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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000022874
Receipt No. 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

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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
Email 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
Email uenot@md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026304

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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