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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000023678
Receipt No. R000023853
Scientific Title The investigation of the safety and efficiency of desk work using automatic wheel chair with assistance for standing in the person with a disability of lower extremity
Date of disclosure of the study information 2016/08/18
Last modified on 2016/08/18

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Basic information
Public title The investigation of the safety and efficiency of desk work using automatic wheel chair with assistance for standing in the person with a disability of lower extremity
Acronym The investigation of the safety and efficiency using automatic wheel chair with assistance for standing
Scientific Title The investigation of the safety and efficiency of desk work using automatic wheel chair with assistance for standing in the person with a disability of lower extremity
Scientific Title:Acronym The investigation of the safety and efficiency using automatic wheel chair with assistance for standing
Region
Japan

Condition
Condition Person with a disability of lower extremity
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate of the safety in transfer, standing and locomotive and efficiency of desk work using automatic wheel chair with assistance for standing in the person with a disability of lower extremity
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Electromyography
Key secondary outcomes blood presure
heart rate
range of motion
efficiency of desk work

Base
Study type Others,meta-analysis etc

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
13 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria 1)who are aged 13 to 75 years olds at informed consent
2)who could not walking due to paralysis of lower extremity or lower muscle strength
3)who are independent and working using wheel chair

Key exclusion criteria 1)who could not be sitting
2)who had a severe dementia and those with mental retardation
3)who had a orthostatic hypotension systolic blood pressure 30mmHg
4)who had a history of myocardial infarction
5)who had a inflammatory joint disease
6)who had a pressure ulcer in the sciatic
7)who had a dizziness and nausea of the inner ear nervous system
8)who had not person who can consent the entry of study instead of the subjects
9)who had a history of stroke difficult to sitting due to severe paralysis hoffer classification grade 2 or 3 or the grade of Br-stage of the lower extremities is 1
10)who are pregnancy
11)who are determined to be not inappropriate as a subjects in this study by investigators

Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiromi Matsumoto
Organization Tottori University Hospital
Division name Rehabilitation Division
Zip code
Address Nishicho 36-1, Yonago, Tottori
TEL 0859-38-6862
Email h.matsumoto@med.tottori-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiromi Matsumoto
Organization Tottori University Hospital
Division name Rehabilitation Division
Zip code
Address Nishicho 36-1, Yonago, Tottori
TEL 0859-38-6862
Homepage URL
Email h.matsumoto@med.tottori-u.ac.jp

Sponsor
Institute Tottori University Hospital
Institute
Department

Funding Source
Organization Tottori University Hospital
Organization
Division
Category of Funding Organization Self funding
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
2016 Year 08 Month 18 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
Date of protocol fixation
2016 Year 03 Month 29 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2016 Year 08 Month 18 Day
Last modified on
2016 Year 08 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023853

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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