UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043343 |
|---|---|
| Receipt number | R000049487 |
| Scientific Title | Quantitative assessment of distal radioulnar joint instability and intervention effects |
| Date of disclosure of the study information | 2021/02/16 |
| Last modified on | 2022/10/29 21:16:00 |
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Basic information
Public title
Quantitative assessment of distal radioulnar joint instability and intervention effects
Acronym
Quantitative assessment of distal radioulnar joint instability and intervention effects
Scientific Title
Quantitative assessment of distal radioulnar joint instability and intervention effects
Scientific Title:Acronym
Quantitative assessment of distal radioulnar joint instability and intervention effects
Region
| Japan |
Condition
Condition
Orthopedic disease with distal radial joint instability, wheelchair users, healthy subjects
Classification by specialty
| Surgery in general | Orthopedics | Rehabilitation medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To quantitatively assess distal radioulnar joint instability using an ultrasound system and an cyclic compression device and to investigate its relationship to clinical symptoms. To evaluate the safety and efficacy of rehabilitation interventions.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Distal radioulnar joint instability
Upper extremity function (muscle strength, range of motion, questionnaires, etc.)
Key secondary outcomes
Basic Information
Medical Information
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
We quantitatively assess distal radioulnar joint instability (once on each side).
Detailed methodology
DRUJ instability will be assessed by Force-monitor ultrasonography. Grip strength, range of motion (ROM), circumference and, interview using Quick DASH participants' daily activities, work, and any difficulties or pain experienced during sports, will be assessed. The Force-monitor ultrasonography system applies cyclic compression to the DRUJ with an ultrasound probe to measure radioulnar displacement and applied compression force. Apply cyclic compression with a compression depth of 3 mm and a compression rate of 1.5 Hz.
Safety considerations
Since the depth of compression is 3 mm, only a slight force is applied, and there is little risk of inducing pain. If any discomfort or pain is felt, the apparatus is quickly stopped by pressing the stop button.
Follow-up
We will conduct follow-up surveys on an annual basis.
Expected outcomes of the study
Intervention for DRUJ instability may be related to TFCC injury prevention in wheelchair basketball athletes.
Dissemination of results and publication policy
Measurement results will be fed back to participants.
The research results will be published in an integrated form so that individuals cannot be identified.
Interventions/Control_2
We provide rehabilitation for distal radioulnar joint instability (teaching activities of daily living and taping).
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with distal radioulnar joint instability, or healthy individuals, or wheelchair users
Problems anticipated
Shortage of the expected target population within the time frame is expected.
Solution: Switch to a longitudinal survey by identifying trends from the target population recruited in the first year.
Key exclusion criteria
Patients with distal radioulnar joint instability.
(1) Patients with acute deterioration of the condition.
(2) Decline in cognitive function.
(3) The patient who judged that the medical doctor was inappropriate.
Healthy individuals:
(1) Persons with no disease in both upper limbs.
Wheelchair users:
(1) Patients with acute deterioration of the condition.
(2) Decline in cognitive function.
(3) The patient who judged that the medical doctor was inappropriate.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | YUINE |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Department of Occupational Therapy
Zip code
300-0394
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki
TEL
029-840-2220
yuinehi@ipu.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | YUINE |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Department of Occupational Therapy
Zip code
300-0394
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki
TEL
029-840-2220
Homepage URL
yuinehi@ipu.ac.jp
Sponsor or person
Institute
Ibaraki Prefectural University of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Ibaraki Prefectural University of Health Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo Medical University Ibaraki Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ibaraki Prefectural University of Health Sciences Institutional Review Board
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki
Tel
029-840-4000
ishiika@ipu.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
Ibaraki Prefectural University of Health Sciences Hospital（Ibaraki）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 16 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 16 | 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
Rationale & background information
Preventing triangular fibrocartilage complex (TFCC) injuries and reducing the risk of recurrence are essential issues for wheelchair basketball athletes. Distal radioulnar joint (DRUJ) stability may be associated with hand function and may be related to TFCC injury prevention in wheelchair basketball athletes. Although DRUJ instability can be quantitatively assessed using ultrasonography, the incidence of DRUJ instability in wheelchair basketball athletes and its relationship to hand function is unclear.
Data Management
We will keep the data locked in a locker with a key.
Statistical Analysis
A Cross-sectional Survey: group comparisons between TFCC-injured and non-injured groups and correlation analysis of hand function
Intervention study: group comparison between intervention group and normal group
The statistical significance level will be less than 5%.
Quality assurance
We will keep (university hospital medical information-clinical trials registry) UMIN-TR informed of the progress of our research in response to periodic confirmations.
Project management
HY will contribute to the study concept, design, data acquisition and analysis. HM, YS, and KT will contribute to the study concept, design, data acquisition and analysis. YY and HS will contribute to the study concept, data interpretation. NI and TY will contribute to the data acquisition and interpretation.
Ethics approval and consent to participate
This study was approved by the Institutional Review Board of Ibaraki Prefectural University of Health Sciences (No. e306)
In accordance with the Declaration of Helsinki, the purpose, methods, anticipated benefits and potential risks, and other relevant matters of the research will be explained to all participants and written informed consent obtained.
Management information
Registered date
| 2021 | Year | 02 | Month | 16 | Day |
Last modified on
| 2022 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049487
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