UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049190 |
|---|---|
| Receipt number | R000056031 |
| Scientific Title | Investigation of factors influencing lower leg internal/external rotation movements during driving a car. |
| Date of disclosure of the study information | 2022/10/11 |
| Last modified on | 2023/04/13 16:23:38 |
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Basic information
Public title
Investigation of factors influencing lower leg movements during driving a car.
Acronym
Investigation of factors influencing lower leg movements during driving a car.
Scientific Title
Investigation of factors influencing lower leg internal/external rotation movements during driving a car.
Scientific Title:Acronym
Investigation of factors influencing lower leg internal/external rotation movements during driving a car.
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine how lower leg internal/external rotation movements act in pedal operation for driving a car and the factors that affect lower leg internal/external rotation movements.
Basic objectives2
Others
Basic objectives -Others
Determine how age, gender, and driving history affect pedal operation.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Angular change of lower leg internal/external rotation movement
Key secondary outcomes
Reaction time
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
Preparation
Sit in a comfortable seat position
Two goniometers are to be worn.
(1) Anterior surface of tibia and third metatarsal bone
(2) Superior anterior iliac spine and front of thigh
Calibration
Measure angles at 0 degrees, 10 degrees of internal rotation, and 10 degrees of external rotation.
Measurement
Selective reaction speed test and comprehensive study using a drive simulator
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adults with a driver's license
Key exclusion criteria
Those who cannot maintain the sitting posture for 30 minutes.
Those who have difficulty operating the simulator due to screen sickness.
Those who cannot understand our instructions.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Kanata |
Organization
Hyogo Medical University Sasayama Medical Center
Division name
Department of Rehabilitation Medicine
Zip code
669-2321
Address
Kurooka 5, Tanbasasayama city, Hyogo, Japan
TEL
0795521181
ym_kanata611@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Kanata |
Organization
Hyogo Medical University Sasayama Medical Center
Division name
Department of Rehabilitation Medicine
Zip code
669-2321
Address
Kurooka 5, Tanbasasayama city, Hyogo, Japan
TEL
0795521181
Homepage URL
ym_kanata611@yahoo.co.jp
Sponsor or person
Institute
Hyogo Medical University Sasayama Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
Hyogo Medical University Sasayama Medical Center
Address
Kurooka 5, Tanbasasayama city, Hyogo, Japan
Tel
0795521181
ym_kanata611@yahoo.co.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
| 2022 | Year | 10 | Month | 11 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2024 | 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
| 2022 | Year | 10 | Month | 11 | Day |
Last modified on
| 2023 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056031
