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

Study Overview
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Brief Summary
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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

Official Title
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Combined Repetitive Transcranial Magnetic Stimulation and Robot-Assisted Upper Arm Training in Subacute Stroke Patients : Randomized Controlled Trial

Conditions
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Stroke

Intervention / Treatment
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* Device: Armeo and rTMS
* Device: Armeo
* Other: Control group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot and rTMS<br>Robot-Assisted upper arm training and Repetitive Transcranial Magnetic Stimulation group(intervention group 1) | Device: Armeo and rTMS<br>* 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.<br>* Other names: Repetitive Transcranial Magnetic Stimulation(rTMS);|
| Experimental: Robot<br>Robot-Assisted upper arm training group(intervention group2) | Device: Armeo<br>* 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.<br>* Other names: Robot-Assisted upper arm training(Armeo);|
| Active Comparator: Conventional<br>Conventional training group(control group) | Other: Control group<br>* 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.<br>* Other names: conventional training;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 minute before the first intervention | 
| 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. | 2 weeks after the first intervention | 
| 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. | 4 weeks after the first intervention | 
| 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. | 4 weeks after the final intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 minute before the first intervention | 
| 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. | 2 weeks after the first intervention | 
| 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. | 4 weeks after the first intervention | 
| 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. | 4 weeks after the final intervention | 
| Manual Function test | The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke. | 1 minute before the first intervention | 
| Manual Function test | The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke. | 2 weeks after the first intervention | 
| Manual Function test | The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke. | 4 weeks after the first intervention | 
| Manual Function test | The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke. | 4 weeks after the final intervention | 
| 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 | 1 minute before the first intervention | 
| 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 | 2 weeks after the first intervention | 
| 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 | 4 weeks after the first intervention | 
| 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 | 4 weeks after the final intervention |