An interventional study of Walkbot group and Control group in Stroke, sponsored by Pusan National University. Completed at 1 site in South Korea. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2014-02-03.
Sponsored by Pusan National University · Not applicable, Interventional, and Treatment
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.
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.
7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's enrollment of 26 is below the median of 50 across 5,482 interventional studies indexed under Stroke.
Browse Stroke studies →Pusan National University is the lead sponsor of 17 studies on the registry; none are open to participants now.
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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.
Device: 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. 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.
Device: Control group
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.
Also known as: Walkbot
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.
Also known as: conventional treatment
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.
Time frame: within 4 weeks after robot training
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.
Time frame: within 4 weeks after robot training
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.
Time frame: within 4 weeks after robot training
EuroQol-5 dimension (EQ-5D)
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
The record gives a start of Jun 2013, a primary completion of Dec 2013 and a completion of Dec 2013. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Pusan National University