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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04654793
• Other study ID #: 4-2017-0092
• Status: Recruiting
• Phase: N/A
• Start date: March 17, 2017
• Est. completion date: March 2023

Study information

• Verified date: December 2020
• Source: Yonsei University
• Contact: Deog Young Kim
• Phone: 82-2-2228-3700
• Email: kimdy[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: March 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• 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

Locations

Country	Name	City	State
Korea, Republic of	Yonsei Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Motricity Index	A tool used to evaluate motor power.	before intervention
Primary	Motricity Index	A tool used to evaluate motor power.	4weeks after
Primary	Motricity Index	A tool used to evaluate motor power.	8weeks after
Primary	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
Primary	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
Primary	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
Primary	Locomotion level of FIM (functional independence measure)	Indicator to evaluate independence in performing daily life movements	before intervention
Primary	Locomotion level of FIM (functional independence measure)	Indicator to evaluate independence in performing daily life movements	4weeks after
Primary	Locomotion level of FIM (functional independence measure)	Indicator to evaluate independence in performing daily life movements	8weeks after
Primary	Berg balance scale	A tool to evaluate balance	before intervention
Primary	Berg balance scale	A tool to evaluate balance	4weeks after
Primary	Berg balance scale	A tool to evaluate balance	8weeks after