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Combined Repetitive Transcranial Magnetic Stimulation and Robot-Assisted Upper Arm Training in Subacute Stroke Patients

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Armeo and rTMS
Armeo
Control group
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Upper FMA 7-38
  • Hemiplegic patients within 6months after stroke onset
  • male or female, 20 years older

Exclusion Criteria:

  • Patients with cognitive impairment who are unable to comply with protocol-required procedure
  • Quadriplegic or double hemiplegic patients
  • Patients with musculoskeletal disease, peripheral nerve disease in upper extremity
  • Patients with lower motor neuron disease
  • Patients who cannot perform rTMS
  • Pregnant woman

Sites / Locations

  • Department of Rehabilitation Medicine, Severance Hospital, Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Robot and rTMS

Robot

Conventional

Arm Description

Robot-Assisted upper arm training and Repetitive Transcranial Magnetic Stimulation group(intervention group 1)

Robot-Assisted upper arm training group(intervention group2)

Conventional training group(control group)

Outcomes

Primary Outcome Measures

Fugl-Meyer Assessment (FMA)
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
Fugl-Meyer Assessment (FMA)
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
Fugl-Meyer Assessment (FMA)
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
Fugl-Meyer Assessment (FMA)
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.

Secondary Outcome Measures

Wolf motor function test
The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks.
Wolf motor function test
The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks.
Wolf motor function test
The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks.
Wolf motor function test
The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks.
Manual Function test
The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.
Manual Function test
The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.
Manual Function test
The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.
Manual Function test
The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.
Kinematic data of computerized 3D motion analysis
D motion analysis will be performed using a computerized motion analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the task of drinking from a cup
Kinematic data of computerized 3D motion analysis
D motion analysis will be performed using a computerized motion analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the task of drinking from a cup
Kinematic data of computerized 3D motion analysis
D motion analysis will be performed using a computerized motion analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the task of drinking from a cup
Kinematic data of computerized 3D motion analysis
D motion analysis will be performed using a computerized motion analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the task of drinking from a cup

Full Information

First Posted
January 30, 2017
Last Updated
March 14, 2019
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT03042455
Brief Title
Combined Repetitive Transcranial Magnetic Stimulation and Robot-Assisted Upper Arm Training in Subacute Stroke Patients
Official Title
Combined Repetitive Transcranial Magnetic Stimulation and Robot-Assisted Upper Arm Training in Subacute Stroke Patients : Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 18, 2015 (Actual)
Primary Completion Date
June 26, 2018 (Actual)
Study Completion Date
June 26, 2018 (Actual)

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
This study was designed to establish the clinical evidence for effect of Robot-Assisted upper arm training and Repetitive Transcranial Magnetic Stimulation on upper limb function of subacute stroke patients. Purpose : to elucidate the effect of Robot-Assisted upper arm training and Repetitive Transcranial Magnetic Stimulation on upper limb function of stroke patients compared to conventional occupational therapy Subjects : total 99 patients with stroke whose upper limb functions are impaired Intervention : 4 weeks of therapy (5 days per week) Studies : upper limb functional assessment (FMA, MFT, WMFT), computerized motion analysis Evaluation plan : 1) pre-intervention, 2) post-2 weeks of intervention, 3) post-4 weeks of intervention, 4) 4 weeks after end of intervention

