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

Yonsei University

Status: Completed

Conditions: Stroke

Treatments: Device: Armeo; Device: Armeo and rTMS; Other: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT03042455

1-2014-0083

Details and patient eligibility

About

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

Enrollment: 108 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 3 patient groups

Robot and rTMS

Experimental group

Description:

Robot-Assisted upper arm training and Repetitive Transcranial Magnetic Stimulation group(intervention group 1)

Treatment:

Device: Armeo and rTMS

Robot

Experimental group

Description:

Robot-Assisted upper arm training group(intervention group2)

Treatment:

Device: Armeo

Conventional

Active Comparator group

Description:

Conventional training group(control group)

Treatment:

Other: Control group