UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062977 |
|---|---|
| Receipt number | R000072106 |
| Scientific Title | Effects of Short-Term Immobilization on Motor Imagery and Bilateral Symmetry of Upper Limb Activity: Implications for the Mechanisms of Secondary Fracture |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/09/18 14:06:12 |
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Basic information
Public title
Effects of Short-Term Upper Limb Immobilization on Motor Imagery and Upper Limb Activity
Acronym
Short-Term Upper Limb Immobilization Study
Scientific Title
Effects of Short-Term Immobilization on Motor Imagery and Bilateral Symmetry of Upper Limb Activity: Implications for the Mechanisms of Secondary Fracture
Scientific Title:Acronym
Short-Term Immobilization, Motor Imagery, and Upper Limb Activity Study
Region
| Japan |
Condition
Condition
Secondary fracture after distal radius fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Distal radius fracture, a common initial fragility fracture, is associated with a high risk of subsequent fractures, including hip fractures. Based on our previous findings, changes in bilateral symmetry of upper-limb activity and dynamic balance function have been identified as potential factors contributing to secondary fracture risk. Previous studies have also reported that short-term immobilization may reduce muscle contraction efficiency and motor imagery ability. However, the causal relationships among these factors remain unclear. This study aims to investigate the effects of short-term upper-limb immobilization on these factors and thereby elucidate part of the mechanism underlying secondary fractures. The findings of this study are expected to contribute to the development of novel intervention strategies.
Basic objectives2
Others
Basic objectives -Others
To investigate the effects of short-term upper limb immobilization on motor imagery, bilateral symmetry of upper limb activity, and dynamic balance, and to explore the mechanisms underlying secondary fractures.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in bilateral symmetry of upper limb activity and dynamic balance function.
Key secondary outcomes
Coefficient of variation during the pinch-force maintenance task; maximal grip strength; median frequency and peak amplitude of wrist muscle surface electromyography during maximal grip exertion; reaction time for left-right discrimination in the Hand Mental Rotation Test; completion times for the 8-Foot Up-and-Go Test (8FtG) and Four Square Step Test (FSST); and scores for each item of the Kinesthetic and Visual Imagery Questionnaire (KVIQ). These outcomes will be assessed before and after immobilization.
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
| Other |
Interventions/Control_1
24-hour immobilization of the non-dominant upper limb
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adults aged 18 years or older and younger than 50 years who are determined to be right-handed based on a laterality quotient of 90% or higher on the Edinburgh Handedness Inventory. Participants must have no history of orthopedic or central nervous system disorders that could affect upper limb function, motor imagery, or balance function, and must provide written informed consent to participate in the study.
Key exclusion criteria
Participants who have been diagnosed with osteoporosis
Participants with a bone mineral density of less than 80% of the young adult mean (YAM)
Participants with underlying diseases that may cause bone fragility
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Terufumi |
| Middle name | |
| Last name | Iitsuka |
Organization
Nagoya city university
Division name
Medical school of Department Health Science, Major in Rehabilitation Science
Zip code
4658650
Address
2-1501 Sekobo, Meito-ku, Nagoya, Aichi
TEL
+81-52-784-7163
iitsuka@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Terufumi |
| Middle name | |
| Last name | Iitsuka |
Organization
Nagoya city university
Division name
Medical school of Department Health Science, Major in Rehabilitation Science
Zip code
4658650
Address
2-1501 Sekobo, Meito-ku, Nagoya, Aichi
TEL
+81-52-784-7163
Homepage URL
iitsuka@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
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
Institutional Review Board of Nagoya City University
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi
Tel
0528538348
rinshou-kenkyu@med.nagoya-cu.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
| 2026 | Year | 10 | Month | 01 | 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
| 2026 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2029 | 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
| 2026 | Year | 09 | Month | 18 | Day |
Last modified on
| 2026 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072106
