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

Recruiting

Phase N/A Results N/A

Trial Description

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

Conditions

Interventions

  • Control group Other
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Conventional
    Description: Conventional training group(control group)
  • Armeo Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Robot
    Description: Robot-Assisted upper arm training group(intervention group2)
  • Armeo and rTMS Device
    Other Names: Robot-Assisted upper arm training(Armeo); Repetitive Transcranial Magnetic Stimulation(rTMS)
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Robot and rTMS
    Description: Robot-Assisted upper arm training and Repetitive Transcranial Magnetic Stimulation group(intervention group 1)

Outcomes

Type Measure Time Frame Safety Issue
Primary Fugl-Meyer Assessment (FMA) 1 minute before the first intervention
Secondary Wolf motor function test 1 minute before the first intervention
Secondary Manual Function test 1 minute before the first intervention
Secondary Kinematic data of computerized 3D motion analysis 1 minute before the first intervention

Sponsors