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Completed

NCT Number: NCT03042455

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

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

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Rehabilitation Medicine, Severance Hospital, Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Robot-Assisted upper arm training(Armeo), Repetitive Transcranial Magnetic Stimulation(rTMS)

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.

Other names: Robot-Assisted upper arm training(Armeo)

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.

Other names: conventional training

Primary outcomes

  1. Fugl-Meyer Assessment (FMA)

    Time frame: 1 minute before the first intervention

    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. Fugl-Meyer Assessment (FMA)

    Time frame: 2 weeks after the first intervention

    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.

  3. Fugl-Meyer Assessment (FMA)

    Time frame: 4 weeks after the first intervention

    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. Fugl-Meyer Assessment (FMA)

    Time frame: 4 weeks after the final intervention

    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.

Secondary outcomes

  1. Wolf motor function test

    Time frame: 1 minute before the first intervention

    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. Wolf motor function test

    Time frame: 2 weeks after the first intervention

    The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks.

  3. Wolf motor function test

    Time frame: 4 weeks after the first intervention

    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. Wolf motor function test

    Time frame: 4 weeks after the final intervention

    The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks.

  5. Manual Function test

    Time frame: 1 minute before the first intervention

    The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.

  6. Manual Function test

    Time frame: 2 weeks after the first intervention

    The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.

  7. Manual Function test

    Time frame: 4 weeks after the first intervention

    The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.

  8. Manual Function test

    Time frame: 4 weeks after the final intervention

    The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.

  9. Kinematic data of computerized 3D motion analysis

    Time frame: 1 minute before the first intervention

    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

  10. Kinematic data of computerized 3D motion analysis

    Time frame: 2 weeks after the first intervention

    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

  11. Kinematic data of computerized 3D motion analysis

    Time frame: 4 weeks after the first intervention

    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

  12. Kinematic data of computerized 3D motion analysis

    Time frame: 4 weeks after the final intervention

    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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 3, 2017
Registry last updated
Mar 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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