UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058352 |
|---|---|
| Receipt number | R000066681 |
| Scientific Title | Controlled Comparative Study on the Safe Return to Driving following Volar Locking Plate Fixation for Distal Radius Fractures: Patients and Healthy Adults |
| Date of disclosure of the study information | 2025/07/04 |
| Last modified on | 2025/07/02 22:38:41 |
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Basic information
Public title
Study on the Safe Return to Driving after Surgery for Distal Radius Fractures: Comparison between Patients and Healthy Adults
Acronym
Safe Return to Drive after Distal Radius Fracture Surgery
Scientific Title
Controlled Comparative Study on the Safe Return to Driving following Volar Locking Plate Fixation for Distal Radius Fractures: Patients and Healthy Adults
Scientific Title:Acronym
Safe Return to Drive after Distal Radius Fracture Surgery
Region
| Japan |
Condition
Condition
Distal radius fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to determine the appropriate timing for safe return to driving and the required wrist function in patients following volar locking plating for distal radius fractures. Driving ability was quantitatively assessed over time using a driving simulator and compared with data from healthy individuals.
Basic objectives2
Others
Basic objectives -Others
This is an observational study aimed at determining the safe timing for resuming driving after distal radius fracture surgery by comparing the driving performance of patients with that of healthy adults over time using a driving simulator.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Results of the driving simulator task at 1, 2, 3, 4, 6 and 8 weeks after surgery
Key secondary outcomes
Pain at rest, during activity and steering operations; wrist range of motion; the Japanese version of the Patient-Rated Wrist Evaluation (PRWE-J); the Japanese version of Disability of the Arm, Shoulder, and Hand (DASH); and the Japanese version of the Michigan Hand Outcomes Questionnaire (MHQ-J)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Individuals who have provided informed consent
2) Individuals who possess a valid driver's license and drive regularly
Key exclusion criteria
1) Patients with multiple fractures (in the patient group)
2) Individuals with a history of upper limb trauma or central nervous system disorders
3) Individuals who are unable to understand the study content due to dementia or other cognitive impairments
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Rikiya |
| Middle name | |
| Last name | SHIRATO |
Organization
Hokkaido Bunkyo University
Division name
Department of Rehabilitation, Faculty of Healthcare and Science
Zip code
061-1449
Address
196-1 Kogane-chuo, Eniwa 061-1449, Japan
TEL
0123-34-0198
rshirato@do-bunkyodai.ac.jp
Public contact
Name of contact person
| 1st name | Rikiya |
| Middle name | |
| Last name | SHIRATO |
Organization
Hokkaido Bunkyo University
Division name
Department of Rehabilitation, Faculty of Healthcare and Science
Zip code
061-1449
Address
196-1 Kogane-chuo, Eniwa 061-1449, Japan
TEL
0123-34-0198
Homepage URL
rshirato@do-bunkyodai.ac.jp
Sponsor or person
Institute
Hokkaido Bunkyo University
Institute
Department
Personal name
Funding Source
Organization
ZENKYOREN (National Mutual Insurance Federation of Agricultural Cooperatives)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Saiseikai Oraru Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido Bunkyo University
Address
196-1 Kogane-chuo, Eniwa 061-1449, Japan
Tel
+81(0)123-34-0198
daigakuhyouka_ir@do-bunkyodai.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
北海道文教大学（北海道）、済生会小樽病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 04 | 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 | 07 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 28 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study aimed to determine the appropriate timing for safe return to driving and the required wrist function in patients following volar locking plating for distal radius fractures. Driving ability was quantitatively assessed over time using a driving simulator and compared with data from healthy individuals.
Management information
Registered date
| 2025 | Year | 07 | Month | 02 | Day |
Last modified on
| 2025 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066681
