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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot and rTMS | Experimental | Robot-Assisted upper arm training and Repetitive Transcranial Magnetic Stimulation group(intervention group 1) |
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| Robot | Experimental | Robot-Assisted upper arm training group(intervention group2) |
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| Conventional | Active Comparator | Conventional training group(control group) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Armeo and rTMS | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Rehabilitation Medicine, Severance Hospital, Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine | Seoul | 03722 | South Korea |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
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| Armeo | Device | 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. |
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| Control group | Other | 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. |
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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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |