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Among subacute stroke patients (within 4 weeks after the onset), patients who are unable to walk are divided into experimental groups and control groups, and conventional rehabilitation treatment including physical therapy and occupational therapy is performed for 4 weeks or more in all groups.
Robot assisted inclined bed treatment and FES were performed, and the control group performed conventional inclined bed treatment.
The purpose of this study is to investigate the effect of robot-assisted inclined bed treatment by tracking observation and comparative analysis of the lower limb function, gait ability, bone density and muscle mass of each group.
Patients appropriate for the selection criteria are divided into experimental group and control group in random permuted blocks to conduct the study. In the experimental group, FES was performed at the same time as the robot-assisted inclined bed treatment once a day for 30 minutes, 5 days a week for 4 weeks, and the control group performed conventional inclined bed treatment for 30 minutes once a day for 4 weeks, 5 days a week. Separately from this in all groups, functional electrical stimulation treatment is performed once a day in the area except the lower extremities. In addition, all patients receive palliative physical therapy for 4 weeks for 1 hour a day. All subjects undergo a physical examination and whole body composition assessment before and after 4 weeks of treatment, and f/u after 4 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Robot assisted inclined bed treatment and FES |
|
| Control group | Active Comparator | conventional inclined bed treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robot assisted inclined bed treatment and FES | Device | FES was performed at the same time as the robot-assisted inclined bed treatment once a day for 30 minutes, 5 days a week for 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Assessment (lower) | A tool used to evaluate motor dysfunction, movement of the agonist and collaborator muscles, and coordination in stroke patients. It is used to evaluate motor function of the affected side. | before intervention |
| Fugl-Meyer Assessment (lower) | A tool used to evaluate motor dysfunction, movement of the agonist and collaborator muscles, and coordination in stroke patients. It is used to evaluate motor function of the affected side. | 4weeks after |
| Fugl-Meyer Assessment (lower) | A tool used to evaluate motor dysfunction, movement of the agonist and collaborator muscles, and coordination in stroke patients. It is used to evaluate motor function of the affected side. | 8weeks after |
| Motricity Index | A tool used to evaluate motor power. | before intervention |
| Motricity Index | A tool used to evaluate motor power. | 4weeks after |
| Motricity Index | A tool used to evaluate motor power. | 8weeks after |
| FAC (Functional ambulatory scale) | A tool to evaluate the independence of walking by measuring the degree of assistance required when walking. It is rated as 0-5 points. | before intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Deog Young Kim | Contact | 82-2-2228-3700 | kimdy@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| Deog Young Kim | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei Severance Hospital | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| conventional inclined bed treatment | Device | conventional inclined bed treatment for 30 minutes once a day for 4 weeks, 5 days a week |
|
| FAC (Functional ambulatory scale) | A tool to evaluate the independence of walking by measuring the degree of assistance required when walking. It is rated as 0-5 points. | 4weeks after |
| FAC (Functional ambulatory scale) | A tool to evaluate the independence of walking by measuring the degree of assistance required when walking. It is rated as 0-5 points. | 8weeks after |
| Locomotion level of FIM (functional independence measure) | Indicator to evaluate independence in performing daily life movements | before intervention |
| Locomotion level of FIM (functional independence measure) | Indicator to evaluate independence in performing daily life movements | 4weeks after |
| Locomotion level of FIM (functional independence measure) | Indicator to evaluate independence in performing daily life movements | 8weeks after |
| Berg balance scale | A tool to evaluate balance | before intervention |
| Berg balance scale | A tool to evaluate balance | 4weeks after |
| Berg balance scale | A tool to evaluate balance | 8weeks after |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |