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

P&S Mechanics

Status: Completed

Conditions: Stroke

Treatments: Device: Conventional physical therapy; Device: Walkbot

Study type: Interventional

Funder types: Industry

Identifiers

NCT02694302

UMT2013-PS-WB-01

Details and patient eligibility

About

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

Full description

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.

Enrollment: 91 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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91 participants in 2 patient groups

Walkbot

Experimental group

Description:

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.

Treatment:

Device: Walkbot

Device: Conventional physical therapy

Conventional physical therapy

Active Comparator group

Description:

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

Treatment:

Device: Conventional physical therapy