatsu |
| Middle name | |
| Last name | Iseki |
Organization
Niigata University of Health and Welfare
Division name
Depertoment of Occupational Therapy
Zip code
9503198
Address
1398, Shimami-cho, Kita-ku, Niigatashi, Niigata
TEL
0252574497
hirokatsu-iseki@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Hirokatsu |
| Middle name | |
| Last name | Iseki |
Organization
Niigata University of Health and Welfare
Division name
Depertment of Occupational Therapy
Zip code
9503198
Address
1398, shimamicho, Kita-ku, Niigatashi, Niigata
TEL
0252574497
Homepage URL
hirokatsu-iseki@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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 Welfare
Address
1398, shimamicho, Kita-ku, Niigatashi, Niigata
Tel
025-257-4455
rinri@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 | 12 | Month | 17 | 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 | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | 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 | 12 | Month | 16 | Day |
Last modified on
| 2025 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067961
