Clinical Trial of Robot-assisted-gait-training (RAGT) in Stroke Patients

NCT ID: NCT02694302

Last Updated: 2016-09-27

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-07-31

Brief Summary

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A clinical trial of robot-assisted-gait-training (RAGT) in stroke patients to evaluate its efficacy, safety over conventional gait training.

Detailed Description

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Robot-assisted-gait-training (RAGT) in stroke patients to evaluate its efficacy, safety over conventional gait training.

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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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Group Type EXPERIMENTAL

Walkbot

Intervention Type DEVICE

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

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

Conventional physical therapy

Intervention Type DEVICE

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.

Intervention Type DEVICE

Conventional physical therapy

Conventional physical therapy 30 minutes to be administered twice a day, 5 times a week for 3 weeks.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age more than 19 and under 80
* 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

* Patients with contraindications to weight bearing such as fractures, etc.
* 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
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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P&S Mechanics Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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UMT2013-PS-WB-01

Identifier Type: -

Identifier Source: org_study_id

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