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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: Walkbot; Device: Conventional physical therapy

• Registration Number: NCT02694302
• Lead Sponsor: P&S Mechanics Co., Ltd.

Brief Summary

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

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 Timeline

• Study Start: 2014-03
• Study First Submitted: 2016-02-18
• Study First Submitted QC: 2016-02-26
• Study First Posted: 2016-02-29
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-26
• Last Update Posted: 2016-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Functional Ambulation Category(FAC)	9 weeks from baseline

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

National Rehabilitation Center; 🇰🇷 Seoul, Korea, Republic of