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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03042455
• Other study ID #: 1-2014-0083
• Status: Completed
• Phase: N/A
• Start date: June 18, 2015
• Est. completion date: June 26, 2018

Study information

• Verified date: March 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: June 26, 2018
• Est. primary completion date: June 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Armeo and rTMS
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.
• Armeo
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.

Other:
• Control group
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.

Locations

Country	Name	City	State
Korea, Republic of	Department of Rehabilitation Medicine, Severance Hospital, Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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