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

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Robot assisted inclined bed treatment and FES
conventional inclined bed treatment
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Yonsei Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Control group

Arm Description

Robot assisted inclined bed treatment and FES

conventional inclined bed treatment

Outcomes

Primary Outcome Measures

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.
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.
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.
Motricity Index
A tool used to evaluate motor power.
Motricity Index
A tool used to evaluate motor power.
Motricity Index
A tool used to evaluate motor power.
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.
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.
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.
Locomotion level of FIM (functional independence measure)
Indicator to evaluate independence in performing daily life movements
Locomotion level of FIM (functional independence measure)
Indicator to evaluate independence in performing daily life movements
Locomotion level of FIM (functional independence measure)
Indicator to evaluate independence in performing daily life movements
Berg balance scale
A tool to evaluate balance
Berg balance scale
A tool to evaluate balance
Berg balance scale
A tool to evaluate balance

Secondary Outcome Measures

Full Information

First Posted
November 25, 2020
Last Updated
December 2, 2020
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT04654793
Brief Title
The Effect of Robotics-assisted Tilt Table and Functional Electrical Stimulation in Stroke Patients
Official Title
The Effect of Robotics-assisted Tilt Table and Functional Electrical Stimulation in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 17, 2017 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Robot assisted inclined bed treatment and FES
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
conventional inclined bed treatment
Intervention Type
Device
Intervention Name(s)
Robot assisted inclined bed treatment and FES
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
conventional inclined bed treatment
Intervention Description
conventional inclined bed treatment for 30 minutes once a day for 4 weeks, 5 days a week
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment (lower)
Description
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.
Time Frame
before intervention
Title
Fugl-Meyer Assessment (lower)
Description
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.
Time Frame
4weeks after
Title
Fugl-Meyer Assessment (lower)
Description
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.
Time Frame
8weeks after
Title
Motricity Index
Description
A tool used to evaluate motor power.
Time Frame
before intervention
Title
Motricity Index
Description
A tool used to evaluate motor power.
Time Frame
4weeks after
Title
Motricity Index
Description
A tool used to evaluate motor power.
Time Frame
8weeks after
Title
FAC (Functional ambulatory scale)
Description
A tool to evaluate the independence of walking by measuring the degree of assistance required when walking. It is rated as 0-5 points.
Time Frame
before intervention
Title
FAC (Functional ambulatory scale)
Description
A tool to evaluate the independence of walking by measuring the degree of assistance required when walking. It is rated as 0-5 points.
Time Frame
4weeks after
Title
FAC (Functional ambulatory scale)
Description
A tool to evaluate the independence of walking by measuring the degree of assistance required when walking. It is rated as 0-5 points.
Time Frame
8weeks after
Title
Locomotion level of FIM (functional independence measure)
Description
Indicator to evaluate independence in performing daily life movements
Time Frame
before intervention
Title
Locomotion level of FIM (functional independence measure)
Description
Indicator to evaluate independence in performing daily life movements
Time Frame
4weeks after
Title
Locomotion level of FIM (functional independence measure)
Description
Indicator to evaluate independence in performing daily life movements
Time Frame
8weeks after
Title
Berg balance scale
Description
A tool to evaluate balance
Time Frame
before intervention
Title
Berg balance scale
Description
A tool to evaluate balance
Time Frame
4weeks after
Title
Berg balance scale
Description
A tool to evaluate balance
Time Frame
8weeks after

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients within 4 weeks of onset of first stroke Patients with an FAC score of 1 or less and at least one lower limb FMA of 15 or less Adult male or female over 50 years of age Those who have consented in writing to this clinical trial A person who understands the purpose of the clinical trial and can adapt well to the treatment process Exclusion Criteria: Those with lower motor neuron lesions 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. Those with a history of bone metabolism related diseases such as thyroid or parathyroid disease (excluding osteopenia and osteoporosis) or bone tumor A person who has a history of fracture at the site of bone mineral density (ex. L1-L5, femoral head) Those who have skin ulcers or skin diseases such as open wounds that make it difficult to apply robotic therapy Those with the construction of the lower extremities Those with deep vein thrombosis or arterial vascular disease of the lower extremities Pregnant women Not appropriate according to the judgment of other researchers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deog Young Kim
Phone
82-2-2228-3700
Email
kimdy@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deog Young Kim
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deog Young Kim
Phone
82-2-2228-3700
Email
KIMDY@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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