UMIN-CTR Clinical Trial

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
Last 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
Email	mizuno.katsuhiro@gmail.com

Public contact
1st 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
Email	mizuno.katsuhiro@gmail.com

Sponsor
Institute	Keio University School of Medicine
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026136