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

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

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

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Armeo and rTMS; Device: Armeo; Other: Control group

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Department of Rehabilitation Medicine, Severance Hospital, Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2015
• Primary Completion (Actual): June 26, 2018
• Study Completion (Actual): June 26, 2018

Study Registration Dates

• First Submitted: January 30, 2017
• First Submitted That Met QC Criteria: February 1, 2017
• First Posted (Estimate): February 3, 2017

Study Record Updates

• Last Update Posted (Actual): March 18, 2019
• Last Update Submitted That Met QC Criteria: March 14, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 1-2014-0083

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No