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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: Armeo; Device: Armeo and rTMS; Other: Control group

• Registration Number: NCT03042455
• Lead Sponsor: Yonsei University

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-18
• Study First Submitted: 2017-01-30
• Study First Submitted QC: 2017-02-01
• Study First Posted: 2017-02-03
• Primary Completion: 2018-06-26
• Study Completion: 2018-06-26
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-14
• Last Update Posted: 2019-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• Upper FMA 7-38
• Hemiplegic patients within 6months after stroke onset
• male or female, 20 years older

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robot	Armeo	Robot-Assisted upper arm training group(intervention group2)
Robot and rTMS	Armeo and rTMS	Robot-Assisted upper arm training and Repetitive Transcranial Magnetic Stimulation group(intervention group 1)
Conventional	Control group	Conventional training group(control group)

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment (FMA)	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 Outcome Measures

Name	Time	Method
Manual Function test	4 weeks after the final intervention	The Manual Function Test (MFT) was developed to evaluate unilateral manual performance in hemiparetic patients after stroke.
Wolf motor function test	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.
Kinematic data of computerized 3D motion analysis	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

Trial Locations

Locations (1)

Department of Rehabilitation Medicine, Severance Hospital, Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of