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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000019770
Receipt No. R000022832
Scientific Title Driving ability of cycling wheelchair in Parkinson's disease
Date of disclosure of the study information 2015/11/12
Last modified on 2015/11/26

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Basic information
Public title Driving ability of cycling wheelchair in Parkinson's disease
Acronym Cycling wheelchair in Parkinson's disease
Scientific Title Driving ability of cycling wheelchair in Parkinson's disease
Scientific Title:Acronym Cycling wheelchair in Parkinson's disease
Region
Japan

Condition
Condition Parkinson's disease
Classification by specialty
Neurology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the difference of driving ability between cycling wheelchairs and standard wheelchairs in patients with Parkinson's disease
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Phase I

Assessment
Primary outcomes Driving speed
Key secondary outcomes Heart rate and blood pressure

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Device,equipment
Interventions/Control_1 Cycling wheelchair
Interventions/Control_2 Standard wheelchair
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
60 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria 1. Hoehn and Yahr stage<5
2. can understand verbal instructions
Key exclusion criteria 1. History of other neurological disorders, severe orthopedic disease and cardiovascular disease
2.Presence of cardiac pacemaker
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yohei Okada
Organization Kio University
Division name Department of Physical Therapy, Faculty of health Sciences
Zip code
Address 4-2-2 umami-naka koryo-cho, kitakatsuragi-gun, Nara, 635-0832 JAPAN
TEL +81-745-54-1601
Email y.okada@kio.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yohei Okada
Organization Kio University
Division name Department of Physical Therapy, Faculty of Health Science
Zip code
Address 4-2-2 umami-naka koryo-cho, kitakatsuragi-gun, Nara, 635-0832 JAPAN
TEL +81-745-54-1601
Homepage URL
Email y.okada@kio.ac.jp

Sponsor
Institute Kio University
Institute
Department

Funding Source
Organization Kio University
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
Address
Tel
Email

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
2015 Year 11 Month 12 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
2015 Year 11 Month 12 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 15 Day
Last follow-up date
2015 Year 12 Month 31 Day
Date of closure to data entry
2016 Year 01 Month 15 Day
Date trial data considered complete
2016 Year 02 Month 01 Day
Date analysis concluded
2016 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 11 Month 12 Day
Last modified on
2015 Year 11 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022832

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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