UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058240 |
|---|---|
| Receipt number | R000066580 |
| Scientific Title | Normal dynamic joint range of motion of the thumb carpometacarpal joint in activities of daily living |
| Date of disclosure of the study information | 2025/06/21 |
| Last modified on | 2025/06/20 16:20:55 |
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Basic information
Public title
Normal dynamic joint range of motion of the thumb carpometacarpal joint in activities of daily living
Acronym
Normal dynamic joint range of motion of the thumb carpometacarpal joint in activities of daily living
Scientific Title
Normal dynamic joint range of motion of the thumb carpometacarpal joint in activities of daily living
Scientific Title:Acronym
Normal dynamic joint range of motion of the thumb carpometacarpal joint in activities of daily living
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish preliminary normal values for three-dimensional thumb CM joint motion during standardized activities of daily living in healthy young adults.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Articulation angle
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Manipulation of goods in daily life
Interventions/Control_2
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 adults with no history of neuromuscular or orthopedic disease
Key exclusion criteria
Hand dysfunction due to neuromuscular and orthopedic diseases
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Chihiro |
| Middle name | |
| Last name | FUJIME |
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
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
0252574497
Homepage URL
fujime@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
chihiro fujime
Funding Source
Organization
Niigata University of Health and Welfare
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
0252574497
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
新潟県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 21 | 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 | 20 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | 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 | 06 | Month | 20 | Day |
Last modified on
| 2025 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066580
