The Effect of Robotics-assisted Tilt Table and Functional Electrical Stimulation in Stroke Patients
NCT ID: NCT04654793
Last Updated: 2020-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
48 participants
INTERVENTIONAL
2017-03-17
2023-03-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention group
Robot assisted inclined bed treatment and FES
Robot assisted inclined bed treatment and FES
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.
Control group
conventional inclined bed treatment
conventional inclined bed treatment
conventional inclined bed treatment for 30 minutes once a day for 4 weeks, 5 days a week
Interventions
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Robot assisted inclined bed treatment and FES
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.
conventional inclined bed treatment
conventional inclined bed treatment for 30 minutes once a day for 4 weeks, 5 days a week
Eligibility Criteria
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Inclusion Criteria
2. Patients with an FAC score of 1 or less and at least one lower limb FMA of 15 or less
3. Adult male or female over 50 years of age
4. Those who have consented in writing to this clinical trial
5. A person who understands the purpose of the clinical trial and can adapt well to the treatment process
Exclusion Criteria
2. A person who has an artificial implant due to a fracture of the lower extremity and spine, or a metal implant that generates an electrical signal such as an artificial pacemaker.
3. Those with a history of bone metabolism related diseases such as thyroid or parathyroid disease (excluding osteopenia and osteoporosis) or bone tumor
4. A person who has a history of fracture at the site of bone mineral density (ex. L1-L5, femoral head)
5. Those who have skin ulcers or skin diseases such as open wounds that make it difficult to apply robotic therapy
6. Those with the construction of the lower extremities
7. Those with deep vein thrombosis or arterial vascular disease of the lower extremities
8. Pregnant women
9. Not appropriate according to the judgment of other researchers
50 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Principal Investigators
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Deog Young Kim
Role: PRINCIPAL_INVESTIGATOR
Severance Hospital
Locations
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Yonsei Severance Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Deog Young Kim
Role: primary
Other Identifiers
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4-2017-0092
Identifier Type: -
Identifier Source: org_study_id