Clinical Trial of Robot-assisted-gait-training (RAGT) in Stroke Patients
NCT ID: NCT02694302
Last Updated: 2016-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
91 participants
INTERVENTIONAL
2014-03-31
2016-07-31
Brief Summary
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Detailed Description
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Experimental group receives robot-assisted-gait-training and conventional gait training.
Active comparator group receives conventional gait training only as the same number as the experimental group.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Walkbot
Walkbot(robot assisted gait training) 30 minutes and conventional physical therapy 30 minutes each per day to be administered 5 times a week for 3 weeks.
Walkbot
Walkbot(robot assisted gait training) 30 minutes and conventional physical therapy 30 minutes each per day to be administered 5 times a week for 3 weeks.
Conventional physical therapy
Conventional physical therapy 30 minutes to be administered twice a day, 5 times a week for 3 weeks.
Conventional physical therapy
Conventional physical therapy 30 minutes to be administered twice a day, 5 times a week for 3 weeks.
Conventional physical therapy
Conventional physical therapy 30 minutes to be administered twice a day, 5 times a week for 3 weeks.
Interventions
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Walkbot
Walkbot(robot assisted gait training) 30 minutes and conventional physical therapy 30 minutes each per day to be administered 5 times a week for 3 weeks.
Conventional physical therapy
Conventional physical therapy 30 minutes to be administered twice a day, 5 times a week for 3 weeks.
Eligibility Criteria
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Inclusion Criteria
* Weight under 100kg
* Height less than 200cm
* Able to walk independently before onset of stroke
* Ischemic or hemorrhagic stroke patients
* Patients with motor paralysis and gait disturbance after stroke and seeking rehabilitation treatment
* FAC(Functional Ambulation Category) under 3 (0\~2)
* Subacute stroke patients after 3 days and before 3 months of onset
* Be informed of the nature of the study and agreed on written consent voluntarily
* Patients taking medications or scheduled medications due to stroke
Exclusion Criteria
* Uncontrolled stage 2 hypertension (systolic over 160 mmHg or diastolic more than 100mmHg) or with uncontrolled orthostatic hypotension
* Patients with cardiopulmonary disease or other underlying diseases that can not tolerate gait training
* Patients with severe skin damage and bedsore on wearing part of the trial device
* Pregnant or breast-feeding
* Participation within 30 days of the other clinical trials
* Patients whom the investigator considers inappropriate to participate in the study
19 Years
80 Years
ALL
No
Sponsors
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P&S Mechanics Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Jung Hwan Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
National Rehabilitation Center, Korea
Locations
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National Rehabilitation Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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UMT2013-PS-WB-01
Identifier Type: -
Identifier Source: org_study_id
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