UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043522 |
|---|---|
| Receipt number | R000049692 |
| Scientific Title | Impact of cognitive function on Mobility scooter driving skills. A cross sectional study |
| Date of disclosure of the study information | 2021/03/15 |
| Last modified on | 2022/04/28 14:31:37 |
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Basic information
Public title
Impact of cognitive function on Mobility scooter driving skills. A cross sectional study
Acronym
Impact of cognitive function on Mobility scooter driving skills. A cross sectional study
Scientific Title
Impact of cognitive function on Mobility scooter driving skills. A cross sectional study
Scientific Title:Acronym
Impact of cognitive function on Mobility scooter driving skills. A cross sectional study
Region
| Japan |
Condition
Condition
General elderly and MCI elderly
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarify how cognitive function affects Mobility Scooter driving skills
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Wheelchair Skills Test
Key secondary outcomes
Accident History
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
| 65 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Use MS at least once a week
Age 65 years or older at the time of the survey
Difficulty in walking more than 50 m without the use of a walking aid
Key exclusion criteria
Unable to obtain written consent
Has significant cognitive impairment that makes it difficult to conduct the survey
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Azami |
Organization
Japan University of Health Sciences
Division name
Department of Physical Therapy
Zip code
340-0145
Address
2-555, Hirasuka, Satte-City, Saitama 340-0145, Japan
TEL
0480-48-5806
m-azami@jhsu.ac.jp
Public contact
Name of contact person
| 1st name | Masato |
| Middle name | |
| Last name | Azami |
Organization
Japan University of Health Sciences
Division name
Department of Physical Therapy
Zip code
340-0145
Address
2-555, Hirasuka, Satte-City, Saitama 340-0145, Japan
TEL
0480-48-5806
Homepage URL
m-azami@jhsu.ac.jp
Sponsor or person
Institute
Japan University of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Japan University of Health Sciences
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
Japan University of Health Sciences
Address
2-555, Hirasuka, Satte-City, Saitama 340-0145, Japan
Tel
0480-48-5806
m-azami@jhsu.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
| 2021 | Year | 03 | Month | 15 | 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
| Delay expected |
Results Delay Reason
Due to the delay in recruiting participants by Corona.
Date of the first journal publication of results
| 2022 | Year | 10 | Month | 31 | Day |
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
| 2020 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Measurements are performed by two physical therapists.
The measurement time will be 90 minutes per person.
No follow-up survey will be conducted.
Management information
Registered date
| 2021 | Year | 03 | Month | 04 | Day |
Last modified on
| 2022 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049692
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
