UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and feasibility evaluation of the novel arm motion measurement device evaluatio for central nerve disorder patients
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Tomoyuki Ueno
Organization	Department of Rehabilitation, University of Tsukuba Hospital
Division name	Department of Rehabilitation
Address	2-1-1, Amakubo, Tsukuba. Ibaraki, Japan
TEL	029-853-3795
Email	uenot@md.tsukuba.ac.jp

Public contact
Name of contact person	Tomoyuki Ueno
Organization	Department of Rehabilitation, University of Tsukuba Hospital
Division name	Department of Rehabilitation
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 06 Month 03 Day
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

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Publication of results	Unpublished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