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

A Multi-center, Parallel and Randomized Design Clinical Trial of Robot-assisted-gait-training (RAGT) in Stroke Patients to Evaluate Its Efficacy, Safety and Superiority Over Conventional Gait Training

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

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Walkbot; Device: Conventional physical therapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 01022
    • National Rehabilitation Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.; Device: Conventional physical therapy; Conventional physical therapy 30 minutes to be administered twice a day, 5 times a week for 3 weeks.
Active Comparator: Conventional physical therapy; Conventional physical therapy 30 minutes to be administered twice a day, 5 times a week for 3 weeks.	Device: Conventional physical therapy; Conventional physical therapy 30 minutes to be administered twice a day, 5 times a week for 3 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Functional Ambulation Category(FAC)	9 weeks from baseline

Secondary Outcome Measures

Outcome Measure	Time Frame
Motricity Index(MI)	9 weeks from baseline
10 Meter Walk Test(10MWT)	9 weeks from baseline
6 Minute Walk Test(6MWT)	9 weeks from baseline
Medical Research Council(MRC) Scale	9 weeks from baseline
Modified Ashworth Scale (MAS)	9 weeks from baseline
Fugl-Meyer Assessment(FMA) of Motor Recovery after Stroke	9 weeks from baseline
Modified Barthel Index(MBI)	9 weeks from baseline
National Institutes of Health Stroke Scale (NIHSS)	9 weeks from baseline
Beck's Depression Inventory test (BDI)	9 weeks from baseline
Treatment Satisfaction Survey	9 weeks from baseline

Collaborators and Investigators

• Sponsor: P&S Mechanics Co., Ltd.
• Investigators: Principal Investigator: Jung Hwan Kim, MD, PhD, National Rehabilitation Center, Korea

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: February 18, 2016
• First Submitted That Met QC Criteria: February 26, 2016
• First Posted (Estimate): February 29, 2016

Study Record Updates

• Last Update Posted (Estimate): September 27, 2016
• Last Update Submitted That Met QC Criteria: September 26, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Stroke
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: UMT2013-PS-WB-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO