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

P&S Mechanics Co., Ltd.91 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Stroke

Interventions

WalkbotDEVICE

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 therapyDEVICE

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

Eligibility

Sex: ALLMin age: 19 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (2)

National Rehabilitation Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea