UMIN-CTR Clinical Trial

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 Akira Middle name Last name Matsumura
Organization	Faculty of Medicine, University of Tsukuba
Division name	Division of Clinical Medicine, Department of Neurosurgery
Zip code	305-8575
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 Aiki Middle name Last name Marushima
Organization	Faculty of Medicine, University of Tsukuba
Division name	Division of Clinical Medicine, Department of Neurosurgery, Emergency and Critical Care Medicine
Zip code	305-8575
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	University of Tsukuba
Address	1-1-1 Tennodai Tsukuba, Ibaraki Japan
Tel	029-853-3914
Email	t-credo.adm@un.tsukuba.ac.jp

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	2020 Year 12 Month 14 Day

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