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

Not Applicable

• Conditions: Stroke
• Interventions: Device: conventional inclined bed treatment; Device: Robot assisted inclined bed treatment and FES

• Registration Number: NCT04654793
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-17
• Study First Submitted: 2020-11-25
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-02
• Last Update Submitted: 2020-12-02
• Study First Posted: 2020-12-04
• Last Update Posted: 2020-12-04
• Primary Completion: 2022-12
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	conventional inclined bed treatment	conventional inclined bed treatment
Intervention group	Robot assisted inclined bed treatment and FES	Robot assisted inclined bed treatment and FES

Primary Outcome Measures

Name	Time	Method
Locomotion level of FIM (functional independence measure)	8weeks after	Indicator to evaluate independence in performing daily life movements
Fugl-Meyer Assessment (lower)	8weeks after	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.
Motricity Index	8weeks after	A tool used to evaluate motor power.
FAC (Functional ambulatory scale)	8weeks after	A tool to evaluate the independence of walking by measuring the degree of assistance required when walking. It is rated as 0-5 points.
Berg balance scale	8weeks after	A tool to evaluate balance

Trial Locations

Locations (1)

Yonsei Severance Hospital; 🇰🇷 Seoul, Korea, Republic of