Stroke
Conditions
Brief summary
Purpose: To evaluate the effect of robotic gait therapy for brain reorganization in hemiplegia patients.
Detailed description
This study designed an interventional pre-post compared clinical study. The subjects received conventional physical therapy with Walkbot training (3 sessions per week for 7 weeks, 20 session). Before and after intervention all subjects evaluated using diffusion tensor imaging and clinical outcome measurements.
Interventions
DEVICEWalkbot
Robot assisted gait training
Sponsors
Veterans Health Service Medical Center, Seoul, Korea
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* First stroke attack * Within 3 months after stroke onset * Supratentorial stroke * Unilateral stroke
Exclusion criteria
* Bilateral stroke * infratentorial stroke * Cognitive disabilities or serious psychiatric illness. * Difficulty in walking due to orthopedic problems.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline fraction anisotropy of corticoreticular tract in Diffusion tensor imaging 8 weeks after the first day of intervention | at the first day of intervention and 8 weeks after the first day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional ambulation category | at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day | The functional ambulation category was designed to examine the levels of assistance required during a 15m walk. Six categories are included in the functional ambulation category: 0 (non-ambulatory), 1 (needs continuous support from one person), 2 (needs intermittent support from one person), 3 (needs only verbal supervision), 4 (help is required on stairs and uneven surfaces), and 5 (can walk independently anywhere). |
| Fugl-meyer assessment | at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day | — |
| Medical research council | at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day | The medical research council was designed to examine the muscle strength. Six categories are included in the medical research council: 5 (muscle contracts normally against full resistance), 4 (muscle strength is reduced but muscle contraction can still move joint against resistance), 3 (muscle strength is further reduced such that the joint can be moved only against gravity with the examiner's resistance completely removed. As an example, the elbow can be moved from full extension to full flexion starting with the arm hanging down at the side), 2 (muscle can move only if the resistance of gravity is removed. As an example, the elbow can be fully flexed only if the arm is maintained in a horizontal plane), 1 (only a trace or flicker of movement is seen or felt in the muscle or fasciculations are observed in the muscle) and 0 (no movement is observed) |
| Trunk control test | at the first day of intervention, 4 weeks, 8 weeks and 12 weeks after the first day | — |
Countries
South Korea
Outcome results
None listed