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
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Robot and rTMS
Arm Type
Experimental
Arm Description
Robot-Assisted upper arm training and Repetitive Transcranial Magnetic Stimulation group(intervention group 1)
Arm Title
Robot
Arm Type
Experimental
Arm Description
Robot-Assisted upper arm training group(intervention group2)
Arm Title
Conventional
Arm Type
Active Comparator
Arm Description
Conventional training group(control group)
Intervention Type
Device
Intervention Name(s)
Armeo and rTMS
Other Intervention Name(s)
Robot-Assisted upper arm training(Armeo), Repetitive Transcranial Magnetic Stimulation(rTMS)
Intervention Description
The Armeo, a robot with a spring mechanism allowing adjustable arm weight support, can generate assistive forces of up to 66N in flexion/extension and up to 30N for the arm and forearm respectively. This robot integrates seven angle sensors and one pressure sensor that allow direct interaction between the motion of the patient's arm and the associated therapy software. rTMS is a magnetic method used to stimulate small regions of the brain. The Robot and rTMS group will receive the robot-assisted upper arm training and rTMS for 5 times per week, for 4 weeks. And all patients of three groups will receive the additional conventional occupational therapy for 30 minutes daily 5 times per week, for 4 weeks.
Intervention Type
Device
Intervention Name(s)
Armeo
Other Intervention Name(s)
Robot-Assisted upper arm training(Armeo)
Intervention Description
The Armeo, a robot with a spring mechanism allowing adjustable arm weight support, can generate assistive forces of up to 66N in flexion/extension and up to 30N for the arm and forearm respectively. This robot integrates seven angle sensors and one pressure sensor that allow direct interaction between the motion of the patient's arm and the associated therapy software. The Robot group will receive the robot-assisted upper arm training for 30 minutes daily 5 times per week, for 4 weeks. And all patients of three groups will receive the additional conventional occupational therapy for 30 minutes daily 5 times per week, for 4 weeks.
Intervention Type
Other
Intervention Name(s)
Control group
Other Intervention Name(s)
conventional training
Intervention Description
The conventional group will receive occupational therapy for 30 minutes daily 5 times per week, for 4 weeks instead of Robot or rTMS. And all patients of three groups will receive the additional conventional occupational therapy for 30 minutes daily 5 times per week, for 4 weeks.
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment (FMA)
Description
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
Time Frame
1 minute before the first intervention
Title
Fugl-Meyer Assessment (FMA)
Description
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
Time Frame
2 weeks after the first intervention
Title
Fugl-Meyer Assessment (FMA)
Description
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
Time Frame
4 weeks after the first intervention
Title
Fugl-Meyer Assessment (FMA)
Description
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
Time Frame
4 weeks after the final intervention
Secondary Outcome Measure Information:
Title
Wolf motor function test
Description
The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks.
Time Frame
1 minute before the first intervention
Title
Wolf motor function test
Description
The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks.
Time Frame
2 weeks after the first intervention
Title
Wolf motor function test
Description
The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks.
Time Frame
4 weeks after the first intervention
Title
Wolf motor function test
Description
The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks.
Time Frame
4 weeks after the final intervention
Title
Manual Function test
Description
The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.
Time Frame
1 minute before the first intervention
Title
Manual Function test
Description
The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.
Time Frame
2 weeks after the first intervention
Title
Manual Function test
Description
The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.
Time Frame
4 weeks after the first intervention
Title
Manual Function test
Description
The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.
Time Frame
4 weeks after the final intervention
Title
Kinematic data of computerized 3D motion analysis
Description
D motion analysis will be performed using a computerized motion analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the task of drinking from a cup
Time Frame
1 minute before the first intervention
Title
Kinematic data of computerized 3D motion analysis
Description
D motion analysis will be performed using a computerized motion analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the task of drinking from a cup
Time Frame
2 weeks after the first intervention
Title
Kinematic data of computerized 3D motion analysis
Description
D motion analysis will be performed using a computerized motion analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the task of drinking from a cup
Time Frame
4 weeks after the first intervention
Title
Kinematic data of computerized 3D motion analysis
Description
D motion analysis will be performed using a computerized motion analysis system (VICON MX-T10 System with 6 infrared cameras, Oxford Metrics Inc., Oxford, UK) to measure the kinematic data (angle of each joint) during the task of drinking from a cup
Time Frame
4 weeks after the final intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Upper FMA 7-38 Hemiplegic patients within 6months after stroke onset male or female, 20 years older Exclusion Criteria: Patients with cognitive impairment who are unable to comply with protocol-required procedure Quadriplegic or double hemiplegic patients Patients with musculoskeletal disease, peripheral nerve disease in upper extremity Patients with lower motor neuron disease Patients who cannot perform rTMS Pregnant woman
Facility Information:
Facility Name
Department of Rehabilitation Medicine, Severance Hospital, Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Combined Repetitive Transcranial Magnetic Stimulation and Robot-Assisted Upper Arm Training in Subacute Stroke Patients

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