UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Hiromi Matsumoto
Organization	Tottori University Hospital
Division name	Rehabilitation Division
Address	Nishicho 36-1, Yonago, Tottori
TEL	0859-38-6862
Email	h.matsumoto@med.tottori-u.ac.jp

Public contact
Name of contact person	Hiromi Matsumoto
Organization	Tottori University Hospital
Division name	Rehabilitation Division
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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 03 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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