search
Back to results

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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Walkbot
Conventional physical therapy
Sponsored by
P&S Mechanics Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • National Rehabilitation Center
  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Walkbot

Conventional physical therapy

Arm 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.

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

Outcomes

Primary Outcome Measures

Functional Ambulation Category(FAC)

Secondary Outcome Measures

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

Full Information

First Posted
February 18, 2016
Last Updated
September 26, 2016
Sponsor
P&S Mechanics Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT02694302
Brief Title
Clinical Trial of Robot-assisted-gait-training (RAGT) in Stroke Patients
Acronym
Walkbot
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
P&S Mechanics Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Walkbot
Arm Type
Experimental
Arm 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.
Arm Title
Conventional physical therapy
Arm Type
Active Comparator
Arm Description
Conventional physical therapy 30 minutes to be administered twice a day, 5 times a week for 3 weeks.
Intervention Type
Device
Intervention Name(s)
Walkbot
Intervention 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.
Intervention Type
Device
Intervention Name(s)
Conventional physical therapy
Intervention Description
Conventional physical therapy 30 minutes to be administered twice a day, 5 times a week for 3 weeks.
Primary Outcome Measure Information:
Title
Functional Ambulation Category(FAC)
Time Frame
9 weeks from baseline
Secondary Outcome Measure Information:
Title
Motricity Index(MI)
Time Frame
9 weeks from baseline
Title
10 Meter Walk Test(10MWT)
Time Frame
9 weeks from baseline
Title
6 Minute Walk Test(6MWT)
Time Frame
9 weeks from baseline
Title
Medical Research Council(MRC) Scale
Time Frame
9 weeks from baseline
Title
Modified Ashworth Scale (MAS)
Time Frame
9 weeks from baseline
Title
Fugl-Meyer Assessment(FMA) of Motor Recovery after Stroke
Time Frame
9 weeks from baseline
Title
Modified Barthel Index(MBI)
Time Frame
9 weeks from baseline
Title
National Institutes of Health Stroke Scale (NIHSS)
Time Frame
9 weeks from baseline
Title
Beck's Depression Inventory test (BDI)
Time Frame
9 weeks from baseline
Title
Treatment Satisfaction Survey
Time Frame
9 weeks from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung Hwan Kim, MD, PhD
Organizational Affiliation
National Rehabilitation Center, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Rehabilitation Center
City
Seoul
ZIP/Postal Code
01022
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs