Back to resultsRobot-assisted Training for Stroke Recovery
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Walkbot group
Control group
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, robot-assisted therapy, conventional therapy, motor function
Eligibility Criteria
Inclusion Criteria:
- The subjects (age>19) with stroke 4 weeks after the onset but within 12 months were included.
Exclusion Criteria:
- Participated in the clinical studies, or received the rehabilitation therapy or therapy associated with the rehabilitation for the purpose of motor function improvement within thirty days before the start of this study.
- Cognitive disabilities or serious psychiatric illness.
- Difficulty in walking due to orthopedic problems.
- Ejection fraction less than 30% due to severe heart disease or with a diagnosis of unstable angina.
- Weight more than 135 kg or height less than 150 cm.
- Pregnancy subjects.
Sites / Locations
- Pusan National University Yangsan Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Walkbot group
control group
Arm Description
The Walkbot group received conventional physical therapy (session I for 40 min/day) companied with Walkbot training (session II for 30 min/day) 5 days a week for 4 weeks, 40 session in all. After 4-week intervention all subjects received conventional physical therapy only, 40 min/day, 5 days/week for 4 weeks.
The control group received conventional functional rehabilitation for 40 min/session, 2 sessions/day, 5 days/week for 4 weeks, 40 sessions in all. After 4-week intervention all subjects received conventional physical therapy only, 40 min/day, 5 days/week for 4 weeks. During the test period, general rehabilitation and drug treatment can be done at the same time.
Outcomes
Primary Outcome Measures
function ambulation category (FAC)
Function ambulation category was used for evaluating gait function. The outcome variable were measured immediately before treatment start (pre-training), 4 weeks after treatment (post-training) and 4 weeks after robot-treatment (follow-up). All the evaluations were done by the same professional therapist who was blind to the two group assignment.
Secondary Outcome Measures
Berg balance scale (BBS)
Berg balance scale (BBS) were used for evaluating functional performance level after training. The outcome variables were measured immediately before treatment start (pre-training), 4 weeks after treatment (post-training) and 4 weeks after robot-treatment (follow-up). All the evaluations were done by the same professional therapist who was blind to the two group assignment.
Korean modified Barthel index (K-MBI)
Korean modified Barthel index (K-MBI) were used for evaluating functional performance level after training. The outcome variables were measured immediately before treatment start (pre-training), 4 weeks after treatment (post-training) and 4 weeks after robot-treatment (follow-up). All the evaluations were done by the same professional therapist who was blind to the two group assignment.
Full Information
NCT ID
NCT02053233
First Posted
January 21, 2014
Last Updated
January 31, 2014
Sponsor
Pusan National University
1. Study Identification
Unique Protocol Identification Number
NCT02053233
Brief Title
Robot-assisted Training for Stroke Recovery
Official Title
Clinical Trial of Robot-assisted Training for Motor and Gait Recovery in Patients With Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The robot assisted therapy is one of the new developed technologies for recovery after stroke. This study aimed to evaluating the effect of robotic gait therapy for motor recovery after stroke.
Detailed Description
This study designed an assessor-blinded, randomized, controlled clinical study. The participations followed the study protocol and were randomly divided into the control group and Walkbot group. The control group received conventional functional rehabilitation for 40 min/session, 2 sessions/day, 5 days/week for 4 weeks, 40 sessions in all. Whereas the Walkbot group received conventional physical therapy (session I for 40 min/day) companied with Walkbot training (session II for 30 min/day) 5 days a week for 4 weeks, 40 session in all. After 4-week intervention all subjects received conventional physical therapy only, 40 min/day, 5 days/week for 4 weeks. During the test period, general rehabilitation and drug treatment can be done at the same time.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, robot-assisted therapy, conventional therapy, motor function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Walkbot group
Arm Type
Experimental
Arm Description
The Walkbot group received conventional physical therapy (session I for 40 min/day) companied with Walkbot training (session II for 30 min/day) 5 days a week for 4 weeks, 40 session in all. After 4-week intervention all subjects received conventional physical therapy only, 40 min/day, 5 days/week for 4 weeks.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
The control group received conventional functional rehabilitation for 40 min/session, 2 sessions/day, 5 days/week for 4 weeks, 40 sessions in all. After 4-week intervention all subjects received conventional physical therapy only, 40 min/day, 5 days/week for 4 weeks. During the test period, general rehabilitation and drug treatment can be done at the same time.
Intervention Type
Device
Intervention Name(s)
Walkbot group
Other Intervention Name(s)
Walkbot
Intervention Description
The physiotherapist typed patient's information then Walkbot would adjust itself to this data and the exoskeleton legs lengthen or shorten to the patient. The computer screen would provide information about speed, duration, cadence and distance. The monitor in front of the patient can offer image and feedback during the therapy process for patients.
The whole Walkbot training process was observed by one physiotherapist and should be always ready to adjust the unloading, duration, speed and guidance force of Walkbot according to patients' different situation such as muscle spasticity, gait quality, labor-consuming and observe the changes of patients' state.
Intervention Type
Device
Intervention Name(s)
Control group
Other Intervention Name(s)
conventional treatment
Intervention Description
The control group received conventional functional rehabilitation for 40 min/session, 2 sessions/day, 5 days/week for 4 weeks, 40 sessions in all. After 4-week intervention all subjects received conventional physical therapy only, 40 min/day, 5 days/week for 4 weeks. During the test period, general rehabilitation and drug treatment can be done at the same time.
Primary Outcome Measure Information:
Title
function ambulation category (FAC)
Description
Function ambulation category was used for evaluating gait function. The outcome variable were measured immediately before treatment start (pre-training), 4 weeks after treatment (post-training) and 4 weeks after robot-treatment (follow-up). All the evaluations were done by the same professional therapist who was blind to the two group assignment.
Time Frame
within 4 weeks after robot training
Secondary Outcome Measure Information:
Title
Berg balance scale (BBS)
Description
Berg balance scale (BBS) were used for evaluating functional performance level after training. The outcome variables were measured immediately before treatment start (pre-training), 4 weeks after treatment (post-training) and 4 weeks after robot-treatment (follow-up). All the evaluations were done by the same professional therapist who was blind to the two group assignment.
Time Frame
within 4 weeks after robot training
Title
Korean modified Barthel index (K-MBI)
Description
Korean modified Barthel index (K-MBI) were used for evaluating functional performance level after training. The outcome variables were measured immediately before treatment start (pre-training), 4 weeks after treatment (post-training) and 4 weeks after robot-treatment (follow-up). All the evaluations were done by the same professional therapist who was blind to the two group assignment.
Time Frame
within 4 weeks after robot training
Other Pre-specified Outcome Measures:
Title
EuroQol-5 dimension (EQ-5D)
Description
EuroQol-5 dimension (EQ-5D) was used for evaluating the effect of robot training to quality of life. The outcome variable was measured immediately before treatment start (pre-training), 4 weeks after treatment (post-training) and 4 weeks after robot-treatment (follow-up). All the evaluations were done by the same professional therapist who was blind to the two group assignment.
Time Frame
within 4 weeks after robot training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The subjects (age>19) with stroke 4 weeks after the onset but within 12 months were included.
Exclusion Criteria:
Participated in the clinical studies, or received the rehabilitation therapy or therapy associated with the rehabilitation for the purpose of motor function improvement within thirty days before the start of this study.
Cognitive disabilities or serious psychiatric illness.
Difficulty in walking due to orthopedic problems.
Ejection fraction less than 30% due to severe heart disease or with a diagnosis of unstable angina.
Weight more than 135 kg or height less than 150 cm.
Pregnancy subjects.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong-Il Shin, Ph.D.
Organizational Affiliation
Pusan National University Yangsan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
ZIP/Postal Code
626-770
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Robot-assisted Training for Stroke Recovery
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