UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023678 |
|---|---|
| Receipt number | 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 22:14:01 |
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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
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
h.matsumoto@med.tottori-u.ac.jp
Sponsor or person
Institute
Tottori University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023853
| 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 |
