UMIN-CTR Clinical Trial

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
Email	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
Email	m-azami@jhsu.ac.jp

Sponsor
Institute	Japan University of Health Sciences
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049692