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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035219
Receipt No. R000040135
Scientific Title Safety and feasibility study of mobility support using excretion support robot
Date of disclosure of the study information 2018/12/11
Last modified on 2018/12/11

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Basic information
Public title Safety and feasibility study of mobility support using excretion support robot
Acronym Safety and feasibility study of excretion support robot
Scientific Title Safety and feasibility study of mobility support using excretion support robot
Scientific Title:Acronym Safety and feasibility study of excretion support robot
Region
Japan

Condition
Condition Patients with spinal cord injury, stroke, bone joint diseases, life inactive disease (disuse syndrome), and postoperative such as spinal disease and so on.
Classification by specialty
Medicine in general Endocrinology and Metabolism Neurology
Surgery in general Orthopedics Neurosurgery
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and feasibility of the excretion support robot for people with motor impairment.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety (status of occurrence of adverse event, situation of malfunction of this equipment)
Feasibility (completion rate of movement using this equipment)
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 Treatment
Type of intervention
Other
Interventions/Control_1 Move the setting course using the excretion support robot.
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients who satisfy all the following criteria are targeted.
1. A patient who can consent to the document by himself/herself.
2. A patient aged 20 years or older at consent acquisition.
3. A patient whose height is approximately within 140-180 cm and whose weight is approximately within 40-100 kg.
4. A patient who have lower limb muscle weakness (Manual Muscle Testing: MMT 0 to 3).
5. A patient who require assistance or watching for standing, walking, excretion movement.
Key exclusion criteria Patients who conflict with one of the following criteria are excluded and not subject to this clinical study.
1. A patient who is judged to have the following findings by the research director or the research assignee.
1) A patient who have marked muscle weakness and motor paralysis on both side upper limbs (Manual Muscle Testing: MMT 0 to 1)
2) A patient with advanced immobility, contraction and ataxia.
3) A patient who have difficulty in rehabilitation in the training room.
4) A patient who is judged to be difficult to understand instructions (including patients who can not understand instructions and express their own condition due to aphasia).
5) A patient who have severe spasticity, deformation, contracture of the lower limbs, judged to be difficult to stand up and transfer.
2. A patient who is judged inappropriate to participate in the study by the research director or research assignee.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Matsumura
Organization Faculty of Medicine, University of Tsukuba
Division name Division of Clinical Medicine, Department of Neurosurgery
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki Japan
TEL 029-853-3220
Email a-matsumur@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Aiki Marushima
Organization Faculty of Medicine, University of Tsukuba
Division name Division of Clinical Medicine, Department of Neurosurgery, Emergency and Critical Care Medicine
Zip code
Address 1-1-1 Tennodai Tsukuba, Ibaraki Japan
TEL 029-853-3220
Homepage URL
Email aiki.marushima@md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2018 Year 12 Month 11 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
2018 Year 11 Month 21 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 18 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
2018 Year 12 Month 11 Day
Last modified on
2018 Year 12 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040135

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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