Clinical Trial of Robot-assisted Training for Motor and Gait Recovery in Patients With Stroke
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Pusan National University
- Enrollment
- 26
- Locations
- 2
- Primary Endpoint
- function ambulation category (FAC)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Walkbot group
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.
Intervention: Walkbot group (Device)
control 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.
Intervention: Control group (Device)
Outcomes
Primary Outcomes
function ambulation category (FAC)
Time Frame: within 4 weeks after robot training
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 Outcomes
- Berg balance scale (BBS)(within 4 weeks after robot training)
- Korean modified Barthel index (K-MBI)(within 4 weeks after robot training)
Investigators
Yong-il Shin
Professor
Pusan National University