UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022683 |
|---|---|
| Receipt number | R000026136 |
| Scientific Title | The development of gait and balance assistive exoskeletal robot and the effects in patients with stroke |
| Date of disclosure of the study information | 2016/06/09 |
| Last modified on | 2019/03/29 08:16:36 |
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Basic information
Public title
The development of gait and balance assistive exoskeletal robot and the effects in patients with stroke
Acronym
The effects of gait and balance assistive exoskeletal robot in patients with stroke
Scientific Title
The development of gait and balance assistive exoskeletal robot and the effects in patients with stroke
Scientific Title:Acronym
The effects of gait and balance assistive exoskeletal robot in patients with stroke
Region
| Japan |
Condition
Condition
Chronic stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To development and examine the effects of balance assistive exoskeletal robot in patients with stroke
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Motion analysis (joint angle, joint torque, and posturography) before, during, immediately after the intervention
Key secondary outcomes
Surface electromyography before, during, immediately after the intervention
Gait analysis, electroencephalogram, and electrophysiological assessment (motor-evoked potential, intracortical inhibition/ facilitation, spinal reciprocal inhibition) before and immediately after the intervention
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
| Device,equipment |
Interventions/Control_1
Robot-assisted balance control and stepping in standing position
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
Healthy subjects:
1.No medical history of motor musculoskeletal illness of lower extremity and neurological disorder
2.Agreement to participate in the research
Patients:
1.Hemiparetic stroke patients with motor disability of lower extremity
2.At least 6 months after the stroke
3.No medical history of fracture and injury by fall within 3 months
4.Able to understand and consent the objective and method of the study
5.Able to keep standing position safely with or without assistance
6.Agreement to participate in the research
Key exclusion criteria
Healthy subjects and patients:
1.Serious cardiac disease: unstable angina, myocardial infarction shortly after symptom onset, decompensated congestive heart failure, acute cor pulmonale, uncontrolled arrhythmia, serious aortic stenosis, active myocarditis, endocarditis, etc.
2.Uncontrolled hypertension
3.Acute systemic disease or fever
4.Complication of recent pulmonary embolism, acute cor pulmonale or serious pulmonary hypertension
5.Complication of serious liver or renal dysfunction
6.Complication of serious orthopedic disease which bars exercise capability
7.Complication of serious cognitive dysfunction or psychiatric disorder
8.Other metabolic abnormality (acute thyroiditis, etc.)
9.Serious contractures of leg joints
10.Implanted electronic pacing or defibrillation devices.
11.Surgical history of shunting or clipping
12.Medical history of epilepsy
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuhiro Mizuno |
Organization
Keio University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3833
mizuno.katsuhiro@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuhiro Mizuno |
Organization
Keio University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3833
Homepage URL
mizuno.katsuhiro@gmail.com
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
1.Advanced Telecommunications Research Institute International
2.Keio University School of Science and Technology
3.Tokyo Institute of Technology
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 06 | Month | 09 | 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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 29 | Day |
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 | 09 | Day |
Last modified on
| 2019 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026136
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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