UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022874 |
|---|---|
| Receipt number | R000026304 |
| Scientific Title | Safety and feasibility evaluation of the novel arm motion measurement device evaluatio for central nerve disorder patients |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2016/06/24 16:31:31 |
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Basic information
Public title
Safety and feasibility evaluation of the novel arm motion measurement device evaluatio for central nerve disorder patients
Acronym
Evaluation of the novel upper arm motion measurement device
Scientific Title
Safety and feasibility evaluation of the novel arm motion measurement device evaluatio for central nerve disorder patients
Scientific Title:Acronym
Evaluation of the novel upper arm motion measurement device
Region
| Japan |
Condition
Condition
dysfunction of voluntary movement
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
feasibility, safety
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
/adverse reaction
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
/Single time intervention
/Repeat up to 200 times of arm reach movement with a new robot manipulandum.
/maximum 1hour
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
/They can perform the reach movement about 10 cm on the horizontal plane desk.
/For around one hour, they can sit down on a chair.
Key exclusion criteria
/The condition of their disease is not stable.
/They have cognitive impairment, and cannot understand the task.
/In everyday life, there is defect in eyesight of the degree to need consideration for movement to need sight information, field of vision, the space recognition.
/A finger has the skin damage.
/A finger has an osteoarticular disease.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Ueno |
Organization
Department of Rehabilitation, University of Tsukuba Hospital
Division name
Department of Rehabilitation
Zip code
Address
2-1-1, Amakubo, Tsukuba. Ibaraki, Japan
TEL
029-853-3795
uenot@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Ueno |
Organization
Department of Rehabilitation, University of Tsukuba Hospital
Division name
Department of Rehabilitation
Zip code
Address
2-1-1, Amakubo, Tsukuba. Ibaraki, Japan
TEL
029-853-3795
Homepage URL
uenot@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
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
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 | 07 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 06 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 24 | Day |
Last modified on
| 2016 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026304
