Unique ID issued by UMIN | UMIN000035219 |
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Receipt number | 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 | 2020/12/14 12:32:22 |
Safety and feasibility study of mobility support using excretion support robot
Safety and feasibility study of excretion support robot
Safety and feasibility study of mobility support using excretion support robot
Safety and feasibility study of excretion support robot
Japan |
Patients with spinal cord injury, stroke, bone joint diseases, life inactive disease (disuse syndrome), and postoperative such as spinal disease and so on.
Medicine in general | Endocrinology and Metabolism | Neurology |
Surgery in general | Orthopedics | Neurosurgery |
Rehabilitation medicine |
Others
NO
To evaluate the safety and feasibility of the excretion support robot for people with motor impairment.
Safety
Safety (status of occurrence of adverse event, situation of malfunction of this equipment)
Feasibility (completion rate of movement using this equipment)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Other |
Move the setting course using the excretion support robot.
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
10
1st name | Akira |
Middle name | |
Last name | Matsumura |
Faculty of Medicine, University of Tsukuba
Division of Clinical Medicine, Department of Neurosurgery
305-8575
1-1-1 Tennodai, Tsukuba, Ibaraki Japan
029-853-3220
a-matsumur@md.tsukuba.ac.jp
1st name | Aiki |
Middle name | |
Last name | Marushima |
Faculty of Medicine, University of Tsukuba
Division of Clinical Medicine, Department of Neurosurgery, Emergency and Critical Care Medicine
305-8575
1-1-1 Tennodai Tsukuba, Ibaraki Japan
029-853-3220
aiki.marushima@md.tsukuba.ac.jp
University of Tsukuba
Japan Science and Technology Agency
Japanese Governmental office
University of Tsukuba
1-1-1 Tennodai Tsukuba, Ibaraki Japan
029-853-3914
t-credo.adm@un.tsukuba.ac.jp
NO
2018 | Year | 12 | Month | 11 | Day |
Unpublished
Preinitiation
2018 | Year | 11 | Month | 21 | Day |
2018 | Year | 12 | Month | 18 | Day |
2018 | Year | 12 | Month | 11 | Day |
2020 | Year | 12 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040135
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