The Effect of Robotics-assisted Tilt Table and Functional Electrical Stimulation in Stroke Patients

Yonsei University

Status: Unknown

Conditions: Stroke

Treatments: Device: Robot assisted inclined bed treatment and FES; Device: conventional inclined bed treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04654793

4-2017-0092

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients within 4 weeks of onset of first stroke
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

1. Those with lower motor neuron lesions
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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Intervention group

Experimental group

Description:

Robot assisted inclined bed treatment and FES

Treatment:

Device: Robot assisted inclined bed treatment and FES

Control group

Active Comparator group

Description:

conventional inclined bed treatment

Treatment:

Device: conventional inclined bed treatment